BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC # 4/14MM

    MDR report key: 7372841 · Received March 27, 2018

    Report

    Report Number
    3005180920-2018-00185
    Event Type
    Injury
    Date Received
    March 27, 2018
    Date of Event
    February 27, 2018
    Report Date
    March 27, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817878
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 MARCH 2018; LOT 151200: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 APRIL 2015. EXPIRATION DATE: 2020-03-31. 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. GMK-REVISION PATELLA RESURFACING # 2 REFERENCE 02.07.0034RP (K090988); LOT 154688: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 NOVEMBER 2015. EXPIRATION DATE: 2020-11-08. 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 DUE TO SIGNS OF INFECTION 2 YEARS AFTER PRIMARY. THE PATHOGEN IS NOT AVAILABLE. THE SURGEON REVISED THE PATELLA AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218168 GMK-REVISION FIXED TIBIAL INSERT SC # 4/14MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 151200 07630030817878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention