BEUDAMED
    FDA Adverse Event Other Summary report: N

    KERAMOS CERAMIC ON CERAMIC FLARED RIM SHELLS

    MDR report key: 1100432 · Received August 6, 2008

    Report

    Report Number
    1644408-2008-00252
    Event Type
    Other
    Date Received
    August 6, 2008
    Date of Event
    July 3, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT WAS ADMITTED FOR REVISION OF RIGHT TOTAL HIP, SECONDARY TO PAIN AND INFECTION WITH STAPH AUREUS. EXPLANTED DEVICES INCLUDED AN APEX HIP STEM, A HEAD OF UNKNOWN MANUFACTURE, AND AN ENCORE FLARED RIM AL-AL CUP, AND AN ENCORE AL-AL LINER. REPORTED TO ENCORE VIA A VOLUNTARY MEDWATCH FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERAMOS CERAMIC ON CERAMIC FLARED RIM SHELLS ACETABULAR SHELL KWB ENCORE MEDICAL, L.P. 53866549

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 498-32-052/53876113