BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP FEMORAL STEM

    MDR report key: 2172648 · Received July 20, 2011

    Report

    Report Number
    1822565-2011-01667
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE STEM AND HEAD WERE RETURNED FOR REVIEW. THERE IS NO NOTABLE DAMAGE TO THE DEVICES. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; THEREFORE THE FIT, ORIENTATION, AND CEMENT MANTLE CONDITION COULD NOT BE ANALYZED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNK. ADHERENCE TO REHAB PROTOCOL IS UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. THE MFG RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE DEVICES WERE MFG, INSPECTED, AND PACKAGED TO SPEC. 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 DISLOCATION. ADDITIONALLY STEM WAS FOUND TO BE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP FEMORAL STEM JDI ZIMMER 61238523

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention CATALOG #00781805300, LOT# 61522120| VERSYS HIP ENDO FEMORAL HEAD