BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L

    MDR report key: 10850270 · Received November 17, 2020

    Report

    Report Number
    3005180920-2020-00808
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 17, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862472
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 OCTOBER 2020: LOT#: 171804: 64 ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2017. EXPIRATION DATE: 2022-06-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 60 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1202L TIBIAL TRAY FIXED CEMENTED SIZE 2 L (K090988) LOT.#: 171138. BATCH REVIEW PERFORMED ON 30 OCTOBER 2020. LOT #: 171138: 67 ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2017. EXPIRATION DATE: 2022-06-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 66 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, ONE YEAR AND 6 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO LOOSE IMPLANTS. THE CAUSE OF LOOSE IMPLANTS IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, INSERT, AND ADDED AN OFFSET CONNECTOR, AND 2 EXTENSION STEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315326 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0022L 171804 07630030862472

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention