BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 23153127 · Received September 26, 2025

    Report

    Report Number
    3005180920-2025-00894
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    November 1, 2023
    Report Date
    September 26, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03-SEP-2025. 02.07.1204L TIBIAL TRAY FIX CEMENTED S.4L LOT. 167418 (K090988) LOT 167418: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2017. EXPIRATION DATE: 2022-FEB-07. 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. 02.12.0004L GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4L (K121416) LOT 183471: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 2023-JUL-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY KNEE ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 5 YEARS FROM PRIMARY THE PATIENT UNDERWENT REVISION DUE TO MOBILIZATION. IT IN NOT KNOW WHICH DEVICE MOBILIZED. ALL DEVICES WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311333 GMK PRIMARY TOTAL KNEE SYSTEM FIXED TIBIAL TRAY CEMENTED LEFT, SIZE 4 JWH MEDACTA INTERNATIONAL SA 02.07.0683R02.07.1204L 167418

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention