BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FIXED PS LINER SIZE 3 / 12MM

    MDR report key: 3870179 · Received May 23, 2014

    Report

    Report Number
    3005180920-2014-00059
    Event Type
    Injury
    Date Received
    May 23, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY FIXED PE POSTERO STABILIZED TIBIAL INSERT SIZE 3, 12MM: CODE 02.07.0312PSF / LOT 121128 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. (B)(4) ITEMS BELONG TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. FROM THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE PROBLEM IS DEVICE RELATED, BUT IT IS LIKELY ASSOCIATED TO AN ISSUE OCCURRED DURING THE PRIMARY SURGERY - BREAKAGE OF THE PS SCREW - AND NOT DETECTED BY THE SURGEON.

    Description of Event or Problem · 1

    REFERENCE IMPORTER # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308880 GMK FIXED PS LINER SIZE 3 / 12MM FIXED PE POSTERO STAB TIBIAL INSERT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1