BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 18612807 · Received January 31, 2024

    Report

    Report Number
    3005180920-2024-00008
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    January 8, 2024
    Report Date
    January 31, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    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 9 JANUARY 2024 LOT 174578: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2017. EXPIRATION DATE: 2022-OCT-09. 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. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 9 JANUARY 2024: GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L (K121416) LOT 172732: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2017. EXPIRATION DATE: 2022-OCT-02. 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. GMK-SPHERE 02.12.0412FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L (K121416) LOT 173773: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2017. EXPIRATION DATE: 2022-SEP-04. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY AND PAIN DUE TO TIBIAL SUBSIDENCE AND THE CAUSE IS UNKNOWN. ABOUT 5 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS WITH HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074546 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 174578 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention