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

Report

• Report Number: 1020279-2025-01727
• Event Type: Injury
• Date Received: October 17, 2025
• Report Date: April 28, 2026
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: MBL
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: AS
• Reporter Occupation: OTHER
• Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

H11: THIS 3500A FORM IS BEING SUBMITTED AS A CORRECTION TO FOLLOW-UP REPORT 1020279-2025-01727, PREVIOUSLY SUBMITTED ON 17-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 1020279-2025-01727.

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 INCLUDES SIZE VARIANTS APPROVED FOR USE IN THE UNITED STATES UNDER PRO CODES MBL AND MEH. OF THE EIGHT HUNDRED AND FORTY-TWO (842) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, THREE HUNDRED SEVENTY-SEVEN (377) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR CUP APPROVED UNDER FDA PRODUCT CODE MBL. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 842 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE MBL. THE REPORTED REASONS FOR REVISION INCLUDE: ONE HUNDRED AND FORTY-FOUR (144) HIPS DUE TO FRACTURE, TWO HUNDRED AND FORTY (240) HIPS DUE TO LOOSENING, ONE HUNDRED AND THIRTY-FOUR (134) HIPS DUE TO INFECTION, ONE HUNDRED AND SIXTY-THREE (163) HIPS DUE TO PROSTHESIS DISLOCATION, SIXTY-EIGHT (68) HIPS DUE TO LYSIS, NINE (9) HIPS DUE TO PAIN, SEVEN (7) HIPS DUE TO INSTABILITY, SIX (6) HIPS DUE TO LEG LENGTH DISCREPANCY, SIX (6) HIPS DUE TO MALPOSITION, FIVE (5) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, FOUR (4) HIPS DUE TO METAL RELATED PATHOLOGY, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, FORTY-THREE (43) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, TWO (2) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, THREE (3) HIPS DUE TO INCORRECT SIZING, ONE (1) HIP DUE TO TUMOUR, ONE (1) HIP DUE TO HETEROTOPIC BONE, ONE (1) HIP DUE TO WEAR ¿ ACETABULUM AND FOUR (4) HIPS DUE TO OTHER-UNKNOWN CAUSES. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 842 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 377 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR CUP APPROVED UNDER FDA PRODUCT CODE MBL. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 377 CASES. -R3 XLPE LINER COMPONENTS: IMPLANTED IN THIRTY-THREE THOUSAND SIX HUNDRED AND FIFTY-FOUR (33,654) HIPS BETWEEN 4-DEC-2006 AND 21-FEB-2025. THIS INCLUDES SIZE VARIANTS APPROVED FOR USE IN THE UNITED STATES UNDER PRO CODES MBL AND JDI. OF THE ONE THOUSAND ONE HUNDRED AND SIXTY (1160) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, FIFTEEN (15) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A R3 XLPE LINER APPROVED UNDER FDA PRODUCT CODE MBL. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 1160 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE MBL. THE REPORTED REASONS FOR REVISION INCLUDE: TWO HUNDRED AND SIXTY (260) HIPS DUE TO FRACTURE, ONE HUNDRED FORTY-SEVEN (147) HIPS DUE TO LOOSENING, THREE HUNDRED TWELVE (312) HIPS DUE TO INFECTION, THREE HUNDRED EIGHT (308) HIPS DUE TO PROSTHESIS DISLOCATION, SIX (6) HIPS DUE TO LYSIS, EIGHTEEN (18) HIPS DUE TO PAIN, TWENTY ONE (21) HIPS DUE TO INSTABILITY, EIGHTEEN (18) HIPS DUE TO LEG LENGTH DISCREPANCY, SIXTEEN (16) HIPS DUE TO MALPOSITION, TWELVE (12) HIPS DUE TO BREAKAGE OF THE FEMORAL STEM, ONE (1) HIP DUE TO METAL RELATED PATHOLOGY, THREE (3) HIPS DUE TO BREAKAGE OF THE ACETABULAR INSERT, ONE (1) HIP DUE TO WEAR OF ACETABULAR INSERT, TWO (2) HIPS DUE TO BREAKAGE OF THE ACETABULAR SHELL, SEVEN (7) HIPS DUE TO INCORRECT SIZING, TWO (2) HIPS DUE TO TUMOUR FORMATION, FOUR (4) HIPS DUE TO HETEROTOPIC BONE AND TWENTY TWO (22) HIPS DUE TO OTHER-UNKNOWN REASONS. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 1,160 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 15 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED AN R3 XLPE LINERS APPROVED UNDER FDA PRODUCT CODE MBL. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 15 CASES. 2. REVISION THA PROCEDURES: -REFLECTION ACETABULAR SHELL COMPONENTS: IMPLANTED IN NINETY-FIVE (95) HIP JOINTS 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, FIVE (5) RE-REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR SHELL APPROVED UNDER FDA PRODUCT CODE MBL. 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 MBL. 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 5 RE-REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR SHELL APPROVED UNDER FDA PRODUCT CODE MBL. 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 5 CASES. -REFLECTION THREE-HOLE ACETABULAR SHELL COMPONENTS: IMPLANTED IN SIXTY-EIGHT (68) HIPS BETWEEN 23-OCT-2000 AND 24-JUL-2015. THIS TOTAL INCLUDES SIZE VARIANTS APPROVED FOR USE IN THE UNITED STATES UNDER PRO CODES MBL AND MEH. OF THE EIGHTEEN (15) RE-REVISION SURGERIES REPORTED FOR THESE IMPLANTS, FIVE (5) RE-REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION THREE-HOLE ACETABULAR SHELL APPROVED UNDER FDA PRODUCT CODE MBL. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR RE-REVISION FOR ALL 15 RE-REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO RE-REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE MBL. THE REPORTED REASONS FOR 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 15 RE-REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 5 RE-REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION THREE-HOLE ACETABULAR SHELL APPROVED UNDER FDA PRODUCT CODE MBL. 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 5 CASES. ALTOGETHER, A TOTAL QUANTITY OF AT LEAST THREE HUNDRED AND NINETY-TWO (392) REVISIONS AND TEN (10) RE-REVISIONS HAVE BEEN REPORTED IN THE AOANJRR FOR THE REFLECTION ACETABULAR SHELL COMPONENTS, R3 XLPE LINER COMPONENTS, AND REFLECTION THREE-HOLE ACETABULAR SHELL COMPONENTS RESULTING IN A TOTAL OF 402 EVENTS SUMMARIZED THROUGH THIS 3500A FORM. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE REFLECTION ACETABULAR SYSTEM AND R3 ACETABULAR SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED 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 REPORT FOR THE R3 XLPE LINER COMPONENTS REVEALED THAT THE 10-YEAR KAPLAN-MEIER REVISION RATE (4.2%) WAS SIGNIFICANTLY LOWER THAN THE CLASS DEVICE (4.8%) BASED ON THE NON-OVERLAPPING CONFIDENCE INTERVALS. FOR THE REFLECTION ACETABULAR SYSTEM COMPONENTS USED IN PRIMARY THA, THE AOANJRR REPORTS THAT THE REFLECTION SHELLS PERFORMED BETTER THAN ALL OTHER THAS ACROSS ALL AVAILABLE FOLLOW-UP YEARS BASED ON THE CUMULATIVE PERCENT REVISION. FOR THE REVISION THA, THE CUMULATIVE RE-REVISION RATE FOR ALL REFLECTION COMPONENTS USED DURING REVISION THA (16.0%) WERE IN LINE WITH THE CLASS (17.5%) AT 10 YEARS CONSIDERING THE OVERLAPPING CONFIDENCE INTERVALS. THE REASONS FOR RE-REVISION OF REFLECTION COMPONENTS WERE IN LINE WITH THE CLASS DEVICE DURING REVISION THA. SPECIFIC ANALYSIS 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.

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-2025-00279373-1-L1, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,58mm REFLECTION IT Three-Hole Acetabular Shell,71336058, ,71336058, ,03596010197573,K211176, ,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 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 shell 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) hip joints underwent revision THA procedures using a REFLECTION Acetabular Shell in lieu of the primary component 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, five (5) re-revisions were associated with hips that had previously received a REFLECTION Acetabular Shell approved under FDA product code MBL. ;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 MBL. 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 5 re-revisions associated with hips that had previously received a REFLECTION Acetabular Shell approved under FDA product code MBL. 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 5 cases. ;;Timeframe of Registry Data: Implantations conducted between 23-Oct-2000 and 24-Jul-2015 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 primary THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative re-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, ,0;CASE-2025-00279373-1-L2, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,60mm REFLECTION Three-Hole Acetabular Shell,71336060, ,71336060, ,03596010197580,K960094, ,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 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 shell 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) hip joints underwent revision THA procedures using a REFLECTION Acetabular Shell in lieu of the primary component 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, five (5) re-revisions were associated with hips that had previously received a REFLECTION Acetabular Shell approved under FDA product code MBL. ;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 MBL. 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 5 re-revisions associated with hips that had previously received a REFLECTION Acetabular Shell approved under FDA product code MBL. 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 5 cases. ;;Timeframe of Registry Data: Implantations conducted between 23-Oct-2000 and 24-Jul-2015 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 primary THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative re-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, ,0;CASE-2025-00279373-1-L3, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,60mm REFLECTION Three-Hole Acetabular Shell,71336060, ,71336060, ,03596010197580,K960094, ,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 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 shell 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) hip joints underwent revision THA procedures using a REFLECTION Acetabular Shell in lieu of the primary component 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, five (5) re-revisions were associated with hips that had previously received a REFLECTION Acetabular Shell approved under FDA product code MBL. ;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 MBL. 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 5 re-revisions associated with hips that had previously received a REFLECTION Acetabular Shell approved under FDA product code MBL. 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 5 cases. ;;Timeframe of Registry Data: Implantations conducted between 23-Oct-2000 and 24-Jul-2015 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 primary THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative re-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, ,0;CASE-2025-00279373-1-L4, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,54mm REFLECTION Three-Hole Acetabular Shell,71336454, ,71336454, ,03596010454362,K211176, ,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 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 shell 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) hip joints underwent revision THA procedures using a REFLECTION Acetabular Shell in lieu of the primary component 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, five (5) re-revisions were associated with hips that had previously received a REFLECTION Acetabular Shell approved under FDA product code MBL. ;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 MBL. 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 5 re-revisions associated with hips that had previously received a REFLECTION Acetabular Shell approved under FDA product code MBL. 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 5 cases. ;;Timeframe of Registry Data: Implantations conducted between 23-Oct-2000 and 24-Jul-2015 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 primary THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative re-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, ,0;CASE-2025-00279373-1-L5, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,58mm REFLECTION Three-Hole Acetabular Shell,71336458, ,71336458, ,03596010454386,K960094, ,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 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 shell 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) hip joints underwent revision THA procedures using a REFLECTION Acetabular Shell in lieu of the primary component 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, five (5) re-revisions were associated with hips that had previously received a REFLECTION Acetabular Shell approved under FDA product code MBL. ;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 MBL. 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 5 re-revisions associated with hips that had previously received a REFLECTION Acetabular Shell approved under FDA product code MBL. 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 5 cases. ;;Timeframe of Registry Data: Implantations conducted between 23-Oct-2000 and 24-Jul-2015 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 primary THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative re-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, ,0;CASE-2025-00279374-1-L1, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,K960094, ,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 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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 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 between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION Three-Hole Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. From this cohort, eighteen (15) hips underwent a re-revision surgery due to several causes. Of the eighteen (15) re-revision surgeries reported for these implants, five (5) re-revisions were associated with hips that had previously received a REFLECTION Three-Hole Acetabular Shell approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for re-revision for all 15 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MBL. The reported reasons for 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 15 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 5 re-revisions associated with hips that had previously received a REFLECTION Three-Hole Acetabular Shell approved under FDA product code MBL. 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 5 cases. ;;Timeframe of Registry data: Implantations conducted between 23-Oct-2000 and 24-Jul-2015 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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, ,0;CASE-2025-00279374-1-L2, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,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 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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 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 between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION Three-Hole Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. From this cohort, eighteen (15) hips underwent a re-revision surgery due to several causes. Of the eighteen (15) re-revision surgeries reported for these implants, five (5) re-revisions were associated with hips that had previously received a REFLECTION Three-Hole Acetabular Shell approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for re-revision for all 15 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MBL. The reported reasons for 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 15 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 5 re-revisions associated with hips that had previously received a REFLECTION Three-Hole Acetabular Shell approved under FDA product code MBL. 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 5 cases. ;;Timeframe of Registry data: Implantations conducted between 23-Oct-2000 and 24-Jul-2015 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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, ,0;CASE-2025-00279374-1-L3, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,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 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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 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 between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION Three-Hole Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. From this cohort, eighteen (15) hips underwent a re-revision surgery due to several causes. Of the eighteen (15) re-revision surgeries reported for these implants, five (5) re-revisions were associated with hips that had previously received a REFLECTION Three-Hole Acetabular Shell approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for re-revision for all 15 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MBL. The reported reasons for 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 15 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 5 re-revisions associated with hips that had previously received a REFLECTION Three-Hole Acetabular Shell approved under FDA product code MBL. 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 5 cases. ;;Timeframe of Registry data: Implantations conducted between 23-Oct-2000 and 24-Jul-2015 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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, ,0;CASE-2025-00279374-1-L4, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,K960094, ,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 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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 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 between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION Three-Hole Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. From this cohort, eighteen (15) hips underwent a re-revision surgery due to several causes. Of the eighteen (15) re-revision surgeries reported for these implants, five (5) re-revisions were associated with hips that had previously received a REFLECTION Three-Hole Acetabular Shell approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for re-revision for all 15 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MBL. The reported reasons for 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 15 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 5 re-revisions associated with hips that had previously received a REFLECTION Three-Hole Acetabular Shell approved under FDA product code MBL. 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 5 cases. ;;Timeframe of Registry data: Implantations conducted between 23-Oct-2000 and 24-Jul-2015 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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, ,0;CASE-2025-00279374-1-L5, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 58MM,71336458, ,71336458, ,03596010454386,K960094, ,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 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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 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 between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION Three-Hole Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. From this cohort, eighteen (15) hips underwent a re-revision surgery due to several causes. Of the eighteen (15) re-revision surgeries reported for these implants, five (5) re-revisions were associated with hips that had previously received a REFLECTION Three-Hole Acetabular Shell approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for re-revision for all 15 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MBL. The reported reasons for 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 15 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 5 re-revisions associated with hips that had previously received a REFLECTION Three-Hole Acetabular Shell approved under FDA product code MBL. 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 5 cases. ;;Timeframe of Registry data: Implantations conducted between 23-Oct-2000 and 24-Jul-2015 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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, ,0;CASE-2025-00279375-1-L1, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 46MM,71334046, ,71334046, ,03596010197276,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L2, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 46MM,71334046, ,71334046, ,03596010197276,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L3, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 48MM,71334048, ,71334048, ,03596010197283,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L4, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 48MM,71334048, ,71334048, ,03596010197283,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L5, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 48MM,71334048, ,71334048, ,03596010197283,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L6, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 48MM,71334048, ,71334048, ,03596010197283,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L7, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 48MM,71334048, ,71334048, ,03596010197283,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L8, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 50MM,71334050, ,71334050, ,03596010197290,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L9, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 50MM,71334050, ,71334050, ,03596010197290,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L10, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 50MM,71334050, ,71334050, ,03596010197290,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L11, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 50MM,71334050, ,71334050, ,03596010197290,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L12, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 50MM,71334050, ,71334050, ,03596010197290,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L13, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 50MM,71334050, ,71334050, ,03596010197290,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L14, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 50MM,71334050, ,71334050, ,03596010197290,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L15, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 50MM,71334050, ,71334050, ,03596010197290,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L16, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 52MM,71334052, ,71334052, ,03596010197306,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L17, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 52MM,71334052, ,71334052, ,03596010197306,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L18, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 52MM,71334052, ,71334052, ,03596010197306,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L19, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 52MM,71334052, ,71334052, ,03596010197306,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L20, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 52MM,71334052, ,71334052, ,03596010197306,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L21, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 52MM,71334052, ,71334052, ,03596010197306,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L22, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 52MM,71334052, ,71334052, ,03596010197306,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L23, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 52MM,71334052, ,71334052, ,03596010197306,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L24, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 52MM,71334052, ,71334052, ,03596010197306,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L25, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 52MM,71334052, ,71334052, ,03596010197306,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L26, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L27, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L28, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L29, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L30, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L31, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L32, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L33, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L34, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L35, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L36, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L37, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L38, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L39, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 54MM,71334054, ,71334054, ,03596010197313,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L40, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 56MM,71334056, ,71334056, ,03596010197320,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L41, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 56MM,71334056, ,71334056, ,03596010197320,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L42, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 56MM,71334056, ,71334056, ,03596010197320,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L43, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 56MM,71334056, ,71334056, ,03596010197320,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L44, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 56MM,71334056, ,71334056, ,03596010197320,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L45, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 56MM,71334056, ,71334056, ,03596010197320,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L46, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 56MM,71334056, ,71334056, ,03596010197320,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L47, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 56MM,71334056, ,71334056, ,03596010197320,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L48, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 56MM,71334056, ,71334056, ,03596010197320,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L49, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 56MM,71334056, ,71334056, ,03596010197320,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L50, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 56MM,71334056, ,71334056, ,03596010197320,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L51, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 56MM,71334056, ,71334056, ,03596010197320,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L52, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 58MM,71334058, ,71334058, ,03596010197337,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L53, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 58MM,71334058, ,71334058, ,03596010197337,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L54, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 58MM,71334058, ,71334058, ,03596010197337,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L55, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 58MM,71334058, ,71334058, ,03596010197337,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L56, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 58MM,71334058, ,71334058, ,03596010197337,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L57, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 58MM,71334058, ,71334058, ,03596010197337,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L58, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 58MM,71334058, ,71334058, ,03596010197337,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L59, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 58MM,71334058, ,71334058, ,03596010197337,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L60, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 60MM,71334060, ,71334060, ,03596010197344,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L61, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 60MM,71334060, ,71334060, ,03596010197344,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L62, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 62MM,71334062, ,71334062, ,03596010197351,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L63, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 62MM,71334062, ,71334062, ,03596010197351,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L64, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 62MM,71334062, ,71334062, ,03596010197351,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L65, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 62MM,71334062, ,71334062, ,03596010197351,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L66, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 64MM,71334064, ,71334064, ,03596010197368,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L67, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 64MM,71334064, ,71334064, ,03596010197368,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L68, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL NO HOLE SIZE 66MM,71334066, ,71334066, ,03596010197375,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L69, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 46MM,71334146, ,71334146, ,03596010455369,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L70, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 48MM,71334148, ,71334148, ,03596010455376,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L71, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 48MM,71334148, ,71334148, ,03596010455376,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L72, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 50MM,71334150, ,71334150, ,03596010455383,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L73, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 50MM,71334150, ,71334150, ,03596010455383,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L74, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 50MM,71334150, ,71334150, ,03596010455383,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L75, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 50MM,71334150, ,71334150, ,03596010455383,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L76, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 50MM,71334150, ,71334150, ,03596010455383,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L77, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 50MM,71334150, ,71334150, ,03596010455383,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L78, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 50MM,71334150, ,71334150, ,03596010455383,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L79, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SZ 52MM,71334152, ,71334152, ,03596010455390,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L80, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SZ 52MM,71334152, ,71334152, ,03596010455390,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L81, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SZ 52MM,71334152, ,71334152, ,03596010455390,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L82, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SZ 52MM,71334152, ,71334152, ,03596010455390,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L83, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SZ 52MM,71334152, ,71334152, ,03596010455390,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L84, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L85, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L86, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L87, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L88, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L89, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L90, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L91, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L92, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L93, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L94, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L95, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L96, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 54MM,71334154, ,71334154, ,03596010455406,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L97, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 56MM,71334156, ,71334156, ,03596010455413,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L98, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 56MM,71334156, ,71334156, ,03596010455413,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L99, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 56MM,71334156, ,71334156, ,03596010455413,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L100, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 56MM,71334156, ,71334156, ,03596010455413,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L101, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 56MM,71334156, ,71334156, ,03596010455413,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L102, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 56MM,71334156, ,71334156, ,03596010455413,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L103, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 56MM,71334156, ,71334156, ,03596010455413,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L104, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 56MM,71334156, ,71334156, ,03596010455413,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L105, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 56MM,71334156, ,71334156, ,03596010455413,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L106, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 56MM,71334156, ,71334156, ,03596010455413,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L107, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 58MM,71334158, ,71334158, ,03596010455420,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L108, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 58MM,71334158, ,71334158, ,03596010455420,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L109, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 58MM,71334158, ,71334158, ,03596010455420,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L110, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 58MM,71334158, ,71334158, ,03596010455420,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L111, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SIZE 60MM,71334160, ,71334160, ,03596010455437,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L112, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SZ 62MM,71334162, ,71334162, ,03596010455444,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L113, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SZ 62MM,71334162, ,71334162, ,03596010455444,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L114, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION NO HOLE SHELL SZ 62MM,71334162, ,71334162, ,03596010455444,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L115, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 44MM,71336044, ,71336044, ,03596010197504,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L116, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 46MM,71336046, ,71336046, ,03596010197511,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L117, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 46MM,71336046, ,71336046, ,03596010197511,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L118, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 46MM,71336046, ,71336046, ,03596010197511,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L119, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 46MM,71336046, ,71336046, ,03596010197511,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L120, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 48MM,71336048, ,71336048, ,03596010197528,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L121, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 48MM,71336048, ,71336048, ,03596010197528,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L122, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 48MM,71336048, ,71336048, ,03596010197528,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L123, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 48MM,71336048, ,71336048, ,03596010197528,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L124, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 48MM,71336048, ,71336048, ,03596010197528,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L125, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 48MM,71336048, ,71336048, ,03596010197528,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L126, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L127, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L128, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L129, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L130, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L131, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L132, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L133, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L134, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L135, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L136, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L137, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L138, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L139, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L140, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L141, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L142, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L143, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L144, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L145, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L146, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L147, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 50MM,71336050, ,71336050, ,03596010197535,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L148, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L149, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L150, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L151, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L152, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L153, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L154, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L155, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L156, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L157, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L158, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L159, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L160, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L161, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L162, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L163, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L164, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L165, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L166, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L167, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L168, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L169, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L170, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L171, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L172, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 52MM,71336052, ,71336052, ,03596010197542,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L173, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L174, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L175, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L176, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L177, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L178, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L179, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L180, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L181, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L182, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L183, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L184, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L185, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L186, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L187, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L188, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L189, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L190, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L191, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L192, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L193, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L194, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L195, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L196, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L197, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L198, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L199, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L200, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L201, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L202, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L203, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L204, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L205, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L206, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 54MM,71336054, ,71336054, ,03596010197559,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L207, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L208, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L209, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L210, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L211, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L212, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L213, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L214, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L215, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L216, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L217, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L218, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L219, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L220, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L221, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L222, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L223, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L224, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L225, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L226, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L227, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L228, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 56MM,71336056, ,71336056, ,03596010197566,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L229, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L230, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L231, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L232, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L233, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L234, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L235, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L236, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L237, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L238, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L239, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L240, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L241, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L242, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 58MM,71336058, ,71336058, ,03596010197573,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L243, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L244, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L245, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L246, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L247, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L248, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L249, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L250, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L251, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L252, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L253, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 60MM,71336060, ,71336060, ,03596010197580,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L254, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 62MM,71336062, ,71336062, ,03596010197597,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L255, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 62MM,71336062, ,71336062, ,03596010197597,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L256, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION INTERFIT ACETABULAR SHELL THREE HOLE SIZE 68MM,71336068, ,71336068, ,03596010197627,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L257, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 46MM,71336346, ,71336346, ,03596010460158,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L258, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 48MM,71336348, ,71336348, ,03596010454232,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L259, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 48MM,71336348, ,71336348, ,03596010454232,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L260, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 48MM,71336348, ,71336348, ,03596010454232,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L261, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 48MM,71336348, ,71336348, ,03596010454232,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L262, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 48MM,71336348, ,71336348, ,03596010454232,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L263, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 48MM,71336348, ,71336348, ,03596010454232,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L264, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 50MM,71336350, ,71336350, ,03596010454249,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L265, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 50MM,71336350, ,71336350, ,03596010454249,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L266, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 50MM,71336350, ,71336350, ,03596010454249,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L267, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 50MM,71336350, ,71336350, ,03596010454249,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L268, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 50MM,71336350, ,71336350, ,03596010454249,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L269, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 50MM,71336350, ,71336350, ,03596010454249,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L270, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 50MM,71336350, ,71336350, ,03596010454249,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L271, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 50MM,71336350, ,71336350, ,03596010454249,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L272, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 50MM,71336350, ,71336350, ,03596010454249,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L273, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 50MM,71336350, ,71336350, ,03596010454249,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L274, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 50MM,71336350, ,71336350, ,03596010454249,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L275, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 52MM,71336352, ,71336352, ,03596010454256,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L276, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 52MM,71336352, ,71336352, ,03596010454256,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L277, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 52MM,71336352, ,71336352, ,03596010454256,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L278, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 52MM,71336352, ,71336352, ,03596010454256,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L279, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 52MM,71336352, ,71336352, ,03596010454256,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L280, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 52MM,71336352, ,71336352, ,03596010454256,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L281, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 52MM,71336352, ,71336352, ,03596010454256,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L282, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 52MM,71336352, ,71336352, ,03596010454256,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L283, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 52MM,71336352, ,71336352, ,03596010454256,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L284, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 54MM,71336354, ,71336354, ,03596010454263,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L285, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 54MM,71336354, ,71336354, ,03596010454263,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L286, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 54MM,71336354, ,71336354, ,03596010454263,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L287, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 54MM,71336354, ,71336354, ,03596010454263,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L288, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 54MM,71336354, ,71336354, ,03596010454263,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L289, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 54MM,71336354, ,71336354, ,03596010454263,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L290, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L291, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L292, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L293, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L294, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L295, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L296, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L297, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L298, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L299, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L300, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L301, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L302, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L303, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 56MM,71336356, ,71336356, ,03596010454270,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L304, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 58MM,71336358, ,71336358, ,03596010454287,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L305, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 58MM,71336358, ,71336358, ,03596010454287,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L306, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 58MM,71336358, ,71336358, ,03596010454287,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L307, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 58MM,71336358, ,71336358, ,03596010454287,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L308, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 58MM,71336358, ,71336358, ,03596010454287,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L309, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 60MM,71336360, ,71336360, ,03596010454294,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L310, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 60MM,71336360, ,71336360, ,03596010454294,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L311, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 60MM,71336360, ,71336360, ,03596010454294,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L312, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 60MM,71336360, ,71336360, ,03596010454294,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L313, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 60MM,71336360, ,71336360, ,03596010454294,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L314, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 62MM,71336362, ,71336362, ,03596010454300,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L315, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 62MM,71336362, ,71336362, ,03596010454300,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L316, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION SPIKED SHELL SIZE 62MM,71336362, ,71336362, ,03596010454300,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L317, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 44MM,71336444, ,71336444, ,03596010460523,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L318, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 48MM,71336448, ,71336448, ,03596010454331,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L319, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 48MM,71336448, ,71336448, ,03596010454331,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L320, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 48MM,71336448, ,71336448, ,03596010454331,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L321, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 48MM,71336448, ,71336448, ,03596010454331,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L322, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 48MM,71336448, ,71336448, ,03596010454331,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L323, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 50MM,71336450, ,71336450, ,03596010454348,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L324, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 50MM,71336450, ,71336450, ,03596010454348,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L325, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 50MM,71336450, ,71336450, ,03596010454348,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L326, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 50MM,71336450, ,71336450, ,03596010454348,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L327, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 50MM,71336450, ,71336450, ,03596010454348,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L328, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 50MM,71336450, ,71336450, ,03596010454348,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L329, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 50MM,71336450, ,71336450, ,03596010454348,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L330, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 52MM,71336452, ,71336452, ,03596010454355,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L331, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 52MM,71336452, ,71336452, ,03596010454355,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L332, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 52MM,71336452, ,71336452, ,03596010454355,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L333, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 52MM,71336452, ,71336452, ,03596010454355,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L334, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 52MM,71336452, ,71336452, ,03596010454355,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L335, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 52MM,71336452, ,71336452, ,03596010454355,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L336, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 52MM,71336452, ,71336452, ,03596010454355,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L337, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 52MM,71336452, ,71336452, ,03596010454355,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L338, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 52MM,71336452, ,71336452, ,03596010454355,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L339, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 52MM,71336452, ,71336452, ,03596010454355,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L340, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L341, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L342, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L343, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L344, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L345, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L346, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L347, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L348, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L349, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L350, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L351, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L352, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L353, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 54MM,71336454, ,71336454, ,03596010454362,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L354, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 56MM,71336456, ,71336456, ,03596010454379,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L355, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 56MM,71336456, ,71336456, ,03596010454379,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L356, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 56MM,71336456, ,71336456, ,03596010454379,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L357, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 56MM,71336456, ,71336456, ,03596010454379,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L358, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 56MM,71336456, ,71336456, ,03596010454379,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L359, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 56MM,71336456, ,71336456, ,03596010454379,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L360, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 56MM,71336456, ,71336456, ,03596010454379,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L361, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 56MM,71336456, ,71336456, ,03596010454379,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L362, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 56MM,71336456, ,71336456, ,03596010454379,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L363, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 58MM,71336458, ,71336458, ,03596010454386,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L364, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 58MM,71336458, ,71336458, ,03596010454386,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L365, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 58MM,71336458, ,71336458, ,03596010454386,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L366, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 58MM,71336458, ,71336458, ,03596010454386,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L367, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 58MM,71336458, ,71336458, ,03596010454386,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L368, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 60MM,71336460, ,71336460, ,03596010454393,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L369, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 60MM,71336460, ,71336460, ,03596010454393,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L370, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 60MM,71336460, ,71336460, ,03596010454393,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 shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L371, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 62MM,71336462, ,71336462, ,03596010454409,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L372, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 62MM,71336462, ,71336462, ,03596010454409,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L373, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 62MM,71336462, ,71336462, ,03596010454409,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L374, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 62MM,71336462, ,71336462, ,03596010454409,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L375, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 64MM,71336464, ,71336464, ,03596010454416,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L376, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 66MM,71336466, ,71336466, ,03596010460486,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279375-1-L377, ,10/17/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION THREE HOLE SHELL SIZE 66MM,71336466, ,71336466, ,03596010460486,K960094, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual shell component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular Cup. This total includes size variants approved for use in the United States under PRO codes MBL and MEH. Of the eight hundred and forty-two (842) revision surgeries reported for these implants, three hundred seventy-seven (377) revisions were associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. ;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unknown causes. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 377 revisions associated with hips that had previously received a REFLECTION Acetabular Cup approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 377 cases.;;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,, , , , , ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279376-1-L1, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 44ID X 60 OD,71331106, ,71331106, ,03596010651945,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L2, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 56MM OUTER DIAMETER,71338687, ,71338687, ,00885556113189,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L3, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 56MM OUTER DIAMETER,71338687, ,71338687, ,00885556113189,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L4, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 56MM OUTER DIAMETER,71338687, ,71338687, ,00885556113189,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L5, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 56MM OUTER DIAMETER,71338687, ,71338687, ,00885556113189,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L6, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 58MM OUTER DIAMETER,71338688, ,71338688, ,00885556113172,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L7, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 58MM OUTER DIAMETER,71338688, ,71338688, ,00885556113172,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L8, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 58MM OUTER DIAMETER,71338688, ,71338688, ,00885556113172,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L9, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 60MM OUTER DIAMETER,71338689, ,71338689, ,00885556113165,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L10, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 60MM OUTER DIAMETER,71338689, ,71338689, ,00885556113165,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L11, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 60MM OUTER DIAMETER,71338689, ,71338689, ,00885556113165,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L12, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 62MM OUTER DIAMETER,71338690, ,71338690, ,00885556113158,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L13, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 62MM OUTER DIAMETER,71338690, ,71338690, ,00885556113158,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L14, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 62MM OUTER DIAMETER,71338690, ,71338690, ,00885556113158,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2025-00279376-1-L15, ,10/17/2025,4/10/2025,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 62MM OUTER DIAMETER,71338690, ,71338690, ,00885556113158,K093363, ,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner component reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirty-three thousand six hundred and fifty-four (33,654) hips underwent primary THA procedures between 4-Dec-2006 and 21-Feb-2025, using an R3 XLPE liner. This total includes size variants approved for use in the United States under PRO codes MBL and JDI. Of the one thousand one hundred and sixty (1,160) revision surgeries reported for these implants, fifteen (15) revisions were associated with hips that had previously received a R3 XLPE Liner approved under FDA product code MBL. ;;The AOANJRR report provides the complete list of reasons for revision for all 1160 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MBL. The reported reasons for revision include: two hundred and sixty (260) hips due to fracture, one hundred forty-seven (147) hips due to loosening, three hundred twelve (312) hips due to infection, three hundred eight (308) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty one (21) hips due to instability, eighteen (18) hips due to leg length discrepancy, sixteen (16) hips due to malposition, twelve (12) hips due to breakage of the femoral stem, one (1) hip due to metal related pathology, three (3) hips due to breakage of the acetabular insert, one (1) hip due to wear of acetabular insert, two (2) hips due to breakage of the acetabular shell, seven (7) hips due to incorrect sizing, two (2) hips due to tumour formation, four (4) hips due to heterotopic bone and twenty two (22) hips due to other-unknown reasons. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,160 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 15 revisions associated with hips that had previously received an R3 XLPE Liners approved under FDA product code MBL. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 15 cases. ;;Timeframe of Registry data: Implantations conducted between 4-Dec-2006 and 21-Feb-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirty-three thousand six hundred and fifty-four (33654) primary THA procedures with R3 XLPE liners have been performed in Australia between 4-Dec-2006 and 21-Feb-2025. The mean cumulative Kaplan-Meier revision rates for the R3 XLPE liner demonstrated a higher revision rate at 1 year compared to the class based on the non-overlapping confidence intervals. With the exception of the XLPE liner at 1 year, across 15 years of follow-up, the mean Kaplan-Meier revision rate for R3 XLPE were in line or lower than the class device when considering the confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 2.0% (1.9%-2.2%) vs 1.7% (1.7%-1.8%) of the class.;¿ At 2nd postoperative year: 2.4% (2.2%-2.6%) vs 2.2% (2.2%-2.2%) of the class.;¿ At 3rd postoperative year: 2.7% (2.5%-2.9%) vs 2.5% (2.5%-2.6%) of the class.;¿ At 4th postoperative year: 3.0% (2.8%-3.2%) vs 2.8% (2.8%-2.9%) of the class.;¿ At 5th postoperative year: 3.2% (3.0%-3.4%) vs 3.1% (3.1%-3.2%) of the class.;¿ At 6th postoperative year: 3.4% (3.2%-3.7%) vs 3.5% (3.4%-3.5%) of the class.;¿ At 7th postoperative year: 3.7% (3.5%-3.9%) vs 3.8% (3.7%-3.8%) of the class.;¿ At 8th postoperative year: 3.9% (3.7%-4.2%) vs 4.1% (4.0%-4.1%) of the class.;¿ At 9th postoperative year: 4.1% (3.8%-4.3%) vs 4.4% (4.4%-4.5%) of the class.;¿ At 10th postoperative year: 4.2% (3.9%-4.4%) vs 4.8% (4.7%-4.9%) of the class.;¿ At 11th postoperative year: 4.3% (4.1%-4.6%) vs 5.2% (5.1%-5.3%) of the class.;¿ At 12th postoperative year: 4.6% (4.3%-5.0%) vs 5.6% (5.5%-5.7%) of the class.;¿ At 13th postoperative year: 4.8% (4.5%-5.2%) vs 6.0% (6.0%-6.1%) of the class.;¿ At 14th postoperative year: 5.0% (4.6%-5.4%) vs 6.5% (6.4%-6.6%) of the class.;¿ At 15th postoperative year: 5.1% (4.7%-5.5%) vs 6.9% (6.9%-7.0%) of the class.;¿ At 16th postoperative year: 5.2% (4.7%-5.7%) vs 7.5% (7.4%-7.6%) of the class.;¿ At 17th postoperative year: 5.2% (4.7%-5.7%) vs 7.9% (7.8%-8.1%) of the class.;;This analysis applies to all R3 XLPE liners revised in the AOANJRR registry report, including variants registered in the U.S. under MBL and JDI PRO codes. To meet RWD2300584 requirements, part numbers for each PRO code are reported separately. However, the analysis itself covers both PRO code variants without distinction.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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, ,0;CASE-2026-00310376-1-L1,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L2,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L3,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L4,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L5,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L6,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L7,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L8,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L9,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L10,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L11,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L12,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L13,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L14,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L15,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L16,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L17,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L18,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L19,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L20,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L21,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L22,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L23,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L24,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L25,,4/27/2026,2/10/2026,Femoral Heads,40MM OXINIUM MODULAR FEMORAL HEAD,71342340,,71342340,,00885556112410,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L26,,4/27/2026,2/10/2026,Femoral Heads,44MM OXINIUM MODULAR FEMORAL HEAD,71342344,,71342344,,03596010652003,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;CASE-2026-00310376-1-L27,,4/27/2026,2/10/2026,Femoral Heads,40MM COCR MODULAR FEMORAL HEAD,71342640,,71342640,,00885556022603,K093363,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty-nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, one (1) hip was later revised 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: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of nine hundred fifty nine (959) hips underwent primary THA procedures between 24-Jul-2010 and 2-Dec-2025, using Oxinium & CoCr >32mm Modular Femoral Heads. From these, twenty?seven (27) hips were later revised due to the following complications: nine (9) hips due to fracture, six (6) hips due to loosening, six (6) hips due to infection, four (4) hips due to prosthesis dislocation, one (1) hip due to pain, one (1) hip due to leg length discrepancy. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 24-Jul-2010 and 2-Dec-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred fifty?nine (959) procedures with Oxinium & CoCr >32mm Modular Femoral Heads have been performed in Australia between 24-Jul-2010 and 2-Dec-2025.; ;The cumulative revision rates for the Oxinium & CoCr >32mm Modular Femoral Heads for primary THA performed in line with the class device at 10 years of follow-up based on the overlapping confidence intervalsa and better than the class on 12 to 14 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year:2.3% (1.5%¿3.5%) vs 1.7% (1.7%¿1.8%) of the class;-At 2nd postoperative year:2.4% (1.6%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;-At 3rd postoperative year:2.6% (1.7%¿3.9%) vs 2.5% (2.5%¿2.6%) of the class;-At 4th postoperative year:2.8% (1.9%¿4.1%) vs 2.8% (2.8%¿2.9%) of the class;-At 5th postoperative year:2.8% (1.9%¿4.1%) vs 3.1% (3.1%¿3.2%) of the class;-At 6th postoperative year:3.0% (2.0%¿4.4%) vs 3.4% (3.4%¿3.5%) of the class;-At 7th postoperative year:3.0% (2.0%¿4.4%) vs 3.7% (3.7%¿3.8%) of the class;-At 8th postoperative year:3.5% (2.4%¿5.2%) vs 4.0% (4.0%¿4.1%) of the class;-At 9th postoperative year:3.5% (2.4%¿5.2%) vs 4.4% (4.3%¿4.4%) of the class;-At 10th postoperative year:3.5% (2.4%¿5.2%) vs 4.7% (4.7%¿4.8%) of the class;-At 11th postoperative year:3.5% (2.4%¿5.2%) vs 5.1% (5.0%¿5.1%) of the class;-At 12th postoperative year:3.5% (2.4%¿5.2%) vs 5.5% (5.4%¿5.6%) of the class;-At 13th postoperative year:3.5% (2.4%¿5.2%) vs 5.9% (5.8%¿6.0%) of the class;-At 14th postoperative year:3.5% (2.4%¿5.2%) vs 6.3% (6.3%¿6.4%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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,,0;

