BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    REFLECTION CONSTRAINED ACETABULAR LINER

    MDR report key: 22164515 · Received June 8, 2025

    Report

    Report Number
    1020279-2025-01033
    Event Type
    Injury
    Date Received
    June 8, 2025
    Report Date
    October 24, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025). SUMMARY OF ADVERSE EVENTS: IT WAS REPORTED THAT, IN THE NATIONAL JOINT REGISTRY (NJR) FROM THE UNITED KINGDOM, A TOTAL OF TWENTY-SIX (26) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 01-JAN-2004 AND 31-DEC-2013, USING A REFLECTION CONSTRAINED LINER. FROM THESE, FIVE (5) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: TWO (2) HIPS DUE TO DISLOCATION/SUBLUXATION, ONE (1) HIP DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO IMPLANT FRACTURE ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO INFECTION, ONE (1) HIP DUE TO PAIN AND ONE (1) HIP DUE TO OTHER/UNKNOWN REASONS. IT SHOULD BE NOTED THAT MORE THAN ONE REASON FOR REVISION MAY BE ASSOCIATED WITH A REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE. TIMEFRAME OF REGISTRY DATA: IMPLANTATIONS CONDUCTED BETWEEN 01-JAN-2004 AND 31-DEC-2013 IN THE UNITED KINGDOM. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE REFLECTION ACETABULAR SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. ACCORDING TO THIS REGISTRY REPORT, A TOTAL OF TWENTY-SIX (26) REVISION THA PROCEDURES WITH REFLECTION CONSTRAINED LINERS HAVE BEEN PERFORMED IN THE UNITED KINGDOM BETWEEN 01-JAN-2004 AND 31-DEC-2013. THE MEAN CUMULATIVE RE-REVISION RATES FOR THE REFLECTION CONSTRAINED LINERS WERE HIGHER THAN THE MEAN CUMULATIVE RE-REVISION RATES FOR THE NJR CEMENTLESS REVISION THA CLASS REPORTED IN THE NJR 21ST ANNUAL REPORT 2024 (TABLE 3H16(C)) AT FIRST FOLLOW UP YEAR, AS SHOWN BY NON-OVERLAPPING CONFIDENCE INTERVALS. FROM THE 3RD FOLLOW UP YEAR ONWARDS, THE RE-REVISION RATES WERE IN LINE WITH THE NJR CEMENTLESS REVISION THA CLASS AS SHOWN BY OVERLAPPING CONFIDENCE INTERVALS. NONETHELESS, DUE TO LOW QUANTITY OF USES (N=26), NO RELEVANT CONCLUSIONS COULD BE ESTABLISHED FROM THIS ANALYSIS. THE FOLLOWING CUMULATIVE RE-REVISION RATES WITH 95% CONFIDENCE INTERVALS ARE PRESENTED IN THIS REPORT: O AT 1ST POSTOPERATIVE YEAR: 15.87% (6.27%-36.95%) VS 5.53% (5.22%-5.86%) OF THE CLASS. O AT 3RD POSTOPERATIVE YEAR: 15.87% (6.27%-36.95%) VS 9.65% (9.23%-10.09%) OF THE CLASS. O AT 5TH POSTOPERATIVE YEAR: 15.87% (6.27%-36.95%) VS 11.72% (11.25%-12.21%) OF THE CLASS. O AT 7TH POSTOPERATIVE YEAR: 15.87% (6.27%-36.95%) VS 13.41% (12.89%-13.95%) OF THE CLASS. O AT 10TH POSTOPERATIVE YEAR: 15.87% (6.27%-36.95%) VS 15.27% (14.68%-15.89%) OF THE CLASS. O AT 13TH POSTOPERATIVE YEAR: 26.38% (10.47%-57.19%) VS 17.38% (16.60%-18.20%) OF THE CLASS. O AT 15TH POSTOPERATIVE YEAR: 26.38% (10.47%-57.19%) VS 19.29% (18.09%-20.55%) OF THE CLASS. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5 (EVENT NARRATIVE). H11: THIS REPORT IS SUBMITTED IN RESPONSE TO THE FDA¿S OBSERVATIONS REGARDING SMITH+NEPHEW¿S (S+N) SUMMARY MDR REPORTING PRACTICES UNDER RWD2300584, COMMUNICATED ON (B)(6) 2025. AS A RESULT, THE MDR WITH REFERENCE 1020279-2025-01033 INCORPORATES ALL THE REAL WORD DATA SHARING THE FOLLOWING BUNDLING CRITERIA: REGISTRATION NUMBER: (B)(4), DATA SOURCE: NATIONAL JOINT REGISTRY (NJR), REPORT TYPE: SERIOUS INJURY, PRODUCT CLASSIFICATION CODE: KWZ. NO ADDITIONAL COMPLAINTS HAVE BEEN ADDED SINCE THE LAST SUBMISSION MADE ON (B)(6) 2025. EXCEPT FOR THE CORRECTED FIELD NOTED ABOVE UNDER ¿CORRECTED DATA¿, THE INFORMATION PROVIDED IN THE REQUIRED FIELDS OF THE PRIOR 3500A FORM SUBMITTED ON 08-JUN-2025 REMAINS UNCHANGED. REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN REVISION JOINT REPLACEMENT PROCEDURES: 1. REVISION THA PROCEDURES: - REFLECTION CONSTRAINED LINER COMPONENTS: IMPLANTED IN TWENTY-SIX (26) HIPS BETWEEN (B)(6) 2004 AND (B)(6) 2013. FROM THESE, FIVE (5) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: TWO (2) HIPS DUE TO DISLOCATION/SUBLUXATION, ONE (1) HIP DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO IMPLANT FRACTURE ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO INFECTION, ONE (1) HIP DUE TO PAIN AND ONE (1) HIP DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE REFLECTION ACETABULAR SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICE. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL THEIR THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. NJR MONTHLY DATA DOWNLOAD COMPRISING REVISION THAS IMPLANTED WITH REFLECTION CONSTRAINED LINER COMPONENTS WAS ANALYZED. THE MEAN CUMULATIVE RE-REVISION RATES WERE HIGHER THAN THE MEAN CUMULATIVE RE-REVISION RATES FOR THE NJR CEMENTLESS REVISION THA CLASS REPORTED IN THE NJR 21ST ANNUAL REPORT 2024 AT FIRST FOLLOW UP YEAR, AS SHOWN BY NON-OVERLAPPING CONFIDENCE INTERVALS. FROM THE 3RD FOLLOW UP YEAR ONWARDS, THE RE-REVISION RATES WERE IN LINE WITH THE NJR CEMENTLESS REVISION THA CLASS AS SHOWN BY OVERLAPPING CONFIDENCE INTERVALS. NONETHELESS, DUE TO LOW QUANTITY OF USES (N=26), NO RELEVANT CONCLUSIONS COULD BE ESTABLISHED. SPECIFIC ANALYSIS IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

    Description of Event or Problem · 0

    Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00269429-1-L1,4/27/2020,6/8/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION CONSTRAINED LINER 0 DEGREE 28MM INNER DIAMETER 54-56MM OUTER DIAMETER SIZE F,71323125,04JM16322,71323125,,03596010480057,K021803,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of twenty-six (26) hips underwent revision THA procedures between 16-Apr-2004 and 12-Jul-2013, using a REFLECTION Constrained Liner. From these, one (1) hip was later re-revised due to: Lysis of the Socket, Malalignment of the Socket, Dislocation/Subluxation and Unexplained Pain","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of twenty-six (26) hips underwent revision THA procedures between 16-Apr-2004 and 12-Jul-2013, using a REFLECTION Constrained Liner. From these, five (5) hips were later re-revised due to the following reasons: Two (2) hips due to dislocation/subluxation, one (1) hip due to aseptic loosening associated with the socket, one (1) hip due to implant fracture associated with the socket, one (1) hip due to infection, one (1) hip due to pain and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-Apr-2004 and 12-Jul-2013 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty-six (26) revision THA procedures with REFLECTION Constrained liners have been performed in the United Kingdom between 16-Apr-2004 and 12-Jul-2013. The mean cumulative re-revision rates for the REFLECTION Constrained liners were higher than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) at first follow up year, as shown by non-overlapping confidence intervals. From the 3rd follow up year onwards, the re-revision rates were in line with the NJR Cementless revision THA class as shown by overlapping confidence intervals. Nonetheless, due to low quantity of uses (n=26), no relevant conclusions could be established from this analysis. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 15.87% (6.27%-36.95%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 15.87% (6.27%-36.95%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 15.87% (6.27%-36.95%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 15.87% (6.27%-36.95%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 15.87% (6.27%-36.95%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 26.38% (10.47%-57.19%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 26.38% (10.47%-57.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,79,Female,67,3/9/2009,4/27/2020,E161201;E2308;E1614;E2330,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269429-1-L2,8/12/2009,6/8/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION CONSTRAINED LINER 0 DEG 26 INNER DIAMETER 50-52 OUTER DIAMETER SIZE E,71323114,05CM06047,71323114,,03596010510884,K033442,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of twenty-six (26) hips underwent revision THA procedures between 16-Apr-2004 and 12-Jul-2013, using a REFLECTION Constrained Liner. From these, one (1) hip was later re-revised due to: Other - unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of twenty-six (26) hips underwent revision THA procedures between 16-Apr-2004 and 12-Jul-2013, using a REFLECTION Constrained Liner. From these, five (5) hips were later re-revised due to the following reasons: Two (2) hips due to dislocation/subluxation, one (1) hip due to aseptic loosening associated with the socket, one (1) hip due to implant fracture associated with the socket, one (1) hip due to infection, one (1) hip due to pain and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-Apr-2004 and 12-Jul-2013 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty-six (26) revision THA procedures with REFLECTION Constrained liners have been performed in the United Kingdom between 16-Apr-2004 and 12-Jul-2013. The mean cumulative re-revision rates for the REFLECTION Constrained liners were higher than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) at first follow up year, as shown by non-overlapping confidence intervals. From the 3rd follow up year onwards, the re-revision rates were in line with the NJR Cementless revision THA class as shown by overlapping confidence intervals. Nonetheless, due to low quantity of uses (n=26), no relevant conclusions could be established from this analysis. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 15.87% (6.27%-36.95%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 15.87% (6.27%-36.95%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 15.87% (6.27%-36.95%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 15.87% (6.27%-36.95%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 15.87% (6.27%-36.95%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 26.38% (10.47%-57.19%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 26.38% (10.47%-57.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,63,Female,127,7/15/2009,8/12/2009,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269429-1-L3,11/18/2009,6/8/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION CONSTRAINED LINER 0 DEGREE 28MM INNER DIAMETER 58-60MM OUTER DIAMETER SIZE G,71323126,04JM16327,71323126,,03596010480071,K021803,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of twenty-six (26) hips underwent revision THA procedures between 16-Apr-2004 and 12-Jul-2013, using a REFLECTION Constrained Liner. From these, one (1) hip was later re-revised due to: Loosening of the stem, Loosening of the socket","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of twenty-six (26) hips underwent revision THA procedures between 16-Apr-2004 and 12-Jul-2013, using a REFLECTION Constrained Liner. From these, five (5) hips were later re-revised due to the following reasons: Two (2) hips due to dislocation/subluxation, one (1) hip due to aseptic loosening associated with the socket, one (1) hip due to implant fracture associated with the socket, one (1) hip due to infection, one (1) hip due to pain and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-Apr-2004 and 12-Jul-2013 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty-six (26) revision THA procedures with REFLECTION Constrained liners have been performed in the United Kingdom between 16-Apr-2004 and 12-Jul-2013. The mean cumulative re-revision rates for the REFLECTION Constrained liners were higher than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) at first follow up year, as shown by non-overlapping confidence intervals. From the 3rd follow up year onwards, the re-revision rates were in line with the NJR Cementless revision THA class as shown by overlapping confidence intervals. Nonetheless, due to low quantity of uses (n=26), no relevant conclusions could be established from this analysis. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 15.87% (6.27%-36.95%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 15.87% (6.27%-36.95%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 15.87% (6.27%-36.95%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 15.87% (6.27%-36.95%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 15.87% (6.27%-36.95%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 26.38% (10.47%-57.19%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 26.38% (10.47%-57.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,78,Male,,7/24/2009,11/18/2009,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269429-1-L4,10/29/2012,6/8/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION CONSTRAINED LINER 0 DEGREE 32MM INNER DIAMETER 62-64MM OUTER DIAMETER SIZE H,71323137,04km06721,71323137,,03596010550057,K033442,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of twenty-six (26) hips underwent revision THA procedures between 16-Apr-2004 and 12-Jul-2013, using a REFLECTION Constrained Liner. From these, one (1) hip was later re-revised due to: Unexplained Pain and other-unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of twenty-six (26) hips underwent revision THA procedures between 16-Apr-2004 and 12-Jul-2013, using a REFLECTION Constrained Liner. From these, five (5) hips were later re-revised due to the following reasons: Two (2) hips due to dislocation/subluxation, one (1) hip due to aseptic loosening associated with the socket, one (1) hip due to implant fracture associated with the socket, one (1) hip due to infection, one (1) hip due to pain and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-Apr-2004 and 12-Jul-2013 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty-six (26) revision THA procedures with REFLECTION Constrained liners have been performed in the United Kingdom between 16-Apr-2004 and 12-Jul-2013. The mean cumulative re-revision rates for the REFLECTION Constrained liners were higher than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) at first follow up year, as shown by non-overlapping confidence intervals. From the 3rd follow up year onwards, the re-revision rates were in line with the NJR Cementless revision THA class as shown by overlapping confidence intervals. Nonetheless, due to low quantity of uses (n=26), no relevant conclusions could be established from this analysis. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 15.87% (6.27%-36.95%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 15.87% (6.27%-36.95%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 15.87% (6.27%-36.95%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 15.87% (6.27%-36.95%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 15.87% (6.27%-36.95%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 26.38% (10.47%-57.19%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 26.38% (10.47%-57.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,60,Male,104,6/18/2012,10/29/2012,E2330;E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00269429-1-L5,6/27/2014,6/8/2025,6/2/2025,REFLECTION Acetabular System,REFLECTION CONSTRAINED LINER 0 DEGREE 28MM INNER DIAMETER 54-56MM OUTER DIAMETER SIZE F,71323125,11CM04792,71323125,,03596010480057,K021803,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of twenty-six (26) hips underwent revision THA procedures between 16-Apr-2004 and 12-Jul-2013, using a REFLECTION Constrained Liner. From these, one (1) hip was later re-revised due to: Dislocation/Subluxation","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of twenty-six (26) hips underwent revision THA procedures between 16-Apr-2004 and 12-Jul-2013, using a REFLECTION Constrained Liner. From these, five (5) hips were later re-revised due to the following reasons: Two (2) hips due to dislocation/subluxation, one (1) hip due to aseptic loosening associated with the socket, one (1) hip due to implant fracture associated with the socket, one (1) hip due to infection, one (1) hip due to pain and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-Apr-2004 and 12-Jul-2013 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty-six (26) revision THA procedures with REFLECTION Constrained liners have been performed in the United Kingdom between 16-Apr-2004 and 12-Jul-2013. The mean cumulative re-revision rates for the REFLECTION Constrained liners were higher than the mean cumulative re-revision rates for the NJR Cementless revision THA class reported in the NJR 21st Annual Report 2024 (table 3H16(c)) at first follow up year, as shown by non-overlapping confidence intervals. From the 3rd follow up year onwards, the re-revision rates were in line with the NJR Cementless revision THA class as shown by overlapping confidence intervals. Nonetheless, due to low quantity of uses (n=26), no relevant conclusions could be established from this analysis. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 15.87% (6.27%-36.95%) vs 5.53% (5.22%-5.86%) of the class.;o At 3rd postoperative year: 15.87% (6.27%-36.95%) vs 9.65% (9.23%-10.09%) of the class.;o At 5th postoperative year: 15.87% (6.27%-36.95%) vs 11.72% (11.25%-12.21%) of the class.;o At 7th postoperative year: 15.87% (6.27%-36.95%) vs 13.41% (12.89%-13.95%) of the class.;o At 10th postoperative year: 15.87% (6.27%-36.95%) vs 15.27% (14.68%-15.89%) of the class.;o At 13th postoperative year: 26.38% (10.47%-57.19%) vs 17.38% (16.60%-18.20%) of the class.;o At 15th postoperative year: 26.38% (10.47%-57.19%) vs 19.29% (18.09%-20.55%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,74,Female,,7/12/2013,6/27/2014,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, IN THE NATIONAL JOINT REGISTRY (NJR) FROM THE UNITED KINGDOM, A TOTAL OF TWENTY-SIX (26) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 01-JAN-2004 AND 31-DEC-2013, USING A REFLECTION CONSTRAINED LINER. FROM THESE, FIVE (5) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: TWO (2) HIPS DUE TO DISLOCATION/SUBLUXATION, ONE (1) HIP DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO IMPLANT FRACTURE ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO INFECTION, ONE (1) HIP DUE TO PAIN AND ONE (1) HIP DUE TO OTHER/UNKNOWN REASONS. IT SHOULD BE NOTED THAT MORE THAN ONE REASON FOR REVISION MAY BE ASSOCIATED WITH A REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE. TIMEFRAME OF REGISTRY DATA: IMPLANTATIONS CONDUCTED BETWEEN 01-JAN-2004 AND 31-DEC-2013 IN THE UNITED KINGDOM.

    Description of Event or Problem · 0

    BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN REVISION JOINT REPLACEMENT PROCEDURES: 1. REVISION THA PROCEDURES: - REFLECTION CONSTRAINED LINER COMPONENTS: IMPLANTED IN TWENTY-SIX (26) HIPS BETWEEN (B)(6) 2004 AND (B)(6) 2013. FROM THESE, FIVE (5) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: TWO (2) HIPS DUE TO DISLOCATION/SUBLUXATION, ONE (1) HIP DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO IMPLANT FRACTURE ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO INFECTION, ONE (1) HIP DUE TO PAIN AND ONE (1) HIP DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620069 REFLECTION CONSTRAINED ACETABULAR LINER PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER KWZ SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Required Intervention