BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/12 MM L

    MDR report key: 19465818 · Received June 5, 2024

    Report

    Report Number
    3005180920-2024-00372
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    May 6, 2024
    Report Date
    June 5, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040707374
    PMA / PMN Number
    K181635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10-MAY-2024 LOT 2002122: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAY-2020. EXPIRATION DATE: 2025-05-04. 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

    AT ABOUT 2 YEARS AND 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE INSERT (12MM) WITH A THICKER ONE (14MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524044 GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/12 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2002122 07630040707374

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention