BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE

    MDR report key: 3434352 · Received October 24, 2013

    Report

    Report Number
    1822565-2013-01545
    Event Type
    Injury
    Date Received
    October 24, 2013
    Date of Event
    September 3, 2013
    Report Date
    September 26, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SURGICAL NOTES WERE PROVIDED FOR REVIEW. THE PRIMARY OPERATIVE NOTES STATE THAT WITH TRIAL COMPONENTS, EXCELLENT MOBILITY AND TRACKING WAS ACHIEVED. THE REVISION NOTES CONFIRMED THAT THE POST HAD FRACTURED REVISION NOTES CONFIRMED THAT THE POST HAD FRACTURED AND WAS FOUND WITHIN THE INTER-CONDYLAR NOTCH. THE FRACTURED PIECE AND THE REMAINING ARTICULAR SURFACE WERE EXCHANGED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. REVIEW OF COMPLAINT HISTORY FOUND NO OTHER REPORTS OF THIS NATURE. 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 SPECS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO MILD SWELLING, CLICKING OR POPPING, AND MILD HYPER EXTENSION. THE ARTICULAR SURFACE POST WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546204 NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE JWH ZIMMER, INC. 60637917

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention