BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L

    MDR report key: 12874307 · Received November 25, 2021

    Report

    Report Number
    3005180920-2021-00910
    Event Type
    Injury
    Date Received
    November 25, 2021
    Date of Event
    October 26, 2021
    Report Date
    November 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825811
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04.11.2021; LOT 2011998: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2021. EXPIRATION DATE: 2025-12-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0311FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L (K140826) LOT 2012698: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2021. EXPIRATION DATE: 2026-02-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 18 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT SUCCESSFULLY. AFTER THE PRIMARY SURGERY, THE PATIENT HAS VASCULAR SURGERY ON THE IMPLANTED LEG AND BECAME VERY UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773694 GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0003L 2011998 07630030825811

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other