BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL STEM FIBER METAL TAPER COLLARLESS NECK TAPER

    MDR report key: 1060440 · Received June 13, 2008

    Report

    Report Number
    1822565-2008-00320
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 19, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE REC'D, 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 2007. THE DEVICE WAS REVISED IN 2008, DUE TO THE SHAFT FRACTURING AT THE LESSER TROCHANTER AND MEDIAL SHAFT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R