BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITANIUM REVISION ACETABULAR

    MDR report key: 1973849 · Received January 14, 2011

    Report

    Report Number
    2249697-2011-00048
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 20, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K010170
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "REVISED DUE TO ASCEPTIC LOOSENING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRITANIUM REVISION ACETABULAR IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA V20MDE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R