BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS PROLONG ARTICULAR SURFACE

    MDR report key: 3252164 · Received July 25, 2013

    Report

    Report Number
    1822565-2013-01155
    Event Type
    Injury
    Date Received
    July 25, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 25, 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

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, AND TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. THE WEAR INDICATED ON THE POST IS LIKELY TO OCCUR DUE TO INTERNAL TIBIAL ROTATION COUPLED WITH DEEP FLEXION. THE PT'S HIGH ACTIVITY LEVEL MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE FAILURE OF THE DEVICE; HOWEVER, THE NATURE OF THIS ACTIVITY IS UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL CODES: THE DHR HAS BEEN REVIEWED AND THE LOT IN QUESTION WAS PRODUCED, INSPECTED AND PACKAGED WITHIN ESTABLISHED AND VALIDATED PROCESS PARAMETERS. THE DEVICE WAS RECEIVED AND EVALUATED TO FIND THAT THE POST HAD FRACTURED. SIGNIFICANT WEAR WAS NOTED ON THE MEDIAL POSTERIOR CORNER OF THE TIBIAL POST. ADDITIONALLY, MINIMAL CONDYLAR AND BACKSIDE WEAR WERE PRESENT. SHOULD ADDITIONAL 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 THE POST ON THE ARTICULAR SURFACE BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348303 NEXGEN LPS PROLONG ARTICULAR SURFACE JWH ZIMMER, INC. 60836906

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention