BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 10 MM

    MDR report key: 9961451 · Received April 15, 2020

    Report

    Report Number
    3005180920-2020-00239
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    March 16, 2020
    Report Date
    April 15, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817038
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 27 MARCH 2020: LOT 121962: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 SEP 2012. EXPIRATION DATE: 2017-07-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN 7 YEARS AND 4 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE MEDACTA TIBIAL INSERT U.C. FIX S.3 / 10 MM WITH A MEDACTA INSERT U.C. 10MM S3 AND RESURFACED THE PATELLA BONE. THE PATELLA WAS NOT RESURFACED DURING THE FIRST PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426939 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 10 MM TIBIAL INSERT UC FIXED JWH MEDACTA INTERNATIONAL SA 02.07.0310FUC 121962 07630030817038

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention