BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK

    MDR report key: 1620563 · Received February 5, 2010

    Report

    Report Number
    9616680-2009-00668
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    July 14, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK, STRYKER ORTHOPAEDICS
    Product Code
    LZO
    PMA / PMN Number
    K023901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORP CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO THE (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (REVISION SURGERY REQUIRED AND PRODUCT CODE JDI).

    Description of Event or Problem · 1

    REVISION SURGERY REQUIRED. IT WAS REPORTED, "ATV ROLLOVER - FOR 2 1/2 WEEKS PT WALKED ON IT. THE CERAMIC HEAD FRAGMENT IN 30 PIECES. CERAMIC LINER MARKED BY METAL TRUNNION. REPLACED WITH 625-0T-32F (B) (4), (B) (4) & (B) (4). NECK/TRUNNION WERE DAMAGED & MARKED FROM RUBBING CUP INSERTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK IMPLANT LZO STRYKER ORTHOPAEDICS CORK, STRYKER ORTHOPAEDICS NA 11417601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention