BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS HIP SYSTEM FEMORAL STEM FIBER METAL TAPER COLLARLESS

    MDR report key: 1061059 · Received June 13, 2008

    Report

    Report Number
    1822565-2008-00317
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: X-RAY REVEALS RADIO TRANSPARENCY TOWARDS DISTAL END OF THE STEM. SURGEON NOTES ARE NOT AVAILABLE TO ASSESS THE PROCEEDINGS OF THE SURGERY. TYPE OF RASP AND REAMER USED IS NOT KNOWN. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN EARLY 2008. POST-OP, THE DEVICE HAS SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL STEM FIBER METAL TAPER COLLARLESS HIP PROSTHESIS KWY ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR