BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/10MM

    MDR report key: 7685640 · Received July 13, 2018

    Report

    Report Number
    3005180920-2018-00502
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 13, 2018
    Report Date
    July 13, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817076
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JULY 2018; LOT 121804: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 SEPTEMBER 2012. EXPIRATION DATE: 2017-08-31; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 2 YEARS AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR A INFECTION. LINER SWAP ONLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529211 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/10MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 121804 07630030817076

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention