BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE CONSTRUCT SIGMA

    MDR report key: 22610987 · Received July 25, 2025

    Report

    Report Number
    1818910-2025-12941
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    April 23, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: OLSON NR, STRAIT AV, HO PH, FRICKA KB, HAMILTON WG, SERSHON RA. NEW AND IMPROVED? ANALYSIS OF GENERATIONAL IMPLANT-RELATED FAILURES AND ALL-CAUSE REVISION INDICATIONS FOR TOTAL KNEE ARTHROPLASTY OVER A 30-YEAR PERIOD. J ARTHROPLASTY. 2025 APR 23:S0883-5403(25)00383-3. DOI: 10.1016/J.ARTH.2025.04.046. EPUB AHEAD OF PRINT. PMID: 40280210. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY WAS TO DETERMINE IF MATERIAL AND TECHNICAL ADVANCEMENTS IN TKA DESIGN OVER THREE DECADES HAVE TRANSLATED TO IMPROVEMENTS IN IMPLANT-RELATED REVISIONS, SURVIVORSHIP, AND PATIENT-REPORTED OUTCOME MEASURES (PROMS) AT A HIGH-VOLUME INSTITUTION. BETWEEN FEBRUARY 1995 AND FEBRUARY 2024, A TOTAL OF 11,767 TKAS PERFORMED WERE INCLUDED IN THE STUDY, COMPRISED OF 7,002 (62.8% WOMEN; MEAN AGE OF 67.4 (21.3 TO 96.0) YEARS) PREVIOUS-GENERATION AND 4,765 (67.0% WOMEN; MEAN AGE OF 67.8 (30.0 TO 97.6) YEARS) CURRENT-GENERATION TKAS. THE EARLIER-GENERATION IMPLANTS INCLUDED SIGMA (DEPUY SYNTHES, WARSAW, INDIANA) USED IN 4,481PATIENTS, LEGION (SMITH & NEPHEW, MEMPHIS, TENNESSEE) IN 1,196 PATIENTS, AND NEXGEN (ZIMMER BIOMET, WARSAW, INDIANA) IN 1,325 PATIENTS. THE CURRENT TKA DESIGNS WERE ATTUNE (DEPUY SYNTHES, WARSAW, INDIANA) IN 1908 PATIENTS, JOURNEY II (SMITH & NEPHEW, MEMPHIS, TENNESSEE) IN 261 PATIENTS, AND PERSONA (ZIMMER BIOMET, WARSAW, INDIANA) IN 2,596 PATIENTS. THE STUDY POPULATION WAS FURTHER LIMITED TO CEMENTED TKAS TO DIRECTLY COMPARE DIFFERENT GENERATIONS, AS VERY FEW PRIOR-GENERATION CASES WERE PERFORMED WITH CEMENTLESS FIXATION. PATIENTS WHO RECEIVED PREVIOUS-GENERATION IMPLANTS HAD SIGNIFICANTLY LONGER MEAN FOLLOW-UP (MEAN 6.6, 0 TO 25.3 VERSUS 2.9, 0 TO 11.2 YEARS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES SIGMA AND ATTUNE. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: CEMENT (UNKNOWN MANUFACTURER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT SIGMA (QTY 71): - (N=2) ARTHROFIBROSIS/STIFFNESS TREATED WITH REVISIONS. - (N=8) INSTABILITY TREATED WITH REVISIONS. - (N=5) PERIPROSTHETIC FRACTURE TREATED WITH REVISIONS. - (N=1) HEMARTHROSIS TREATED WITH REVISIONS. - (N=46) INFECTION TREATED WITH REVISIONS. - (N=2) TRAUMATIC WOUND DEHISCENCE TREATED WITH REVISIONS. - (N=7) OTHER COMPLICATIONS TREATED WITH REVISIONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE TIBIAL INSERT SIGMA (QTY 16): - (N=16) POLY WEAR/OSTEOLYSIS TREATED WITH REVISIONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE TIBIAL TRAY SIGMA AND UNK KNEE FEMORAL SIGMA (QTY 37): - (N=37) ASEPTIC LOOSENING TREATED WITH REVISIONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT ATTUNE (QTY 40): - (N=2) ARTHROFIBROSIS/STIFFNESS TREATED WITH REVISIONS. - (N=1) INSTABILITY TREATED WITH REVISIONS. - (N=2) PERIPROSTHETIC FRACTURE TREATED WITH REVISIONS. - (N=4) EXTENSOR MECHANISM DISRUPTION TREATED WITH REVISIONS. - (N=19) INFECTION TREATED WITH REVISIONS. - (N=1) PAIN TREATED WITH REVISIONS. - (N=8) TRAUMATIC WOUND DEHISCENCE TREATED WITH REVISIONS. - (N=3) OTHER COMPLICATIONS TREATED WITH REVISIONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE KNEE TIBIAL TRAY AND UNK ATTUNE FEMORAL (QTY 7): - (N=1) COMPONENT BREAKAGE TREATED WITH REVISIONS. - (N=6) ASEPTIC LOOSENING TREATED WITH REVISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381952 UNKNOWN KNEE CONSTRUCT SIGMA KNEE FEMORAL IMPLANT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention