BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 23153129 · Received September 26, 2025

    Report

    Report Number
    3005180920-2025-00893
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    June 11, 2022
    Report Date
    September 26, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2025. 02.07.0683R REVISION TIBIAL TRAY SIZE 3 RIGHT - FINISHING (K123721) LOT 186398: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2018 EXPIRATION DATE: 2023-OCT-18. 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. ADDITIONAL DEVICE INVOLVED IN THE EVENT: 02.07.2402R FEMUR REVISION PS CEMENTED S.2R (K102437) LOT 148060: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-DEC-2014 EXPIRATION DATE: 2019-OCT-31. 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

    IN 2014 PATIENT UNDERWENT PRIMARY TKA, DETAILS UNKNOWN. IN 2019 PATIENT UNDERWENT REVISION SURGERY AND GMK-REVISION DEVICES WERE IMPLANTED. IN (B)(6) 2022 ALL GMK-REVISION IMPLANTS WERE REVISED DUE TO MOBILIZATION; IT IS UNKNOWN WHICH IMPLANT WAS MOBILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311335 GMK REVISION TOTAL KNEE SYSTEM REVISION FIXED TIBIAL TRAY CEMENTED RIGHT, SIZE 3 JWH MEDACTA INTERNATIONAL SA 02.07.0683R 186398

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention