BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #3

    MDR report key: 2077841 · Received April 27, 2011

    Report

    Report Number
    9616680-2011-00252
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    May 16, 2006
    Report Date
    April 11, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PT, AS A RESULT OF A LEGAL CLAIM, THAT, "ON (B)(6), 2006, THE PT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT SURGERY. THE COMPONENTS IMPLANTED IN THE PT WERE: ZIMMER SHELL, ZIMMER POLY LINER, ZIMMER BONE SCREW, HOC ACCOLADE TMZF PLUS HIP STEM #3 (B)(4), AND HOC V40 FEMORAL HEAD (B)(4). "IT WAS FURTHER REPORTED THAT; "THE PT UNDERWENT A REVISION SURGERY ON (B)(6), 2009, DUE TO ASEPTIC LOOSENED ACETABULAR COMPONENT AND POSSIBLE INFECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE PLUS TMZF HIP STEM #3 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 17861002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention