BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA ACETABULAR CUP

    MDR report key: 1772133 · Received July 22, 2010

    Report

    Report Number
    2249697-2010-00871
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 29, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWB
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO WAS PROVIDED BY STRYKER ORTHOPAEDICS' CLINICAL AFFAIRS DEPT. NO ADD'L INFO IS AVAILABLE AT THIS TIME. ADD'L F/U INFO MAY BE OBTAINED BY THE CLINICAL AFFAIRS AS IT BECOMES AVAILABLE. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SITE INDICATED THAT A SUBJECT BEING ENROLLED IN THE TRIDENT TRITANIUM ACETABULAR SHELL REVISION STUDY, (B)(4), HAD PREVIOUS STRYKER IMPLANTS. PROGRESSIVE PAIN AND ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA ACETABULAR CUP IMPLANT KWB STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R