BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER ZIRCONIA FEMORAL HEAD

    MDR report key: 1478090 · Received September 18, 2009

    Report

    Report Number
    1822565-2009-00999
    Event Type
    Injury
    Date Received
    September 18, 2009
    Date of Event
    August 20, 2009
    Report Date
    August 21, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    Z-0239/0240-02
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PREVIOUSLY ADDRESSED SUPPLIER ISSUE. THE DEVICE WAS IN VIVO FOR APPROX 10 YEARS. NO PRODUCT WAS RETURNED FOR EVAL. THE RECEIVED X-RAY IMAGES WERE REVIEWED AND IT WAS OBSERVED THAT THE FEMORAL HEAD OF THE LEFT TOTAL HIP WAS FRACTURED. EVAL: THE ZIRCONIA FEMORAL HEAD ITEM # LOT#: 62204500 IS WITHIN THE SCOPE OF RECALL Z-0239/0240-02 DUE TO THE FRACTURING OF THE FEMORAL HEAD. THE RECALL IS COMPLETE AND NO FURTHER MANUFACTURE OR MARKETING OF THE ZIRCONIA FEMORAL HEAD OF THE 9030 FAMILY OCCURS. THE DEVICE WAS IMPLANTED BEFORE THE RECALL TOOK EFFECT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 1999, AND REVISED IN 2009, DUE TO THE FEMORAL HEAD BREAKING TWO DAYS PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER ZIRCONIA FEMORAL HEAD HIP PROSTHESIS KWY ZIMMER, INC. NA 62204500

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R