BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL FEMORAL STEM

    MDR report key: 2994477 · Received March 5, 2013

    Report

    Report Number
    1822565-2013-00433
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    June 23, 2009
    Report Date
    February 5, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE WAS NOT RETURNED FOR REVIEW, THEREFORE ITS EXACT CONDITION IS UNK. PRIMARY OPERATIVE NOTES WERE PROVIDED WHICH NOTE THAT THE PT'S PREOPERATIVE DIAGNOSIS WAS AVASCULAR NECROSIS OF THE RIGHT HIP AFTER RADIATION FOR LYMPHOMA. A SIZE 12 TRABECULAR METAL FEMORAL COMPONENT WAS IMPLANTED AND NOTED TO HAVE OBTAINED EXCELLENT STABILITY. REVISION OPERATIVE NOTES STATE THAT THE FEMORAL COMPONENT WAS EVALUATED AND NOTED TO BE GROSSLY LOOSE. A PEDESTAL WAS ALSO NOTED IN THE DISTAL FEMUR. IN GENERAL, PT 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. CAUSE CANNOT BE DEFINITIVELY 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 EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL 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 THE FEMORAL STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93499 TRABECULAR METAL FEMORAL STEM LPH ZIMMER, INC. 60475365

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention