BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN HIP

    MDR report key: 7480633 · Received May 2, 2018

    Report

    Report Number
    0002249697-2018-01321
    Event Type
    Death
    Date Received
    May 2, 2018
    Date of Event
    January 8, 2015
    Report Date
    May 2, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT BEGAN TO EXPERIENCE PAIN AND WAS EVALUATED BY HER PHYSICIANS. SHE UNDERWENT REVISION SURGERY ON (B)(6) 2015 AND DURING THIS PROCEDURE, THE SURGEON "FOUND SIGNIFICANT NECROSIS AND FLUID WITHIN THE HIP AND GLUTEUS MINIMUS. AS HE PERFORMED THE PROCEDURE, HE ENCOUNTERED ADDITIONAL NECROSIS WITHIN THE ABDUCTORS AND SOFT TISSUE, AND THERE WAS CORROSION AND BLACK STAINING UNDER THE BALL AND SURROUNDING TAPER." IT IS FURTHER ALLEGED THAT ON (B)(6) 2015 AS A DIRECT AND PROXIMATE RESULT OF A POST-OPERATIVE INFECTION THAT DEVELOPED AFTER REVISION SURGERY, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323104 UNKNOWN HIP HIP IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death