BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY ASR HIP IMPLANT

    MDR report key: 2250824 · Received September 1, 2011

    Report

    Report Number
    2250824
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 25, 2011
    Report Date
    September 1, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS ADMITTED FOR A REVISION OF A LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT HAD A RECALLED DEPUY ASR HIP IMPLANT. THE FOLLOWING IS EXCERPTED FROM THE MEDICAL RECORD. SERIAL RADIOGRAPHS REVEALED ASEPTIC LOOSENING AND A PROTUSIO DEFECT OF THE LEFT ACETABULAR COMPONENT. THE SURGICAL NOTE FROM THE PHYSICIAN REPORTED NO METALLOSIS, NO MILKY FLUID IDENTIFIED UPON EXAMINATION OF THE HIP AND SOFT TISSUES. THERE WAS ONLY FIBROUS GROWTH. A SMALL GOUGE WAS USED TO LOOSEN THE FIBROUS TISSUE SUPERIORLY, AND THEN THE CUP WAS EASILY REMOVED FROM THE ACETABULAR BED. THE BONE WAS QUITE SCLEROTIC. REAMING WAS PERFORMED TO GET A GOOD CONCENTRIC ANTIPROTRUSIO TECHNIQUE BLEEDING RIM OF BONE. THE CENTRAL SCLEROTIC BONE WAS LEFT, AS IT WAS ALREADY IN A PROTRUSIO POSITION. A TRIAL ACETABULAR CUP WAS PLACED AND THERE WAS GOOD COVERAGE. THE FINAL TRABECULAR METAL 56 MM ACETABULAR SHELL WAS IMPACTED IN ABOUT 40-TO-45-DEGREES OF ABDUCTION AND ABOUT 20-DEGREES OF ANTEVERSION....A BIOLOX DELTA HEAD WAS CHOSEN, AS THERE WAS NO COBALT AND CHROMIUM PRESENT. THE GROSS DESCRIPTION FROM PATHOLOGY IS AS FOLLOWS: THE SPECIMEN IS RECEIVED IN FIXATIVE LABELED "LEFT HIP PROSTHESIS" AND CONSISTS OF A METAL ARTIFICIAL FEMORAL HEAD WITH SCANT ATTACHED CEMENT, BUT NO SOFT TISSUE. THERE IS LABELING INSIDE THE SPECIMEN WHICH CANNOT BE READ. LEFT HIP CAPSULE: HIP CAPSULE WITH FIBROSIS AND MILD CHRONIC INFLAMMATION ORGANIZING FIBRIN WITH A FEW NEUTROPHILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR HIP IMPLANT DEPUY ASR HIP IMPLANT KWA DEPUY ORTHOPAEDICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR