BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    MDR report key: 12187885 · Received July 19, 2021

    Report

    Report Number
    3005180920-2021-00614
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 19, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 JULY 2021. LOT 2010164: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2021. EXPIRATION DATE: 2026-01-13. 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

    2 DAYS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED THAT THE PATIENT WAS IN EXCESSIVE VALGUS. THE SURGEON REVISED THE FEMORAL COMPONENT, PATELLA, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087989 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0004R 2010164 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention