BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FIXED PS LINER SIZE 4, 10 MM

    MDR report key: 4346580 · Received December 9, 2014

    Report

    Report Number
    3005180920-2014-00175
    Event Type
    Injury
    Date Received
    December 9, 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 4, 10 MM: CODE 02.07.0410 PSF/LOT 133289 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    IMP REFERENCE - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792574 GMK FIXED PS LINER SIZE 4, 10 MM FIXED PE POSTERO STABILIZED LINER JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1