BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA V40-FEMORAL HEAD 32MM, +4MM NK

    MDR report key: 2120341 · Received June 2, 2011

    Report

    Report Number
    9616680-2011-00368
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K023901
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "CERAMIC HEAD FRAGMENTED INTO MULTIPLE PIECES AND DESTROYED THE TRUNNION OF THE FEMORAL STEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA V40-FEMORAL HEAD 32MM, +4MM NK IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 22582901

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention