BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSL HA SCREWLESS ACET SHELL

    MDR report key: 2084828 · Received April 29, 2011

    Report

    Report Number
    2249697-2011-00605
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K911728
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 2044-2654, LOT # UNK, DESCRIPTION: OMNIFIT SER II INSERT -10 DEG. CAT # 06-2605, LOT # 1337540, DESCRIPTION: C-TAPER COCR LFIT HEAD 26MM/+5. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SURGEON REMOVED THE HEAD, CUP AND LINER. HE THEN REPLACED WITH A 56MM PSL CLUSTER CUP WITH MULTIPLE SCREWS AND A 10 DEG 36MM X3 LINER AND A 36 +5 C-TAPER HEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSL HA SCREWLESS ACET SHELL IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 12681701

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R