BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 16644025 · Received March 30, 2023

    Report

    Report Number
    3005180920-2023-00175
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    February 27, 2023
    Report Date
    March 30, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023 LOT 2116013: 121 ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2022. EXPIRATION DATE: 2027-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 112 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL TRAY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS TO GMK-REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241374 GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1205R 2116013 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention