BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 5538895 · Received March 31, 2016

    Report

    Report Number
    2648920-2016-00096
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    February 20, 2016
    Report Date
    January 6, 2017
    Manufacturer
    ZIMMER, TURPEAUX INDUSTRIAL PARK
    Product Code
    JDI
    PMA / PMN Number
    PREFER H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES IN DEVICE AVAILABLE FOR EVALUATION?, DATE RECEIVED BY MFR?, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, DEVICE EVALUATED BY MFR?. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICES USED: THE FOLLOWING DEVICES WERE MANUFACTURED BY ZIMMER INC. - (B)(4): CATALOG #65766201300, VERSYS POROUS TAPER STEM, LOT #60831468. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. UPDATE TO INCLUDE: PART: (B)(4), LOT 60779865 (K840643) PART: (B)(4), LOT 60831468 (EXEMPT)

    Additional Manufacturer Narrative · 1

    THE VERSYS FEMORAL HEAD WAS RETURNED FOR REVIEW. BLACK DEBRIS WAS NOTED ON THE HEAD TAPER. THE DIMENSIONS WERE FOUND CONFORMING TO PRINT SPECIFICATIONS WHERE MEASURED. THE DEBRIS WAS SEMI-QUANTITATIVELY ANALYZED UNDER SEM USING EDS. IT WAS DETERMINED THAT THE DEBRIS REVEALS FOREIGN ELEMENTS OF CARBON, OXYGEN, TITANIUM, AND CALCIUM. THE VERSYS FEMORAL STEM WAS NOT RETURNED FOR REVIEW AND REMAINS IMPLANTED. PRE-REVISION X-RAYS AND MRI WERE RETURNED. REVIEW OF THE DEVICE HISTORY RECORD REPORT SHOW NO DEVIATIONS OR ANOMALIES WERE NOTED IN THE MANUFACTURING PROCESS FOR THIS LOT. THE REPORTED DEVICES ARE USED FOR TREATMENT. REVIEW OF THE COMPLAINT HISTORY FOR THE FEMORAL STEM IN THIS COMPLAINT REVEALED ONE ADDITIONAL COMPLAINT OF THE SAME PART AND LOT COMBINATION WHICH DEALT WITH IN-VIVO CORROSION. NO FURTHER COMPLAINTS WERE FOUND INVOLVING THE FEMORAL HEAD PART AND LOT COMBINATION REPORTED. IT WAS CONFIRMED THAT THE DEVICE WAS USED IN AN APPROVED AND COMPATIBLE COMBINATION. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. EDS RESULTS SUGGEST THAT WEAR BUILDUP BETWEEN THE FEMORAL NECK AND HEAD. IT IS NOT KNOWN IF THIS BUILDUP IS DUE TO TAPER CORROSION, MICROMOTION, OR A COMBINATION OF THE TWO. THEREFORE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT'S HIP ARTHROPLASTY WAS REVISED DUE TO PAIN AND LOOSENING. BLACK MATTER WAS FOUND IN THE TAPER OF THE FEMORAL HEAD DURING REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192901 VERSYS FEMORAL HEAD JDI JDI ZIMMER, TURPEAUX INDUSTRIAL PARK 60779865

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention