BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF HIP STEM #4

    MDR report key: 3150695 · Received June 6, 2013

    Report

    Report Number
    0002249697-2013-01851
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    LOT #, STERI LOT, EXPLANT DATE, AND MANUFACTURING DATE WERE UPDATED. AN EVENT REGARDING INFECTION INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN ONE OTHER EVENT FOR THE REPORTED LOT AND NO OTHER EVENT STERILE LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

    SURGEON REVISED ACCOLADE/MITCH. REMOVED HEAD FOUND EXTENSIVE BLACK PARTICULATE MATERIAL IN TISSUE & SURROUNDING TRUNNION. PASTY CREAM PUS LIKE MATERIAL REPORTED TO BE PRESENT IN TISSUE ALSO. SURGEON SUSPECTED INFECTION & TOOK SWABS. STEM NOTED TO BE LOOSE BUT HUNG UP IN FEMUR & ONLY HEAD WAS REMOVED & REPLACED WITH A SPACER. SURGEON BOOKED PATIENT IN FOR 2ND STAGE REVISION OF STEM ON (B)(6). STEM LEFT INSITU. MITCH 58MM, SZ4 ACCOLADE, IMPLANTED (B)(6).

    Description of Event or Problem · 1

    SURGEON REVISED ACCOLADE/MITCH. REMOVED HEAD FOUND EXTENSIVE BLACK PARTICULATE MATERIAL IN TISSUE AND SURROUNDING TRUNNION. PASTY CREAM PUS LIKE MATERIAL REPORTED TO BE PRESENT IN TISSUE ALSO. SURGEON SUSPECTED INFECTION AND TOOK SWABS. STEM NOTED TO BE LOOSE BUT HUNG UP IN FEMUR AND ONLY HEAD WAS REMOVED AND REPLACED WITH A SPACER. SURGEON BOOKED PATIENT IN FOR 2ND STAGE REVISION OF STEM ON (B)(6). STEM LEFT INSITU. MITCH 58MM, SZ4 ACCOLADE, IMPLANTED (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249990 ACCOLADE TMZF HIP STEM #4 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 28169003

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O| R