BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 12216403 · Received July 23, 2021

    Report

    Report Number
    3005180920-2021-00624
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    July 6, 2021
    Report Date
    July 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 JULY 2021: LOT 2002929: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2020. EXPIRATION DATE: 2025-06-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE SURGEON DID TOO MUCH VARUS CUT DURING THE PRIMARY SURGERY, SO HE PUT BONE WEDGES UNDER THE FINAL IMPLANT (USING PATIENT BONE AUTO GRAFT). REVISION SURGERY 8 MONTHS AFTER PRIMARY DUE TO BONE WEDGES THAT FAILED. TIBIAL COMPONENTS WERE REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116263 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1203L 2002929 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention