BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VERSYS FULLCOAT STEMS

    MDR report key: 1869493 · Received October 5, 2010

    Report

    Report Number
    1822565-2010-00838
    Event Type
    Injury
    Date Received
    October 5, 2010
    Report Date
    September 1, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: ITEM AND LOT NUMBERS OF THE STEMS HAVE NOT BEEN PROVIDED. ALSO, NO PHOTO OF THE CORRODED PRODUCT HAS BEEN PROVIDED FOR REVIEW. CORROSION AT THE JUNCTION OF MODULAR FEMORAL HEAD AND THE FEMORAL STEM HAS BEEN REPORTED IN THE LITERATURE AND RETRIEVAL STUDIES. ONE OR A COMBINATION OF THE FOLLOWING FACTORS MAY CONTRIBUTE TO THE FAILURE: MICROMOTION BETWEEN THE FEMORAL HEAD AND THE STEM CAN CAUSE FRETTING CORROSION; UNAPPROVED COUPLING (E.G. SST/COCR) MAY INCREASE THE CHANCE OF CORROSION; HEAVY PTS OR PT ACTIVITY MAY INCREASE THE STRESS AT THE HEAD-STEM JUNCTION CAUSING CORROSION. THIS IS NOT AN EXHAUSTIVE LIST. HOWEVER, NO DEFINITIVE CAUSE ANALYSIS CAN BE PERFORMED WITH CERTAINTY FOR THIS PARTICULAR ISSUE BASED ON THE INFO PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE AS THE PRODUCT AND 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 RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT CORROSION AROUND THE TAPERS OF VERSYS FULLCOAT STEMS IS OBSERVED DURING POY LINER/HEAD EXCHANGES - UNK NUMBER OF REVISIONS FOR UNK REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN VERSYS FULLCOAT STEMS HIP PROSTHESIS KWB ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention