BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L

    MDR report key: 18334828 · Received December 15, 2023

    Report

    Report Number
    3005180920-2023-01011
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 15, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819841
    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 13 DECEMBER 2023 LOT 103277: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2010. EXPIRATION DATE: 2015-09-30; 2 ITEMS REWORKED AND RELEASED ON 15-SEP-2016. EXPIRATION DATE: 2021-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 13 DECEMBER 2023: GMK-SPHERE 02.12.0110FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/10 MM L (K121416) LOT 187201: 30 ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2019. EXPIRATION DATE: 2024-01-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO TIBIAL TRAY FIXED CEMENTED SIZE 1 SUBSIDENCE AND KNEE INSTABILITY, AT ABOUT 2 YEARS 10 MONTHS AFTER THE PRIMARY. ALL COMPONENTS SUCCESSFULLY REVISED WITH COMPETITOR'S SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267458 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 103277 07630030819841

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention