PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Report
- Report Number
- 1020279-2025-01706
- Event Type
- Injury
- Date Received
- October 15, 2025
- Report Date
- October 28, 2025
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- MEH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
H11: THIS 3500A FORM IS BEING SUBMITTED AS A CORRECTION TO FOLLOW-UP REPORT 1020279-2025-01706, PREVIOUSLY SUBMITTED ON 14-OCT-2025. SPECIFICALLY, THE 'UDI NUMBER' FIELDS IN CSV FILE HAVE BEEN UPDATED FOR THE LINE ITEMS LABELED AS 'VERSION 1' IN COLUMN AE ('LATEST LINE ITEM VERSION'). THESE UPDATES APPLY TO THE FOLLOWING COMPLAINTS AND REPLACE THE VALUES PREVIOUSLY PROVIDED: (B)(4) (L1). (B)(4) (L1-L22). NO OTHER CORRECTIONS OR ADDITIONAL INFORMATION HAVE BEEN INCORPORATED TO THE.CSV FILE PREVIOUSLY SUBMITTED THROUGH FOLLOW-UP REPORT 1020279-2025-01706.
REPORTING QUARTER: 3 (JUL 1 - SEP 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 REDAPT MONOLITHIC REVISION STEMS IN THAS. PRIMARY PROCEDURES A TOTAL OF EIGHTY-FIVE (85) HIPS UNDERWENT PRIMARY THA BETWEEN 4-AUG-2017 AND 4-JUN-2025, USING A REDAPT MONOLITHIC REVISION STEM. FROM THESE, ONE (1) HIP WAS LATER REVISED DUE TO INFECTION. REVISION PROCEDURES: A TOTAL OF FOUR HUNDRED AND THIRTY-SEVEN (437) HIPS UNDERWENT REVISION THA BETWEEN 3-FEB-2017 AND 25-JUN-2025, USING A REDAPT MONOLITHIC REVISION STEM. FROM THESE, TWENTY-TWO (22) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: EIGHT (8) HIPS DUE TO ASEPTIC LOOSENING OF THE STEM, SIX (6) HIPS DUE TO DISLOCATION/SUBLUXATION, THREE (3) HIPS DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, TWO (2) HIPS DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, TWO (2) HIPS DUE TO ASEPTIC LOOSENING OF THE SOCKET, TWO (2) HIPS DUE TO INFECTION, TWO (2) HIPS DUE TO LYSIS OF THE SOCKET, TWO (2) HIPS DUE TO PERIPROSTHETIC FRACTURE, ONE (1) HIP DUE TO INCORRECT SIZING OF THE SOCKET, ONE (1) HIP DUE TO LEG LENGTH DISCREPANCY, ONE (1) HIP DUE TO LYSIS OF THE STEM, ONE (1) HIP DUE TO MALALIGNMENT OF THE SOCKET, AND ONE (1) HIP DUE TO PAIN. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF 1 THA REVISION AND 22 THA RE-REVISIONS (23 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE NATIONAL JOINT REGISTRY (NJR). ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE REDAPT MONO SLEEVELESS STEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. A TOTAL OF 85 PRIMARY THA IMPLANTATIONS WITH THE REDAPT MONOLITHIC REVISION FEMORAL SYSTEM WERE PERFORMED IN THE UNITED KINGDOM BETWEEN 4-AUG-2017 AND 4-JUN-2025 WITH ONLY ONE REVISION REPORTED. THE ONE REVISION WAS AN ISOLATED HEAD AND/OR LINER EXCHANGE DUE TO INFECTION. THE MEAN KAPLAN-MEIER REVISION RATE FOR REDAPT MONO SLEEVELESS STEM IS IN LINE WITH THE CLASS AS DEMONSTRATED BY OVERLAPPING CONFIDENCE INTERVALS ACROSS 5 YEARS OF FOLLOW UP, WITH LARGE CONFIDENCE INTERVALS DUE TO THE LOW NUMBER OF RECORDED IMPLANTATIONS. A TOTAL OF 437 REVISION THA PROCEDURES WITH REDAPT MONO SLEEVELESS STEM WERE PERFORMED, WITH 22 REVISIONS REPORTED. THE CUMULATIVE RE-REVISION RATE OF REDAPT MONOLITHIC STEMS WAS SIGNIFICANTLY LOWER THAN THE CLASS DEVICE BETWEEN 1 TO 3 YEARS AND AT 7 YEARS WHEN CONSIDERING THE NON-OVERLAPPING CONFIDENCE INTERVALS. ON 5TH YEAR, THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE AMONG THESE RE-REVISION RATES. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.
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-2025-00284560-1-L1,5/10/2019,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 15 STANDARD OFFSET,71354464,17BTM0002A,71354464,,00885556580585,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of eighty-five (85) hips underwent primary THA between 4-Aug-2017 and 4-Jul-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) hip were later revised due to infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of eighty-five (85) hips underwent primary THA between 4-Aug-2017 and 4-Jul-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) hip were later revised due to infection. ;;Timeframe of Registry data: Implantations conducted between 4-Aug-2017 and 4-Jul-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighty-five (85) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 4-Aug-2017 and 4-Jul-2025. ;;The cumulative revision rates for the REDAPT Mono Sleeveless stem are in line with the class as demonstrated by overlapping confidence intervals across 5 years, with large confidence intervals due to the low number of recorded implantations (N=85). There was only one revision due to infection and it was an isolated head and/or liner exchange that did not involve the stem.;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 1.27% (0.18%¿8.65%) vs 0.92% (0.89%¿0.94%) of the class.;¿At 3rd postoperative year: 1.27% (0.18%¿8.65%) vs 1.63% (0.89%¿0.94%) of the class.;¿At 5th postoperative year: 1.27% (0.18%¿8.65%) vs 2.63% (2.26%¿2.34%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for Primary Procedure: Metastatic Cancer,62,Female,,1/25/2019,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L1,10/7/2017,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 300MM SLEEVELESS REVISION STEM SIZE 15 HIGH OFFSET,71354757,16dtm0019g,71354757,,00885556579763,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Peri-Prosthetic Fracture of the Stem.,82,Female,,8/9/2017,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L2,1/25/2019,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 21 STANDARD OFFSET,71354711,17BT,71354711,,00885556579350,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Loosening of the stem.,83,Male,77,9/13/2018,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L3,2/20/2019,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 19 STANDARD OFFSET,71354468,17etm0040e,71354468,,00885556580622,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Loosening of the stem.,55,Female,,2/6/2019,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L4,8/14/2020,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 19 STANDARD OFFSET,71354468,16GTM0034D,71354468,,00885556580622,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Infection.,53,Female,,5/24/2019,,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L5,1/27/2021,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 17 HIGH OFFSET,71354724,17ftm0042c,71354724,,00885556579466,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Peri-Prosthetic Fracture of the Stem.,67,Male,,12/30/2020,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L6,1/29/2021,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 14 STANDARD OFFSET,71354463,16HTM0005H,71354463,,00885556580578,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Dislocation/Subluxation.,81,Female,,1/15/2021,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L7,9/17/2021,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 18 STANDARD OFFSET,71354467,19CTM0014A,71354467,,00885556580615,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Loosening of the stem.,84,Female,,8/1/2020,9/17/2021,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L8,11/10/2021,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 18 HIGH OFFSET,71354485,16mtm0095e,71354485,,00885556580790,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Loosening of the stem.,80,Male,,10/5/2021,11/10/2021,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L9,2/11/2022,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 13 STANDARD OFFSET,71354702,17gtm0042b,71354702,,00885556579169,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Peri-Prosthetic Fracture of the Stem.,70,Male,,9/14/2021,2/11/2022,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L10,1/17/2023,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 17 HIGH OFFSET,71354724,17GTM0083E,71354724,,00885556579466,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Dislocation/SubluxationandInfection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Infection.,74,Male,,6/3/2021,1/17/2023,E1614;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L11,4/26/2023,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 14 STANDARD OFFSET,71354463,20etm0012n,71354463,,00885556580578,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Peri-Prosthetic Fracture Stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Peri-Prosthetic Fracture of the Stem.,87,Female,,4/5/2023,4/26/2023,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L12,1/8/2024,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 18 STANDARD OFFSET,71354707,16gtm0010k,71354707,,00885556579329,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Lysis Stem,Lysis Socket and Infection.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Loosening of the stem and Peri-Prosthetic Fracture of the Stem.,53,Female,,6/8/2021,1/8/2024,E1627;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L13,2/16/2024,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 300MM SLEEVELESS REVISION STEM SIZE 16 STANDARD OFFSET,71354741,17etm0132a,71354741,,00885556579619,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Loosening stem and Leg Length Discrepancy.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Peri-Prosthetic Fracture of the Stem.,65,Male,,2/23/2023,2/16/2024,E161201;E1634,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L14,4/23/2024,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 300MM SLEEVELESS REVISION STEM SIZE 13 HIGH OFFSET,71354755,17atm0080b,71354755,,00885556579749,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Dislocation/Subluxation.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Peri-Prosthetic Fracture of the Stem.,61,Male,,2/14/2023,4/23/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L15,4/25/2024,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 17 STANDARD OFFSET,71354706,19BTM0011D,71354706,,00885556579312,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Peri-Prosthetic Fracture of the Stem and Infection.,67,Female,,7/31/2020,4/25/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L16,7/10/2024,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 15 HIGH OFFSET,71354482,21ETM0003G,71354482,,00885556580769,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Periprosthetic Fracture.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Periprosthetic Fracture.,76,Male,,2/10/2024,7/10/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L17,8/19/2024,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 14 STANDARD OFFSET,71354463,18KTM0016C,71354463,,00885556580578,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Loosening socket and Malalignment Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Malalignment of the Socket, Leg Length Discrepancy and Periprosthetic Fracture.",72,Female,,5/29/2024,,E161201;E2308,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L18,8/30/2024,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 14 STANDARD OFFSET,71354463,17gtm0040f,71354463,,00885556580578,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Loosening stem and Periprosthetic Fracture.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Leg Length Discrepancy.,64,Male,,7/17/2024,8/30/2024,E161201;E2127,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L19,9/6/2024,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 21 STANDARD OFFSET,71354711,17gtm0063e,71354711,,00885556579350,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Peri-Prosthetic Fracture of the Stem.,79,Male,,12/14/2022,9/6/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L20,11/1/2024,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 300MM SLEEVELESS REVISION STEM SIZE 12 HIGH OFFSET,71354754,17atm0094b,71354754,,00885556579732,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Loosening stem.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Peri-Prosthetic Fracture of the Stem.,67,Male,102,6/6/2023,11/1/2024,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L21,2/26/2025,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 16 STANDARD OFFSET,71354705,19GTM0020C,71354705,,00885556579305,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Loosening stem, Unexplained Pain and Head/Socket Mismatch Socket.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for revision procedure:Other.,80,Male,104,10/12/2020,2/26/2025,E161201;E2330;E2401,F1905,A0102;A24;A2303,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00284571-1-L22,5/23/2025,10/14/2025,7/30/2025,REDAPT Sleeveless Monolithic Revision Stem,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 16 STANDARD OFFSET,71354465,19htm0013a,71354465,,00885556580592,K211176,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, one (1) patient was later re-revised due to: Loosening socket, Lysis Socket and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 3 (Jul 1 - Sep 30, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred and thirty-seven (437) hips underwent revision THA between 3-Feb-2017 and 25-Jun-2025, using a REDAPT Monolithic Revision Stem. From these, twenty-two (22) hips were later re-revised due to the following reasons: eight (8) hips due to aseptic loosening of the stem, six (6) hips due to dislocation/subluxation, three (3) hips due to periprosthetic fracture of the stem, two (2) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to aseptic loosening of the socket, two (2) hips due to infection, two (2) hips due to lysis of the socket, two (2) hips due to periprosthetic fracture, one (1) hip due to incorrect sizing of the socket, one (1) hip due to leg length discrepancy, one (1) hip due to lysis of the stem, one (1) hip due to malalignment of the socket, and one (1) hip due to pain. It should be noted that multiple reasons may be listed for one revision procedure.;;Timeframe of Registry data: Implantations conducted between 3-Feb-2017 and 25-Jun-2025 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Mono Sleeveless stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four hundred and thirty-seven (437) procedures with REDAPT Mono Sleeveless stem were performed in United Kingdom between 3-Feb-2017 and 25-Jun-2025. ;;The cumulative re-revision rate of REDAPT Monolithic stems was significantly lower than the class device between 1 to 3 years and at 7 years when considering the non-overlapping confidence intervals. On 5th year, re-revision rate was also lower than the class but with an overlapping confidence interval.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;¿At 1st postoperative year: 2.92% (1.67%¿5.09%) vs 5.53% (5.22%¿5.86%) of the class.;¿At 3rd postoperative year: 5.74% (3.7%¿8.86%) vs 9.65% (9.23%¿10.09%) of the class.;¿At 5th postoperative year: 7.29% (4.64%¿11.38%) vs 11.72% (11.25%¿12.21%) of the class.;¿At 7th postoperative year: 7.29% (4.64%¿11.38%) vs 13.41% (12.89%¿13.95%) of the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for revision procedure:Lysis of the Stem, Lysis of the Socket and Adverse Soft Tissue Reaction to Particulate Debris.",72,Female,96,5/3/2023,,E161201;E1627;E040203,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,1;
BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN UNITED KINGDOM FOLLOWING THE USE OF REDAPT MONOLITHIC REVISION STEMS IN THAS. PRIMARY PROCEDURES: A TOTAL OF EIGHTY-FIVE (85) HIPS UNDERWENT PRIMARY THA BETWEEN 4-AUG-2017 AND 4-JUN-2025, USING A REDAPT MONOLITHIC REVISION STEM. FROM THESE, ONE (1) HIP WAS LATER REVISED DUE TO INFECTION. REVISION PROCEDURES: A TOTAL OF FOUR HUNDRED AND THIRTY-SEVEN (437) HIPS UNDERWENT REVISION THA BETWEEN 3-FEB-2017 AND 25-JUN-2025, USING A REDAPT MONOLITHIC REVISION STEM. FROM THESE, TWENTY-TWO (22) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: EIGHT (8) HIPS DUE TO ASEPTIC LOOSENING OF THE STEM, SIX (6) HIPS DUE TO DISLOCATION/SUBLUXATION, THREE (3) HIPS DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, TWO (2) HIPS DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, TWO (2) HIPS DUE TO ASEPTIC LOOSENING OF THE SOCKET, TWO (2) HIPS DUE TO INFECTION, TWO (2) HIPS DUE TO LYSIS OF THE SOCKET, TWO (2) HIPS DUE TO PERIPROSTHETIC FRACTURE, ONE (1) HIP DUE TO INCORRECT SIZING OF THE SOCKET, ONE (1) HIP DUE TO LEG LENGTH DISCREPANCY, ONE (1) HIP DUE TO LYSIS OF THE STEM, ONE (1) HIP DUE TO MALALIGNMENT OF THE SOCKET, AND ONE (1) HIP DUE TO PAIN. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF 1 THA REVISION AND 22 THA RE-REVISIONS (23 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE NATIONAL JOINT REGISTRY (NJR).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2004184 | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU | MEH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Unknown | Hospitalization| R |