BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT SER. II INSERT-10 DEG.

    MDR report key: 2924552 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00110
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K943054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF ACETABULAR LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30666 OMNIFIT SER. II INSERT-10 DEG. IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R