BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10

    MDR report key: 15931589 · Received December 7, 2022

    Report

    Report Number
    3005180920-2022-00922
    Event Type
    Injury
    Date Received
    December 7, 2022
    Date of Event
    November 17, 2022
    Report Date
    December 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826542
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 NOVEMBER 2022: LOT 2002792: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2020. EXPIRATION DATE: 2025-APR-02. 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 PATELLA PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE INSERT (FROM 10 TO 12). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471251 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0410FR 2002792 07630030826542

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention