BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT HA PSL SCREWLESS CUP 60MM

    MDR report key: 2115315 · Received May 27, 2011

    Report

    Report Number
    2249697-2011-00778
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K942900
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 2041-2858, LOT # 1PLFH, DESCRIPTION: OMNIFIT SER II INSERT-10 DEG. CAT # 06-2800, LOT # 29613601, DESCRIPTION: C-TAPER COCR LFIT HEAD 28MM/0. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON'S ASSESSMENT; PT HAD PAINFUL LEFT HIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECUR-FIT HA PSL SCREWLESS CUP 60MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 27280302

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R