BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY

    MDR report key: 2181703 · Received July 22, 2011

    Report

    Report Number
    2181703
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 21, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    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

    MALE PT STATUS POST RIGHT THA DONE WITH A ASR HIP REPLACEMENT SYSTEM MANUFACTURED BY DEPUY WHICH HAS BEEN RECALLED. THE PATIENT COMPLAINED OF INCREASING PAIN THAT WAS NOT RELIEVED BY ANTIINFLAMMATORY MEDS. HIS ACETABULAR COMPONENT WAS NOTED TO BE VERTICALLY ORIENTED AND HE HAD A SOFT TISSUE CYST IN THE ILEOPSOAS MUSCLE ANTERIORLY. HIS METAL ION LEVELS SHOW A CHROME LEVEL OF 2.5 AND A COBALT LEVEL OF 14. HE WAS ADMITTED FOR A REVISION OF HIS HIP REPLACEMENT ACETABULAR COMPONENT. IT WAS NOTED BY THE SURGEON IN PROCEDURE THAT THERE WAS A SIGNIFICANT AMOUNT OF NECROTIC DEBRIS INSIDE THE HIP JOINT. THERE WAS NOTED TO BE SOME GRAYISH STAINED FLUID.THE ACETABULAR COMPONENT WAS NOT GROSSLY LOOSE, BUT WAS EASILY REMOVED WITHOUT ANY EVIDENCE OF BONE INGROWTH WITH USE OF A QUARTER-INCH OSTEOTOME. ON MRI PREOPERATIVELY THE PATIENT HAD A LARGE CYST IN THE ILIOPSOAS MUSCLE. I PUT MY FINGER UP THERE. I COULD EASILY PALPATE THE CYST EXTENDING FROM THE HIP JOINT. THERE WAS NO SIGNIFICANT AMOUNT OF LOOSE MATERIAL. I DID USE A CURETTE AND CURETTED THIS AREA GENTLY, BUT NO SIGNIFICANT MATERIAL CAME OUT OF THE CYST. I DID NOT EXTEND THE DISSECTION IN THIS AREA. I THOUGHT THAT WITH REMOVAL OF THE METAL PRODUCING ELEMENT OF THE HIP THIS WOULD GRADUALLY RESOLVE. THE PATIENT TOLERATED THE PROCEDURE WELL. HE WAS LATER DISCHARGED. ALL NOTES ABOVE PER SURGEON IN MEDICAL RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY DEPUY ASR ACETABULAR COMPONENT KWA DEPUY ORTHOPAEDICS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR