BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS FEMORAL COMPONENT

    MDR report key: 1934493 · Received November 23, 2010

    Report

    Report Number
    1822565-2010-01197
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS UNKNOWN WHETHER A REVISION SURGERY WAS PERFORMED OR NOT. THERE ARE NO RETURNED PRODUCTS OR X-RAYS AVAILABLE. WITHOUT FURTHER INFORMATION ON THE SURGERY AND/OR RETURN OF PRODUCT, A PROBABLY CAUSE FOR ALLEGED DEFICIENCY CANNOT BE DETERMINED. 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 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 PROSTHESIS FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 60138972

    Patients

    Seq Age Sex Outcome Treatment
    1