BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20426111 · Received October 11, 2024

    Report

    Report Number
    3005180920-2024-00807
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    September 12, 2024
    Report Date
    October 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825835
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19-SEP-2024. LOT 1910650: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2020. EXPIRATION DATE: 2025-03-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 4 YEARS AFTER REVISION TKA, THE PATIENT COMPLAINS OF KNEE PAIN AND A NEW REVISION IS UNDERTAKEN. NO FURTHER INFORMATION IS AVAILABLE. THE QUALITY OF THE IMAGES SUPPLIED IS SUCH THAT NO COMMENT CAN BE MADE FROM THEM. THE REPORT DOES NOT MENTION ANY PROBLEM WITH THE IMPLANTS, AND IN FACT IT SAYS EXPLICITLY THAT NO INFECTION AND NO LOOSENING WERE DETECTED. OTHER DEVICES INVOLVED: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L (K121416) LOT 2112453: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2021. EXPIRATION DATE: 2026-10-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3I4 L (K121416) LOT 2112049: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2021. EXPIRATION DATE: 2026-11-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT UNDERGONE PRIMARY SURGERY ON THE (B)(6) 2020 AND GMK-SPHERE COMPONENTS, WITHOUT PATELLA RESURFACING, HAVE BEEN IMPLANTED. ON THE (B)(6) 2022, THE PATIENT HAS BEEN REVISED BECAUSE OF ANTERIOR KNEE PAIN AND LOOSENING OF THE TIBIAL TRAY. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL TRAY AND INSERT AND IMPLANTED A RESURFACING PATELLA SIZE 1. PRESENTLY, ON THE (B)(6) 2024, THE PATIENT HAS BEEN REVISED DUE TO PAIN. NO LOOSENING AND INFECTION DETECTED. THE SURGEON REMOVED FEMORAL AND TIBIAL COMPONENTS AND INSERT AND IMPLANTED GMK-REVISION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344813 GMK SPHERE TOTAL KNEE SYSTEM KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0004L 1910650 07630030825835

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention