BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION 02.07.0312SCF FIXED TIBIAL INSERT SC SIZE 3/12MM

    MDR report key: 16068470 · Received December 29, 2022

    Report

    Report Number
    3005180920-2022-00981
    Event Type
    Injury
    Date Received
    December 29, 2022
    Date of Event
    December 16, 2022
    Report Date
    December 29, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817175
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022: LOT 183190: 18 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2018. EXPIRATION DATE: 2023-07-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 9 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2824440 GMK-REVISION 02.07.0312SCF FIXED TIBIAL INSERT SC SIZE 3/12MM KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0312SCF 183190 07630030817175

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention