BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 12 MM

    MDR report key: 14072306 · Received April 11, 2022

    Report

    Report Number
    3005180920-2022-00258
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    March 17, 2022
    Report Date
    April 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818349
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 APRIL 2022: LOT 133271: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JULY-2013. EXPIRATION DATE: 2018-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2018.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AFTER INJURING THEIR MCL AND THE CAUSE IS UNKNOWN. AT 5 YEARS AND 6 MONTHS AFTER PRIMARY THE SURGEON REPAIRED THE MCL AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED INSERT: 02.07.0514FUC INSERT U.C. 14MM S5 1904306.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822232 GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 12 MM KNEE TIBIAL INSERT PE JWH MEDACTA INTERNATIONAL SA 02.07.0512SF 133271 07630030818349

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention