BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT M/S PSL SHELL 52MM1

    MDR report key: 1851070 · Received September 29, 2010

    Report

    Report Number
    2249697-2010-01293
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K903636
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE ABOVE IMPLANTS WERE EXPLANTED DUE TO LOOSENING OF THE ACETABULAR SHELL. THE EXISTING OMNIFLEX HIP STEM WAS FOUND TO BE WELL FIXED AND REMAINED IN PLACE. THE ACETABULAR SHELL AND INSERT WERE REPLACED WITH IMPLANTS FROM ANOTHER COMPANY. THE C-TAPER HEAD WAS REPLACED WITH A UNIVERSAL C-TAPER ADAPTOR SLEEVE # (B)(4) (LOT 32797001) TO AND A BIOLOX 40MM UNIVERSAL HEAD # (B)(4) (LOT# 33784601)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT M/S PSL SHELL 52MM1 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA LE3142

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention