BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT HA PSL CUP/CLUSTER SHELL 50MM

    MDR report key: 2012914 · Received March 1, 2011

    Report

    Report Number
    2249697-2011-00227
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DR REMOVED CUP/LINER HEAD. REPLACED TRIATANIUM 54MM REVISION CUP, 36MM 0 (DEGREE) X3 LINER AND A 36 AND 10 METAL HEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECUR-FIT HA PSL CUP/CLUSTER SHELL 50MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 44193101

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R