BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA CERAMIC FEMORAL HEAD

    MDR report key: 3893802 · Received June 12, 2014

    Report

    Report Number
    1822565-2014-00743
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER X-RAYS NOR OPERATIVE NOTES HAVE BEEN REC'D. IT IS UNKNOWN IF ANY UNREPORTED TRAUMATIC EVENT LED TO THE IMPLANT FRACTURE. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. WITH THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE STATED. 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 REC'D, 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 A FRACTURED FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348659 ALUMINA CERAMIC FEMORAL HEAD LZO ZIMMER, INC. 60160217

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention