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

Report

• Report Number: 1020279-2025-01694
• Event Type: Injury
• Date Received: October 15, 2025
• Report Date: April 27, 2026
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: LPH
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: IL, US
• Reporter Occupation: OTHER
• Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 3 (JUL 1 - SEP 30, 2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AMERICAN JOINT REPLACEMENT REGISTRY (AJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE UNITED STATES FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY JOINT REPLACEMENT PROCEDURES: 1. PRIMARY THA PROCEDURES: OR3O LINER-INSERT COMPONENT + R3 SHELL: A TOTAL OF FIVE THOUSAND AND THIRTY-TWO (5,032) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 1-JAN-2020 AND 30-JUN-2025. FROM THESE, ONE HUNDRED AND SEVENTEEN (117) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: THIRTY-NINE (39) HIPS DUE TO INFECTION, SIXTEEN (16) HIPS DUE TO ASEPTIC LOOSENING, THIRTY-FOUR (34) HIPS DUE TO FRACTURE , TWENTY-EIGHT (28) HIPS DUE TO DISLOCATIONS, LESS THAN ELEVEN (11) HIPS DUE TO HEMATOMA OR UNSPECIFIED WOUND COMPLICATIONS, LESS THAN ELEVEN (11) HIPS DUE TO INSTABILITY, SIXTEEN (16) HIPS DUE TO UNSPECIFIED MECHANICAL COMPLICATIONS, TWENTY-SEVEN (27) HIPS DUE TO PERIPROSTHETIC FRACTURE, EIGHTEEN (18) HIPS DUE TO UNSPECIFIED PAIN, LESS THAN ELEVEN (11) HIPS DUE TO WEAR OR OSTEOLYSIS AND LESS THAN ELEVEN (11) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY. IN ADDITION, THE AJRR REPORT DOES NOT PROVIDE AN EXACT NUMBER OF REVISIONS FOR THOSE REASONS ACCOUNTING FOR LESS THAN 11 CASES. ALTOGETHER, A TOTAL QUANTITY OF AT LEAST 117 REVISIONS HAVE BEEN REPORTED IN THE AJRR FOR THE OR3O LINER-INSERT COMPONENT WITH AN R3 SHELL. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE OR3O DUAL MOBILITY SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AN AJRR REPORT FOR THE OR3O DUAL MOBILITY (LINER- INSERT) SYSTEM PROVIDED DATA USAGE IN PRIMARY THAS IN COMBINATION WITH R3 SHELLS. THE CUMULATIVE REVISION RATES REPORTED ARE IN LINE WITH THE AJRR THA CLASS ACROSS ALL AVAILABLE YEARS OF FOLLOW-UP. SPECIFIC ANALYSIS FOR EACH COMBINATION 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-2025-00285820-1-L1, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L2, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L3, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L4, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L5, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L6, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L7, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L8, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L9, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L10, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L11, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L12, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L13, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L14, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L15, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L16, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L17, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L18, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L19, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L20, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L21, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L22, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L23, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L24, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L25, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L26, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L27, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L28, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L29, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L30, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L31, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L32, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L33, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L34, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L35, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L36, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L37, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L38, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L39, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L40, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L41, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L42, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L43, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L44, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L45, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L46, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L47, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L48, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L49, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L50, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L51, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L52, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L53, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L54, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L55, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L56, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L57, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L58, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L59, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L60, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L61, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L62, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L63, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L64, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L65, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L66, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L67, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L68, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L69, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L70, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L71, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L72, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L73, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L74, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L75, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L76, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L77, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L78, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L79, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L80, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L81, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L82, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L83, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L84, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L85, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L86, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L87, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L88, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L89, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L90, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L91, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L92, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L93, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L94, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L95, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L96, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L97, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L98, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L99, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L100, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L101, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L102, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L103, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L104, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L105, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L106, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L107, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L108, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L109, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L110, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L111, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L112, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L113, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L114, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L115, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L116, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L117, ,10/13/2025,8/26/2025,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner, , , , , ,K191002, ,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner-insert component with an R3 shell. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual OR3O liner-insert component reported through this line item.","Reporting Quarter: 3 (July 1st to September 30th) 2025;;Summary of adverse events: It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of five thousand and thirty-two (5,032) hips underwent primary THA procedures between 1-Jan-2020 and 30-Jun-2025, using OR3O liner- insert component with an R3 shell. From these, one hundred and seventeen (117) hips were later revised due to the following reasons: Thirty-nine (39) hips due to infection, sixteen (16) hips due to aseptic loosening, thirty-four (34) hips due to fracture, twenty-eight (28) hips due to dislocations, less than eleven (11) hips due to hematoma or unspecified wound complications, less than eleven (11) hips due to instability, sixteen (16) hips due to unspecified mechanical complications, twenty-seven (27) hips due to periprosthetic fracture, eighteen (18) hips due to unspecified pain, less than eleven (11) hips due to wear or osteolysis and less thaneleven (11) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. The specific reasons for each revision procedure cannot be distinctly matched based on the data stratification provided by the Joint Registry. ;;Timeframe of Registry data: Implantations conducted between 1-Jan-2020 and 30-Jun-2025 in the United States ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of five thousand and thirty-two (5,032) primary THA procedures using OR3O liner-insert component with an R3 shell have been performed in the United States between 1-Jan-2020 and 30-Jun-2025. The mean cumulative revision rates for the OR3O liner or insert with an R3 shell in primary THA are in line with the class though 5 years of follow-up based on overlapping 95% confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 1.94% (1.59%¿2.29%) vs 2.13% (2.04%¿2.23%) of the class. ;;-At 2nd postoperative year: 2.32% (1.90%¿2.74%) vs 2.56% (2.45%¿2.67%) of the class. ;;-At 3rd postoperative year: 2.66% (2.18%¿3.14%) vs 2.93% (2.81%¿3.05%) of the class. ;;-At 4th postoperative year: 2.89% (2.37%¿3.41%) vs 3.19% (3.06%¿3.32%) of the class. ;;-At 5th postoperative year: 3.11% (2.55%¿3.67%) vs 3.42% (3.29%¿3.56%) of the class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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. ", ,68, , , , ,,F1905,,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L118,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L119,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L120,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L121,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L122,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L123,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L124,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L125,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L126,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L127,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L128,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L129,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L130,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L131,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L132,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00285820-1-L133,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, one (1) hip was revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA between 01-Jan-2012 and 31-Dec-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with an R3 Acetabular Shell. Of these, a hundred and thirty-three (133) hips required revision due to the following reasons: thirty four (34) hips due to fracture, forty four (44) due to infection, eighteen (18) due to aseptic loosening, less than eleven (11) hips due to instability, thirty one (31) due to dislocation, sixteen (16) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, eighteen (18) due to pain, twenty seven (27) due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for revision may be listed to a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 31-Dec-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred and thirty-five (6,235) hips underwent primary THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2012 and 31-Dec-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 0.20% (0.10%¿0.29%) vs 0.15% (0.11%¿0.18%) of the class.;? At 2nd postoperative year: 0.32% (0.17%¿0.46%) vs 0.23% (0.19%¿0.27%) of the class.;? At 3rd postoperative year: 0.38% (0.20%¿0.56%) vs 0.28% (0.23%¿0.33%) of the class.;? At 4th postoperative year: 0.39% (0.21%¿0.58%) vs 0.29% (0.24%¿0.34%) of the class.;? At 5th postoperative year: 0.41% (0.22%¿0.60%) vs 0.30% (0.25%¿0.36%) of the class.;By observing the cumulative aseptic loosening revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate THA class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00317336-1-L1,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L2,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L3,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L4,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L5,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L6,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L7,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L8,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L9,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L10,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L11,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L12,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L13,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L14,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L15,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L16,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L17,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L18,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L19,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L20,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L21,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L22,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L23,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L24,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L25,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L26,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L27,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L28,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L29,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L30,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L31,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L32,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L33,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L34,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L35,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L36,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L37,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L38,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L39,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L40,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L41,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L42,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L43,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L44,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L45,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L46,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L47,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L48,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L49,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L50,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L51,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L52,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L53,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L54,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L55,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L56,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L57,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L58,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L59,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L60,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L61,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L62,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L63,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L64,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L65,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L66,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L67,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L68,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L69,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L70,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L71,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L72,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L73,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L74,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L75,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L76,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L77,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L78,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L79,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L80,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L81,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L82,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L83,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L84,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L85,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L86,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L87,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317336-1-L88,,4/27/2026,3/11/2026,OR3O Dual Mobility System,OR3O Dual Mobility Insert or Liner ,,,,,,K191002,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025, using an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand and thirty-seven (1,037) hips underwent revision THA between 01-Jan-2020 and 30-Jun-2025 in which an OR3O Dual Mobility Insert or Liner was implanted along with a REDAPT Acetabular Shell. Of these, eighty-eight (88) hips required re-revision due to the following reasons: thirteen (13) hips due to fracture, thirty?seven (37) due to infection, eleven (11) due to aseptic loosening, forty (40) due to dislocation, fourteen (14) due to mechanical complications, less than eleven (11) hips due to hematoma or wound complications, less than eleven (11) hips due to wear or osteolysis, less than eleven (11) hips due to pain, less than eleven (11) hips due to periprosthetic fracture, and less than eleven (11) hips due to all other reasons. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2020 and 30-Jun-2025 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand and thirty-seven (1,037) hips underwent revision THA in which a OR3O Dual Mobility Insert or Liner was implanted in United States between 01-Jan-2020 and 30-Jun-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 7.46% (5.95%¿8.96%) vs 7.31% (6.93%¿7.69%) of the class.;- At 2nd postoperative year: 8.70% (6.95%¿10.42%) vs 8.52% (8.11%¿8.94%) of the class.;- At 3rd postoperative year: 9.33% (7.45%¿11.17%) vs 9.14% (8.71%¿9.57%) of the class.;- At 4th postoperative year: 9.80% (7.83%¿11.73%) vs 9.60% (9.15%¿10.05%) of the class.;- At 5th postoperative year: 10.10% (8.07%¿12.08%) vs 9.89% (9.43%¿10.35%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the OR3O Dual Mobility Insert or Liner and the Dual Mobility Aggregate revision THR class, as determined by overlapping 95% confidence intervals at all evaluated postoperative years (years 1 through 5).;Accordingly, the re?revision performance of the OR3O Dual Mobility Insert or Liner is statistically comparable to that of the Dual Mobility Aggregate revision THR class over the reported follow?up period.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317593-1-L1,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Acetabular Augment ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one hundred and twenty-six (126) hips underwent revision THA between 01-Jan-2017 and 04-Nov-2024, using a REDAPT Acetabular Augment. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one hundred and twenty-six (126) hips underwent revision THA in between 01-Jan-2017 and 04-Nov-2024 which a REDAPT Acetabular Augment was implanted. Of these, four (4) hips required re-revision due to the following reasons: one (1) hip due to infection, two (2) due to aseptic loosening, two (2) due to instability, two (2) due to mechanical complications, and two (2) due to pain. Multiple reasons for revision may be listed for a single revision case. ;Timeframe of Registry Data: Implantations conducted between 01-Jan-2017 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one hundred and twenty-six (126) hips underwent revision THA in which a REDAPT Acetabular Augment was implanted in United States between 01-Jan-2017 and 04-Nov-2024. The following reasons for re-revisions were provided, in comparison to the AJRR class:;- Aseptic loosening: 1.6% vs 0.9% of the AJRR class;- Pain: 1.6% vs 1.0% of the AJRR class;- Mechanical complications: 1.6% vs 1.1% of the AJRR class;- Dislocation / instability: 1.6% vs 1.8% of the AJRR class;- Infection: 0.8% vs 2.1% of the AJRR class;- Other / unknown: 0.0% vs 0.1% of the AJRR class;- Periprosthetic fracture / fracture: 0.0% vs 0.1% of the AJRR class;- Hematoma or wound complications: 0.0% vs 0.3% of the AJRR class;- Wear / osteolysis: 0.0% vs 0.3% of the AJRR class;The incidence of re-revision due to aseptic loosening, pain and mechanical complications was higher in the REDAPT Acetabular Augment group compared to the class data. Augments are typically used when there is an acetabular defect, where the remaining host bone provides limited biological and mechanical support for implant fixation. Therefore, the differences outlined in the reasons for revision between the REDAPT Acetabular Augment cases and all other Revision THA cases may be driven by complexity of the revision THAs that are treated with augments. All other reasons for revision had a lower incidence in the REDAPT Acetabular Augment group compared to the class data.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317593-1-L2,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Acetabular Augment ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one hundred and twenty-six (126) hips underwent revision THA between 01-Jan-2017 and 04-Nov-2024, using a REDAPT Acetabular Augment. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one hundred and twenty-six (126) hips underwent revision THA in between 01-Jan-2017 and 04-Nov-2024 which a REDAPT Acetabular Augment was implanted. Of these, four (4) hips required re-revision due to the following reasons: one (1) hip due to infection, two (2) due to aseptic loosening, two (2) due to instability, two (2) due to mechanical complications, and two (2) due to pain. Multiple reasons for revision may be listed for a single revision case. ;Timeframe of Registry Data: Implantations conducted between 01-Jan-2017 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one hundred and twenty-six (126) hips underwent revision THA in which a REDAPT Acetabular Augment was implanted in United States between 01-Jan-2017 and 04-Nov-2024. The following reasons for re-revisions were provided, in comparison to the AJRR class:;- Aseptic loosening: 1.6% vs 0.9% of the AJRR class;- Pain: 1.6% vs 1.0% of the AJRR class;- Mechanical complications: 1.6% vs 1.1% of the AJRR class;- Dislocation / instability: 1.6% vs 1.8% of the AJRR class;- Infection: 0.8% vs 2.1% of the AJRR class;- Other / unknown: 0.0% vs 0.1% of the AJRR class;- Periprosthetic fracture / fracture: 0.0% vs 0.1% of the AJRR class;- Hematoma or wound complications: 0.0% vs 0.3% of the AJRR class;- Wear / osteolysis: 0.0% vs 0.3% of the AJRR class;The incidence of re-revision due to aseptic loosening, pain and mechanical complications was higher in the REDAPT Acetabular Augment group compared to the class data. Augments are typically used when there is an acetabular defect, where the remaining host bone provides limited biological and mechanical support for implant fixation. Therefore, the differences outlined in the reasons for revision between the REDAPT Acetabular Augment cases and all other Revision THA cases may be driven by complexity of the revision THAs that are treated with augments. All other reasons for revision had a lower incidence in the REDAPT Acetabular Augment group compared to the class data.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317593-1-L3,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Acetabular Augment ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one hundred and twenty-six (126) hips underwent revision THA between 01-Jan-2017 and 04-Nov-2024, using a REDAPT Acetabular Augment. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one hundred and twenty-six (126) hips underwent revision THA in between 01-Jan-2017 and 04-Nov-2024 which a REDAPT Acetabular Augment was implanted. Of these, four (4) hips required re-revision due to the following reasons: one (1) hip due to infection, two (2) due to aseptic loosening, two (2) due to instability, two (2) due to mechanical complications, and two (2) due to pain. Multiple reasons for revision may be listed for a single revision case. ;Timeframe of Registry Data: Implantations conducted between 01-Jan-2017 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one hundred and twenty-six (126) hips underwent revision THA in which a REDAPT Acetabular Augment was implanted in United States between 01-Jan-2017 and 04-Nov-2024. The following reasons for re-revisions were provided, in comparison to the AJRR class:;- Aseptic loosening: 1.6% vs 0.9% of the AJRR class;- Pain: 1.6% vs 1.0% of the AJRR class;- Mechanical complications: 1.6% vs 1.1% of the AJRR class;- Dislocation / instability: 1.6% vs 1.8% of the AJRR class;- Infection: 0.8% vs 2.1% of the AJRR class;- Other / unknown: 0.0% vs 0.1% of the AJRR class;- Periprosthetic fracture / fracture: 0.0% vs 0.1% of the AJRR class;- Hematoma or wound complications: 0.0% vs 0.3% of the AJRR class;- Wear / osteolysis: 0.0% vs 0.3% of the AJRR class;The incidence of re-revision due to aseptic loosening, pain and mechanical complications was higher in the REDAPT Acetabular Augment group compared to the class data. Augments are typically used when there is an acetabular defect, where the remaining host bone provides limited biological and mechanical support for implant fixation. Therefore, the differences outlined in the reasons for revision between the REDAPT Acetabular Augment cases and all other Revision THA cases may be driven by complexity of the revision THAs that are treated with augments. All other reasons for revision had a lower incidence in the REDAPT Acetabular Augment group compared to the class data.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317593-1-L4,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Acetabular Augment ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of one hundred and twenty-six (126) hips underwent revision THA between 01-Jan-2017 and 04-Nov-2024, using a REDAPT Acetabular Augment. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one hundred and twenty-six (126) hips underwent revision THA in between 01-Jan-2017 and 04-Nov-2024 which a REDAPT Acetabular Augment was implanted. Of these, four (4) hips required re-revision due to the following reasons: one (1) hip due to infection, two (2) due to aseptic loosening, two (2) due to instability, two (2) due to mechanical complications, and two (2) due to pain. Multiple reasons for revision may be listed for a single revision case. ;Timeframe of Registry Data: Implantations conducted between 01-Jan-2017 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one hundred and twenty-six (126) hips underwent revision THA in which a REDAPT Acetabular Augment was implanted in United States between 01-Jan-2017 and 04-Nov-2024. The following reasons for re-revisions were provided, in comparison to the AJRR class:;- Aseptic loosening: 1.6% vs 0.9% of the AJRR class;- Pain: 1.6% vs 1.0% of the AJRR class;- Mechanical complications: 1.6% vs 1.1% of the AJRR class;- Dislocation / instability: 1.6% vs 1.8% of the AJRR class;- Infection: 0.8% vs 2.1% of the AJRR class;- Other / unknown: 0.0% vs 0.1% of the AJRR class;- Periprosthetic fracture / fracture: 0.0% vs 0.1% of the AJRR class;- Hematoma or wound complications: 0.0% vs 0.3% of the AJRR class;- Wear / osteolysis: 0.0% vs 0.3% of the AJRR class;The incidence of re-revision due to aseptic loosening, pain and mechanical complications was higher in the REDAPT Acetabular Augment group compared to the class data. Augments are typically used when there is an acetabular defect, where the remaining host bone provides limited biological and mechanical support for implant fixation. Therefore, the differences outlined in the reasons for revision between the REDAPT Acetabular Augment cases and all other Revision THA cases may be driven by complexity of the revision THAs that are treated with augments. All other reasons for revision had a lower incidence in the REDAPT Acetabular Augment group compared to the class data.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L1,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L2,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L3,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L4,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L5,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L6,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L7,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L8,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L9,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L10,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L11,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L12,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L13,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L14,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L15,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L16,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L17,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L18,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L19,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L20,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L21,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L22,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L23,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L24,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L25,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L26,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L27,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L28,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L29,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L30,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L31,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L32,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L33,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L34,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L35,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L36,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L37,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L38,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L39,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L40,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317604-1-L41,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Modular Acetabular Shell ,,,,,,K211176,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024, using a REDAPT Modular Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA between 01-Jan-2012 and 16-Aug-2024 in which a REDAPT Modular Acetabular Shell was implanted. Of these, forty-one (41) hips required re-revision due to the following reasons: ten (10) hips due to fracture, twelve (12) due to infection, fifteen (15) due to aseptic loosening, twenty four (24) due to instability, ten (10) due to mechanical complications, eight (8) due to hematoma or wound complications, three (3) due to wear or osteolysis, ten (10) due to pain, and three (3) due to periprosthetic fracture.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2012 and 16-Aug-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand two hundred and ninety-nine (1,299) hips underwent revision THA in which a REDAPT Modular Acetabular Shell was implanted in United States between 01-Jan-2012 and 16-Aug-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st postoperative year: 2.82% (1.97%¿3.67%) vs 4.74% (4.63%¿4.86%) of the class.; - At 2nd postoperative year: 3.34% (2.33%¿4.33%) vs 5.60% (5.47%¿5.73%) of the class.; - At 3rd postoperative year: 3.70% (2.58%¿4.80%) vs 6.20% (6.06%¿6.34%) of the class.; - At 4th postoperative year: 3.98% (2.78%¿5.16%) vs 6.66% (6.51%¿6.81%) of the class.; - At 5th postoperative year: 4.19% (2.93%¿5.43%) vs 7.01% (6.85%¿7.16%) of the class.; - At 6th postoperative year: 4.35% (3.04%¿5.64%) vs 7.27% (7.11%¿7.43%) of the class.;By observing the cumulative re-revision rates above, it can be determined that there is a statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class at all reported postoperative years, as determined by non-overlapping 95% confidence intervals Across years 1 through 6, with the re-revision rates for REDAPT being consistently and significantly lower than those of the revision THR class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,67,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317738-1-L1,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Porous Acetabular Shell ,,,,,,K150790,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024, using a REDAPT Porous Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024 in which a REDAPT Porous Acetabular Shell was implanted. Of these, nine (9) hips required re-revision due to the following reasons: three (3) hips due to fracture, three (3) hips due to infection, five (5) hips due to aseptic loosening, four (4) hips due to instability, one (1) hip due to mechanical complications, one (1) hip due to wear or osteolysis, two (2) hips due to pain, and one (1) hip due to periprosthetic fracture. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2016 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-one (221) hips underwent revision THA in which a REDAPT Porous Acetabular Shell was implanted in United States between 01-Jan-2016 and 04-Nov-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 1.83% (0.69%¿4.80%) vs 4.64% (4.50%¿4.78%) of the class.;? At 2nd postoperative year: 2.44% (1.01%¿5.79%) vs 5.39% (5.24%¿5.55%) of the class.;? At 3rd postoperative year: 4.57% (2.28%¿9.08%) vs 5.84% (5.68%¿6.00%) of the class.;? At 4th postoperative year: 5.30% (2.75%¿10.09%) vs 6.14% (5.97%¿6.31%) of the class.;? At 5th postoperative year: 5.30% (2.75%¿10.09%) vs 6.29% (6.12%¿6.47%) of the class.;? At 6th postoperative year: 5.30% (2.75%¿10.09%) vs 6.34% (6.17%¿6.52%) of the class.;? At 7th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;? At 8th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the REDAPT Porous Acetabular Shell and the revision THR class, as determined by overlapping 95% confidence intervals at all reported postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317738-1-L2,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Porous Acetabular Shell ,,,,,,K150790,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024, using a REDAPT Porous Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024 in which a REDAPT Porous Acetabular Shell was implanted. Of these, nine (9) hips required re-revision due to the following reasons: three (3) hips due to fracture, three (3) hips due to infection, five (5) hips due to aseptic loosening, four (4) hips due to instability, one (1) hip due to mechanical complications, one (1) hip due to wear or osteolysis, two (2) hips due to pain, and one (1) hip due to periprosthetic fracture. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2016 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-one (221) hips underwent revision THA in which a REDAPT Porous Acetabular Shell was implanted in United States between 01-Jan-2016 and 04-Nov-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 1.83% (0.69%¿4.80%) vs 4.64% (4.50%¿4.78%) of the class.;? At 2nd postoperative year: 2.44% (1.01%¿5.79%) vs 5.39% (5.24%¿5.55%) of the class.;? At 3rd postoperative year: 4.57% (2.28%¿9.08%) vs 5.84% (5.68%¿6.00%) of the class.;? At 4th postoperative year: 5.30% (2.75%¿10.09%) vs 6.14% (5.97%¿6.31%) of the class.;? At 5th postoperative year: 5.30% (2.75%¿10.09%) vs 6.29% (6.12%¿6.47%) of the class.;? At 6th postoperative year: 5.30% (2.75%¿10.09%) vs 6.34% (6.17%¿6.52%) of the class.;? At 7th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;? At 8th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the REDAPT Porous Acetabular Shell and the revision THR class, as determined by overlapping 95% confidence intervals at all reported postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317738-1-L3,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Porous Acetabular Shell ,,,,,,K150790,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024, using a REDAPT Porous Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024 in which a REDAPT Porous Acetabular Shell was implanted. Of these, nine (9) hips required re-revision due to the following reasons: three (3) hips due to fracture, three (3) hips due to infection, five (5) hips due to aseptic loosening, four (4) hips due to instability, one (1) hip due to mechanical complications, one (1) hip due to wear or osteolysis, two (2) hips due to pain, and one (1) hip due to periprosthetic fracture. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2016 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-one (221) hips underwent revision THA in which a REDAPT Porous Acetabular Shell was implanted in United States between 01-Jan-2016 and 04-Nov-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 1.83% (0.69%¿4.80%) vs 4.64% (4.50%¿4.78%) of the class.;? At 2nd postoperative year: 2.44% (1.01%¿5.79%) vs 5.39% (5.24%¿5.55%) of the class.;? At 3rd postoperative year: 4.57% (2.28%¿9.08%) vs 5.84% (5.68%¿6.00%) of the class.;? At 4th postoperative year: 5.30% (2.75%¿10.09%) vs 6.14% (5.97%¿6.31%) of the class.;? At 5th postoperative year: 5.30% (2.75%¿10.09%) vs 6.29% (6.12%¿6.47%) of the class.;? At 6th postoperative year: 5.30% (2.75%¿10.09%) vs 6.34% (6.17%¿6.52%) of the class.;? At 7th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;? At 8th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the REDAPT Porous Acetabular Shell and the revision THR class, as determined by overlapping 95% confidence intervals at all reported postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317738-1-L4,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Porous Acetabular Shell ,,,,,,K150790,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024, using a REDAPT Porous Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024 in which a REDAPT Porous Acetabular Shell was implanted. Of these, nine (9) hips required re-revision due to the following reasons: three (3) hips due to fracture, three (3) hips due to infection, five (5) hips due to aseptic loosening, four (4) hips due to instability, one (1) hip due to mechanical complications, one (1) hip due to wear or osteolysis, two (2) hips due to pain, and one (1) hip due to periprosthetic fracture. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2016 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-one (221) hips underwent revision THA in which a REDAPT Porous Acetabular Shell was implanted in United States between 01-Jan-2016 and 04-Nov-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 1.83% (0.69%¿4.80%) vs 4.64% (4.50%¿4.78%) of the class.;? At 2nd postoperative year: 2.44% (1.01%¿5.79%) vs 5.39% (5.24%¿5.55%) of the class.;? At 3rd postoperative year: 4.57% (2.28%¿9.08%) vs 5.84% (5.68%¿6.00%) of the class.;? At 4th postoperative year: 5.30% (2.75%¿10.09%) vs 6.14% (5.97%¿6.31%) of the class.;? At 5th postoperative year: 5.30% (2.75%¿10.09%) vs 6.29% (6.12%¿6.47%) of the class.;? At 6th postoperative year: 5.30% (2.75%¿10.09%) vs 6.34% (6.17%¿6.52%) of the class.;? At 7th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;? At 8th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the REDAPT Porous Acetabular Shell and the revision THR class, as determined by overlapping 95% confidence intervals at all reported postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317738-1-L5,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Porous Acetabular Shell ,,,,,,K150790,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024, using a REDAPT Porous Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024 in which a REDAPT Porous Acetabular Shell was implanted. Of these, nine (9) hips required re-revision due to the following reasons: three (3) hips due to fracture, three (3) hips due to infection, five (5) hips due to aseptic loosening, four (4) hips due to instability, one (1) hip due to mechanical complications, one (1) hip due to wear or osteolysis, two (2) hips due to pain, and one (1) hip due to periprosthetic fracture. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2016 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-one (221) hips underwent revision THA in which a REDAPT Porous Acetabular Shell was implanted in United States between 01-Jan-2016 and 04-Nov-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 1.83% (0.69%¿4.80%) vs 4.64% (4.50%¿4.78%) of the class.;? At 2nd postoperative year: 2.44% (1.01%¿5.79%) vs 5.39% (5.24%¿5.55%) of the class.;? At 3rd postoperative year: 4.57% (2.28%¿9.08%) vs 5.84% (5.68%¿6.00%) of the class.;? At 4th postoperative year: 5.30% (2.75%¿10.09%) vs 6.14% (5.97%¿6.31%) of the class.;? At 5th postoperative year: 5.30% (2.75%¿10.09%) vs 6.29% (6.12%¿6.47%) of the class.;? At 6th postoperative year: 5.30% (2.75%¿10.09%) vs 6.34% (6.17%¿6.52%) of the class.;? At 7th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;? At 8th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the REDAPT Porous Acetabular Shell and the revision THR class, as determined by overlapping 95% confidence intervals at all reported postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317738-1-L6,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Porous Acetabular Shell ,,,,,,K150790,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024, using a REDAPT Porous Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024 in which a REDAPT Porous Acetabular Shell was implanted. Of these, nine (9) hips required re-revision due to the following reasons: three (3) hips due to fracture, three (3) hips due to infection, five (5) hips due to aseptic loosening, four (4) hips due to instability, one (1) hip due to mechanical complications, one (1) hip due to wear or osteolysis, two (2) hips due to pain, and one (1) hip due to periprosthetic fracture. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2016 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-one (221) hips underwent revision THA in which a REDAPT Porous Acetabular Shell was implanted in United States between 01-Jan-2016 and 04-Nov-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 1.83% (0.69%¿4.80%) vs 4.64% (4.50%¿4.78%) of the class.;? At 2nd postoperative year: 2.44% (1.01%¿5.79%) vs 5.39% (5.24%¿5.55%) of the class.;? At 3rd postoperative year: 4.57% (2.28%¿9.08%) vs 5.84% (5.68%¿6.00%) of the class.;? At 4th postoperative year: 5.30% (2.75%¿10.09%) vs 6.14% (5.97%¿6.31%) of the class.;? At 5th postoperative year: 5.30% (2.75%¿10.09%) vs 6.29% (6.12%¿6.47%) of the class.;? At 6th postoperative year: 5.30% (2.75%¿10.09%) vs 6.34% (6.17%¿6.52%) of the class.;? At 7th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;? At 8th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the REDAPT Porous Acetabular Shell and the revision THR class, as determined by overlapping 95% confidence intervals at all reported postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317738-1-L7,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Porous Acetabular Shell ,,,,,,K150790,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024, using a REDAPT Porous Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024 in which a REDAPT Porous Acetabular Shell was implanted. Of these, nine (9) hips required re-revision due to the following reasons: three (3) hips due to fracture, three (3) hips due to infection, five (5) hips due to aseptic loosening, four (4) hips due to instability, one (1) hip due to mechanical complications, one (1) hip due to wear or osteolysis, two (2) hips due to pain, and one (1) hip due to periprosthetic fracture. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2016 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-one (221) hips underwent revision THA in which a REDAPT Porous Acetabular Shell was implanted in United States between 01-Jan-2016 and 04-Nov-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 1.83% (0.69%¿4.80%) vs 4.64% (4.50%¿4.78%) of the class.;? At 2nd postoperative year: 2.44% (1.01%¿5.79%) vs 5.39% (5.24%¿5.55%) of the class.;? At 3rd postoperative year: 4.57% (2.28%¿9.08%) vs 5.84% (5.68%¿6.00%) of the class.;? At 4th postoperative year: 5.30% (2.75%¿10.09%) vs 6.14% (5.97%¿6.31%) of the class.;? At 5th postoperative year: 5.30% (2.75%¿10.09%) vs 6.29% (6.12%¿6.47%) of the class.;? At 6th postoperative year: 5.30% (2.75%¿10.09%) vs 6.34% (6.17%¿6.52%) of the class.;? At 7th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;? At 8th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the REDAPT Porous Acetabular Shell and the revision THR class, as determined by overlapping 95% confidence intervals at all reported postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317738-1-L8,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Porous Acetabular Shell ,,,,,,K150790,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024, using a REDAPT Porous Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024 in which a REDAPT Porous Acetabular Shell was implanted. Of these, nine (9) hips required re-revision due to the following reasons: three (3) hips due to fracture, three (3) hips due to infection, five (5) hips due to aseptic loosening, four (4) hips due to instability, one (1) hip due to mechanical complications, one (1) hip due to wear or osteolysis, two (2) hips due to pain, and one (1) hip due to periprosthetic fracture. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2016 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-one (221) hips underwent revision THA in which a REDAPT Porous Acetabular Shell was implanted in United States between 01-Jan-2016 and 04-Nov-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 1.83% (0.69%¿4.80%) vs 4.64% (4.50%¿4.78%) of the class.;? At 2nd postoperative year: 2.44% (1.01%¿5.79%) vs 5.39% (5.24%¿5.55%) of the class.;? At 3rd postoperative year: 4.57% (2.28%¿9.08%) vs 5.84% (5.68%¿6.00%) of the class.;? At 4th postoperative year: 5.30% (2.75%¿10.09%) vs 6.14% (5.97%¿6.31%) of the class.;? At 5th postoperative year: 5.30% (2.75%¿10.09%) vs 6.29% (6.12%¿6.47%) of the class.;? At 6th postoperative year: 5.30% (2.75%¿10.09%) vs 6.34% (6.17%¿6.52%) of the class.;? At 7th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;? At 8th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the REDAPT Porous Acetabular Shell and the revision THR class, as determined by overlapping 95% confidence intervals at all reported postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00317738-1-L9,,4/27/2026,3/13/2026,REDAPT REVISION ACETABULAR SYSTEM,REDAPT Porous Acetabular Shell ,,,,,,K150790,,IN,"It was reported that, in the American Joint Replacement Registry (AJRR) from the United States, a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024, using a REDAPT Porous Acetabular Shell. Of these, one (1) hip was re-revised due to unknown reasons. Based on the stratification used by AJRR, no specific reason for revision can be definitively linked to the individual component reported through this line item.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the American Joint Replacement Registry (AJRR), a total of two hundred and twenty-one (221) hips underwent revision THA between 01-Jan-2016 and 04-Nov-2024 in which a REDAPT Porous Acetabular Shell was implanted. Of these, nine (9) hips required re-revision due to the following reasons: three (3) hips due to fracture, three (3) hips due to infection, five (5) hips due to aseptic loosening, four (4) hips due to instability, one (1) hip due to mechanical complications, one (1) hip due to wear or osteolysis, two (2) hips due to pain, and one (1) hip due to periprosthetic fracture. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2016 and 04-Nov-2024 in United States;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and twenty-one (221) hips underwent revision THA in which a REDAPT Porous Acetabular Shell was implanted in United States between 01-Jan-2016 and 04-Nov-2024. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st postoperative year: 1.83% (0.69%¿4.80%) vs 4.64% (4.50%¿4.78%) of the class.;? At 2nd postoperative year: 2.44% (1.01%¿5.79%) vs 5.39% (5.24%¿5.55%) of the class.;? At 3rd postoperative year: 4.57% (2.28%¿9.08%) vs 5.84% (5.68%¿6.00%) of the class.;? At 4th postoperative year: 5.30% (2.75%¿10.09%) vs 6.14% (5.97%¿6.31%) of the class.;? At 5th postoperative year: 5.30% (2.75%¿10.09%) vs 6.29% (6.12%¿6.47%) of the class.;? At 6th postoperative year: 5.30% (2.75%¿10.09%) vs 6.34% (6.17%¿6.52%) of the class.;? At 7th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;? At 8th postoperative year: 5.30% (2.75%¿10.09%) vs 6.35% (6.17%¿6.52%) of the class.;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the REDAPT Porous Acetabular Shell and the revision THR class, as determined by overlapping 95% confidence intervals at all reported postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. 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.",,68,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE AMERICAN JOINT REPLACEMENT REGISTRY (AJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE UNITED STATES FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY JOINT REPLACEMENT PROCEDURES: 1. PRIMARY THA PROCEDURES: OR3O LINER-INSERT COMPONENT + R3 SHELL: A TOTAL OF FIVE THOUSAND AND THIRTY-TWO (5,032) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 1-JAN-2020 AND 30-JUN-2025. FROM THESE, ONE HUNDRED AND SEVENTEEN (117) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: THIRTY-NINE (39) HIPS DUE TO INFECTION, SIXTEEN (16) HIPS DUE TO ASEPTIC LOOSENING, THIRTY-FOUR (34) HIPS DUE TO FRACTURE , TWENTY-EIGHT (28) HIPS DUE TO DISLOCATIONS, LESS THAN ELEVEN (11) HIPS DUE TO HEMATOMA OR UNSPECIFIED WOUND COMPLICATIONS, LESS THAN ELEVEN (11) HIPS DUE TO INSTABILITY, SIXTEEN (16) HIPS DUE TO UNSPECIFIED MECHANICAL COMPLICATIONS, TWENTY-SEVEN (27) HIPS DUE TO PERIPROSTHETIC FRACTURE, EIGHTEEN (18) HIPS DUE TO UNSPECIFIED PAIN, LESS THAN ELEVEN (11) HIPS DUE TO WEAR OR OSTEOLYSIS AND LESS THAN ELEVEN (11) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY. IN ADDITION, THE AJRR REPORT DOES NOT PROVIDE AN EXACT NUMBER OF REVISIONS FOR THOSE REASONS ACCOUNTING FOR LESS THAN 11 CASES. ALTOGETHER, A TOTAL QUANTITY OF AT LEAST 117 REVISIONS HAVE BEEN REPORTED IN THE AJRR FOR THE OR3O LINER-INSERT COMPONENT WITH AN R3 SHELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
112847		PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	LPH	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR	Unknown

Terms

Patient problem · 12

• Aseptic loosening
• Bone Fracture(s)
• Erosion
• Hematoma
• Impaired Healing
• Insufficient Information
• Joint Dislocation
• Joint Laxity
• Osteolysis
• Pain
• Periprosthetic fracture
• Unspecified Infection

Product problems · 4

• Adverse Event Without Identified Device or Use Problem
• Fracture
• Material Erosion
• Osseointegration Problem

Source type · 1

• Other

Type of report · 2

• Followup
• Initial submission