BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMORAL COMPONENT CEMENTED STD SIZE 3 / RIGHT

    MDR report key: 20180518 · Received September 10, 2024

    Report

    Report Number
    3005180920-2024-00715
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820205
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 AUGUST 2024. LOT 103700: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN -2011. EXPIRATION DATE: 2015-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT REVISED: BATCH REVIEW PERFORMED ON 20 AUGUST 2024 ON GMK-PRIMARY 02.07.0310FUC TIBIAL INSERT U.C. FIX S.3 / 10 MM (K090988) LOT. 104100 LOT 104100: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB -2011. EXPIRATION DATE: 2015-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE 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 HAD INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 13 YEARS AND 4 MONTHS POST PRIMARY THE SURGEON REVISED THE FEMUR AND POLY TO REVISION COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223535 GMK-PRIMARY FEMORAL COMPONENT CEMENTED STD SIZE 3 / RIGHT KNEE CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 103700 07630030820205

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention