BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO 4

    MDR report key: 1080485 · Received July 22, 2008

    Report

    Report Number
    9610669-2008-00016
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 25, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CAEN
    Product Code
    KWY
    PMA / PMN Number
    K011623
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. NO INFORMATION WAS PROVIDED ABOUT THE REVISED STEM, THE REASON FOR THE REVISION OR THE DEVICES USED FOR REAMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A REVISION OF A LEFT HIP (PRODUCT NOT SPECIFIED), THE FEMUR BROKE ABOUT 1/3RD OF THE WAY UP FROM THE BASE OF THE KNEE WHILE REAMING OUT THE PROXIMAL CANAL TO REMOVE THE EXISTING CEMENT MANTLE. THE SURGEON IMPLANTED A STANDARD EXETER STEM. THERE WAS GROSS LAXITY OF THE SOFT TISSUES AT THE HIP SITE, SO A TRITANIUM SHELL WITH A 36MM ECCENTRIC INSERT WAS IMPLANTED TO HELP COMPENSATE FOR THE LAXITY. AN EXETER +5 HEAD WAS ALSO USED. THE HIP WAS STILL GROSSLY UNSTABLE. THE FRACTURE WAS PLATED AND CABLED, BUT IT WAS DETERMINED THAT THE HIP WAS STILL UNACCEPTABLE. THE SURGEON ELECTED TO IMPLANT A +10 LFIT HEAD EVEN THOUGH THE ALLOY IS NOT COMPATIBLE WITH THE EXETER STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER V40 STEM 44MM NO 4 IMPLANT KWY STRYKER ORTHOPAEDICS CAEN NA G1850712

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention