BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION TIBIAL TRAY CEMENTED SIZE 2

    MDR report key: 10023934 · Received May 5, 2020

    Report

    Report Number
    3005180920-2020-00276
    Event Type
    Injury
    Date Received
    May 5, 2020
    Date of Event
    March 19, 2020
    Report Date
    May 5, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 21 APRIL 2020: LOT 186206: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2018. EXPIRATION DATE: 2023-11-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: GMK-REVISION 02.07.0212SCF FIXED TIBIAL INSERT SC SIZE 2/12MM (K103170) BATCH REVIEW: PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 21 APRIL 2020: LOT 185104: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-SEP-2018. EXPIRATION DATE: 2023-08-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: EARLY INFECTION IN TKA, FEW WEEKS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TKA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1,5 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION, STRAPHLOCCOCUS EPIDERMIS AT THE TIBIAL PART. THE PATIENT HAD DAMAGED LIGAMENTS AND FOR THIS REVISION IMPLANTS WERE USED DURING THE PRIMARY SURGERY. THE SURGEON REVISED ALL TIBIAL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487057 GMK-REVISION TIBIAL TRAY CEMENTED SIZE 2 KNEE TIBIAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.1202R 186206 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention