BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA C-TAPER HEAD 28MM/0

    MDR report key: 1833113 · Received September 9, 2010

    Report

    Report Number
    9616680-2010-00554
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 24, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K971409
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ALL REVISED COMPONENTS WERE DISPOSED OF. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DR. EXPLAINED THAT PT DESCRIBED TO STAFF A UNIQUE FEELING NEAR HIP SEVERAL DAYS PRIOR TO COMING TO ER. SHE FELT THIS GETTING IN OR OUT THE CAR. DR. DETERMINED VIA X-RAY OVERVIEW NEED FOR FEMORAL HEAD REVISION. EXISTING ACETABULAR COMPONENT WAS REMOVED. TRIDENT (B)(4), (B)(4), (B)(4) AND (B)(4) WERE USED AS A REVISION COMPONENTS IN AN UNEVENTFUL REVISION PROCEDURE. THE EXISTING C-TAPER SLEEVE REMAINED ON EXISTING STEM SO C-TAPER HEAD USED FOR REVISION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA C-TAPER HEAD 28MM/0 IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 23900801

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention