BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE

    MDR report key: 3002333 · Received March 7, 2013

    Report

    Report Number
    2648920-2013-00067
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 9, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPORTED TO HAVE BEEN SCRAPPED AND NO PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE DEVICE IS UNK. IF THE FIRST INSERTION ATTEMPT CAUSED DOVETAIL DAMAGE, AS MAY HAPPEN IF THE DEVICE WAS NOT INSERTED PROPERLY, THIS DAMAGE MAY CAUSE SUCCESSIVE ATTEMPTS TO BE UNSUCCESSFUL AS WELL. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL CODES: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARTICULAR SURFACE WOULD NOT LOCK INTO THE BASEPLATE AFTER SEVERAL ATTEMPTS. A NEW IMPLANT WAS OPENED TO COMPLETE THE PROCEDURE, WHICH LOCKED IN WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97576 NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE JWH ZIMMER 62208812

    Patients

    Seq Age Sex Outcome Treatment
    1