BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM 0MM V40 ALUMINA HEAD

    MDR report key: 1071398 · Received July 3, 2008

    Report

    Report Number
    9616680-2008-00181
    Event Type
    Injury
    Date Received
    July 3, 2008
    Date of Event
    May 18, 2008
    Report Date
    June 18, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K003413
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PT EXPERIENCED A SQUEAKING SOUND WHILE BENDING OVER. IN ADDITION, THE PT COULD FLEX HIS GLUTEUS MAXIMUS AND PRODUCE A CLUNKING SOUND AS WELL AS IMPINGEMENT REVEALED ON FLUORO. PT WAS REVISED TO A 40MM "G" X3 POLYETHYLENE LINER AND A V40 LFIT 40MM +4 HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 36MM 0MM V40 ALUMINA HEAD IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 7477301

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention