BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF HIP STEM #3

    MDR report key: 2547776 · Received April 20, 2012

    Report

    Report Number
    9616680-2012-00293
    Event Type
    Injury
    Date Received
    April 20, 2012
    Date of Event
    March 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: DESCRIPTION: STD MITCH TRH CP (B)(4), CAT #: MAC-9988-4450, LOT #: FM063935, MANUFACTURER: DEPUY. DESCRIPTION: MITCH TRH MD HD (B)(4), CAT #: MMH-9988-0444, LOT #: FM071545, MANUFACTURER: DEPUY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ACCOLADE STEM SIZE 3/132 DEGREE WITH MITCH CUP 50MM/44MM HEAD WAS REVISED AS A RESULT OF A PERIPROSTHETIC FRACTURE. IT WAS NOTED BY THE SURGEON AT THE TIME OF EXTRACTING THE COMPONENTS THAT THERE WAS NO BONE ON GROWTH AND THERE WAS A REASONABLE AMOUNT OF WEAR DEBRIS AROUND THE ACETABULUM. A REVISION HIS SURGERY WAS PERFORMED USING A RESTORATION STEM WITH A TRILOGY CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE TMZF HIP STEM #3 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 26505706

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R