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 INCLUDES SIZE VARIANTS APPROVED FOR USE IN THE UNITED STATES UNDER PRO CODES MBL AND MEH. OF THE EIGHT HUNDRED AND FORTY-TWO (842) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, THREE HUNDRED SEVENTY-SEVEN (377) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR CUP APPROVED UNDER FDA PRODUCT CODE MBL. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 842 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE MBL. THE REPORTED REASONS FOR REVISION INCLUDE: ONE HUNDRED AND FORTY-FOUR (144) HIPS DUE TO FRACTURE, TWO HUNDRED AND FORTY (240) HIPS DUE TO LOOSENING, ONE HUNDRED AND THIRTY-FOUR (134) HIPS DUE TO INFECTION, ONE HUNDRED AND SIXTY-THREE (163) HIPS DUE TO PROSTHESIS DISLOCATION, SIXTY-EIGHT (68) HIPS DUE TO LYSIS, NINE (9) HIPS DUE TO PAIN, SEVEN (7) HIPS DUE TO INSTABILITY, SIX (6) HIPS DUE TO LEG LENGTH DISCREPANCY, SIX (6) HIPS DUE TO MALPOSITION, FIVE (5) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, FOUR (4) HIPS DUE TO METAL RELATED PATHOLOGY, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, FORTY-THREE (43) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, TWO (2) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, THREE (3) HIPS DUE TO INCORRECT SIZING, ONE (1) HIP DUE TO TUMOUR, ONE (1) HIP DUE TO HETEROTOPIC BONE, ONE (1) HIP DUE TO WEAR ¿ ACETABULUM AND FOUR (4) HIPS DUE TO OTHER-UNKNOWN CAUSES. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 842 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 377 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR CUP APPROVED UNDER FDA PRODUCT CODE MBL. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 377 CASES. -R3 XLPE LINER COMPONENTS: IMPLANTED IN THIRTY-THREE THOUSAND SIX HUNDRED AND FIFTY-FOUR (33,654) HIPS BETWEEN 4-DEC-2006 AND 21-FEB-2025. THIS INCLUDES SIZE VARIANTS APPROVED FOR USE IN THE UNITED STATES UNDER PRO CODES MBL AND JDI. OF THE ONE THOUSAND ONE HUNDRED AND SIXTY (1160) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, FIFTEEN (15) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A R3 XLPE LINER APPROVED UNDER FDA PRODUCT CODE MBL. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 1160 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE MBL. THE REPORTED REASONS FOR REVISION INCLUDE: TWO HUNDRED AND SIXTY (260) HIPS DUE TO FRACTURE, ONE HUNDRED FORTY-SEVEN (147) HIPS DUE TO LOOSENING, THREE HUNDRED TWELVE (312) HIPS DUE TO INFECTION, THREE HUNDRED EIGHT (308) HIPS DUE TO PROSTHESIS DISLOCATION, SIX (6) HIPS DUE TO LYSIS, EIGHTEEN (18) HIPS DUE TO PAIN, TWENTY ONE (21) HIPS DUE TO INSTABILITY, EIGHTEEN (18) HIPS DUE TO LEG LENGTH DISCREPANCY, SIXTEEN (16) HIPS DUE TO MALPOSITION, TWELVE (12) HIPS DUE TO BREAKAGE OF THE FEMORAL STEM, ONE (1) HIP DUE TO METAL RELATED PATHOLOGY, THREE (3) HIPS DUE TO BREAKAGE OF THE ACETABULAR INSERT, ONE (1) HIP DUE TO WEAR OF ACETABULAR INSERT, TWO (2) HIPS DUE TO BREAKAGE OF THE ACETABULAR SHELL, SEVEN (7) HIPS DUE TO INCORRECT SIZING, TWO (2) HIPS DUE TO TUMOUR FORMATION, FOUR (4) HIPS DUE TO HETEROTOPIC BONE AND TWENTY TWO (22) HIPS DUE TO OTHER-UNKNOWN REASONS. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 1,160 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 15 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED AN R3 XLPE LINERS APPROVED UNDER FDA PRODUCT CODE MBL. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 15 CASES. 2. REVISION THA PROCEDURES: -REFLECTION ACETABULAR SHELL COMPONENTS: IMPLANTED IN NINETY-FIVE (95) HIP JOINTS 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, FIVE (5) RE-REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR SHELL APPROVED UNDER FDA PRODUCT CODE MBL. 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 MBL. 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 5 RE-REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR SHELL APPROVED UNDER FDA PRODUCT CODE MBL. 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 5 CASES. -REFLECTION THREE-HOLE ACETABULAR SHELL COMPONENTS: IMPLANTED IN SIXTY-EIGHT (68) HIPS BETWEEN 23-OCT-2000 AND 24-JUL-2015. THIS TOTAL INCLUDES SIZE VARIANTS APPROVED FOR USE IN THE UNITED STATES UNDER PRO CODES MBL AND MEH. OF THE EIGHTEEN (15) RE-REVISION SURGERIES REPORTED FOR THESE IMPLANTS, FIVE (5) RE-REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION THREE-HOLE ACETABULAR SHELL APPROVED UNDER FDA PRODUCT CODE MBL. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR RE-REVISION FOR ALL 15 RE-REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO RE-REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE MBL. THE REPORTED REASONS FOR 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 15 RE-REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 5 RE-REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION THREE-HOLE ACETABULAR SHELL APPROVED UNDER FDA PRODUCT CODE MBL. 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 5 CASES. ALTOGETHER, A TOTAL QUANTITY OF AT LEAST THREE HUNDRED AND NINETY-TWO (392) REVISIONS AND TEN (10) RE-REVISIONS HAVE BEEN REPORTED IN THE AOANJRR FOR THE REFLECTION ACETABULAR SHELL COMPONENTS, R3 XLPE LINER COMPONENTS, AND REFLECTION THREE-HOLE ACETABULAR SHELL COMPONENTS RESULTING IN A TOTAL OF 402 EVENTS SUMMARIZED THROUGH THIS 3500A FORM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
616263		PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS	MBL	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR	Unknown

Terms

Patient problem · 15

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

Product problems · 6

• Adverse Event Without Identified Device or Use Problem
• Fracture
• Improper or Incorrect Procedure or Method
• Loosening of Implant Not Related to Bone-Ingrowth
• Material Erosion
• Osseointegration Problem

Source type · 1

• Other

Type of report · 2

• Followup
• Initial submission