BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE

    MDR report key: 3111184 · Received May 8, 2013

    Report

    Report Number
    1822565-2013-00755
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FROM 3500A. EVALUATION SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. ONE UN-DATED X-RAY OF ANTERIOR VIEW DOES NOT REVEAL ANYTHING SIGNIFICANT. SURGICAL REPORTS WERE NOT PROVIDED. THE INFORMATION PROVIDED INDICATES THAT THE REPORTED FAILURE MAY HAVE BEEN DUE TO THE FALL. 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELL, AND THE POST OF THE ARTICULAR SURFACE FRACTURED. THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202226 NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE JWH ZIMMER, INC. 61165761

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention