BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN GSF LPS-FLEX FEMORAL COMPONENT

    MDR report key: 3124320 · Received May 14, 2013

    Report

    Report Number
    1822565-2013-00787
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    January 19, 2011
    Report Date
    April 15, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A DOCUMENT FROM (B)(6) HOSPITAL INDICATES THE REVISION WAS SCHEDULED DUE TO COBALT ALLERGY. NO TEST REPORTS OR SURGICAL REPORTS WERE PROVIDED. ZIMMER MAKES INFORMATION AVAILABLE IN THE PUBLIC DOMAIN RELATED TO THE COMPOSITION OF ZIMMER METAL IMPLANTS. EVALUATION: 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 IS REPORTED THAT THE PATIENT WAS REVISED DUE TO COBALT ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213157 NEXGEN GSF LPS-FLEX FEMORAL COMPONENT JWH ZIMMER, INC. 61428442

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention