BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 3529580 · Received December 17, 2013

    Report

    Report Number
    3007963827-2013-00045
    Event Type
    Injury
    Date Received
    December 17, 2013
    Date of Event
    January 25, 2013
    Report Date
    November 19, 2013
    Manufacturer
    ZIMMER ORTHOPEDIC MFG LTD
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNK. 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINE WITH THE INFO PROVIDED. EVAL CODES: 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REPONED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659153 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER ORTHOPEDIC MFG LTD 61504482

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention