BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE

    MDR report key: 4914861 · Received July 13, 2015

    Report

    Report Number
    1822565-2015-01176
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Report Date
    June 12, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE FOUND. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNK. THIS DEVICE IS USED FOR TREATMENT. A PRODUCT HISTORY SEARCH REVEALED NO ADD'L COMPLAINTS AGAINST THE RELATED PART AND LOT COMBINATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ARTICULAR SURFACE WOULD NOT SEAT ON THE TIBIAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452931 NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE JWH ZIMMER, INC. 61827612

    Patients

    Seq Age Sex Outcome Treatment
    1