BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 24558207 · Received March 10, 2026

    Report

    Report Number
    3005180920-2026-00111
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 10, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816727
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 FEBRUARY 2026. LOT 181095: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAR-2018. EXPIRATION DATE: 27-MAR-2023. 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. ROOT CAUSE:THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE WAS A SUSPECTED LOOSE IMPLANT. DURING THE REVISION SURGERY, PERFORMED ABOUT 7 YEARS AND 2 MONTHS AFTER THE PRIAMRY SURGERY, IT WAS DISCOVERED THAT THE PATIENT HAD SUSTAINED AN MCL INJURY THAT WAS CAUSING THE INSTABILITY. THERE WAS NO FALL OR TRAUMA GIVEN FOR THE MCL INJURY. THE SURGEON DID NOT ADDRESS THE MCL BUT UPSIZED THE POLY (FROM 14MM TO 20MM) TO ADDRESS THE INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621502 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL INSERT STD FIX S.2 / 14 MM JWH MEDACTA INTERNATIONAL SA 02.07.0214SF 181095 07630030816727

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention