BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

    MDR report key: 19858758 · Received July 30, 2024

    Report

    Report Number
    3005180920-2024-00573
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 30, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    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 16 JULY 2024. LOT 1900358: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2019. EXPIRATION DATE: 2024-04-21. 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 HAD KNEE INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT ABOUT 4 YEARS AND 6 MONTHS POST PRIMARY THE SURGEON REVISED THE LINER (WITH A THICKER ONE) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244999 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1900358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention