BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT ACET. INSERT 10 DEGREE

    MDR report key: 645834 · Received November 10, 2005

    Report

    Report Number
    2249697-2005-00125
    Event Type
    Injury
    Date Received
    November 10, 2005
    Date of Event
    February 7, 2002
    Report Date
    October 14, 2005
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LWJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT TOTAL HIP REPLACEMENT ON JUNE 14, 1999. THE PT UNDERWENT REVISION SURGERY DUE TO POLYETHYLENE WEAR IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT ACET. INSERT 10 DEGREE IMPLANT LWJ STRYKER ORTHOPAEDICS MAHWAH NA 1MNHA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention