BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FIXED PS LINER SIZE 2 - 2- MM

    MDR report key: 3322029 · Received August 23, 2013

    Report

    Report Number
    3005180920-2013-00098
    Event Type
    Injury
    Date Received
    August 23, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: (B)(4) PRIMARY FIXED PS TIBIAL INSERT SIZE 2 THICKNESS 20: CODE (B)(4)/ LOT 092118 (30 ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. FOUR ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE REVISION IS DEVICE RELATED. (B)(4) PRIMARY FIXED PS TIBIAL INSERT SIZE 2 THICKNESS 20: CODE (B)(4)/ LOT 114223 (29 ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE BREAKAGE OF ITS SCREW DURING THE REVISION SURGERY IS HIGHLY LIKELY DUE TO SOMETHING WRONG OCCURRED DURING ITS TIGHTENING AND NOT DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMP # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411537 GMK FIXED PS LINER SIZE 2 - 2- MM KNEE POSTERO STABILIZED UHMWPE LINER LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1