BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2871515 · Received December 6, 2012

    Report

    Report Number
    1822565-2012-02505
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO DEVICES, PHOTOS, SURGICAL NOTES OR X-RAYS WERE RECEIVED. ZIMMER MAKES INFO AVAILABLE IN THE PUBLIC DOMAIN RELATED TO THE COMPOSITION OF ZIMMER METAL IMPLANTS. THE AVAILABLE INFO DOES NOT INDICATE A PRODUCT FAILURE. THE COMPLAINT MAY BE REVISED UPON RETURN OF OPERATIVE REPORTS, X-RAYS AND/OR PRODUCT OR FURTHER INFO. EVAL: 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 PAIN. IT IS ALSO REPORTED THAT THE PT REPORTED THAT SHE WAS ALLERGIC TO NICKEL AFTER TOTAL KNEE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT MBH ZIMMER, INC. 60735938

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention