BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM +16 V40 TAPER VIT HEAD

    MDR report key: 1442222 · Received August 14, 2009

    Report

    Report Number
    9616680-2009-00349
    Event Type
    Injury
    Date Received
    August 14, 2009
    Date of Event
    July 29, 2009
    Report Date
    July 29, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    K993601
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. 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 THAT, IT WAS ALLEGED THAT, "THE PT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT SURGERY IN 1998 AT THE HOSPITAL." IT WAS FURTHER ALLEGED THAT, "IN 2003, THE FEMORAL HEAD COMPONENT IN THE RIGHT HIP PROTHESIS FAILED AND PT WAS OPERATED ON AGAIN ON THE SAME MONTH." IT WAS FURTHER ALLEGED THAT, "IN 2006, THE RIGHT HIP PROSTHESIS FAILED AND THE PT AGAIN UNDERWENT SURGERY THE SAME MONTH, WITH A TOTAL REPLACEMENT OF ALL THE PROSTHETIC PARTS IN HER RIGHT HIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 28MM +16 V40 TAPER VIT HEAD IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA 5953431

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention