BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR ACETABULAR CUP

    MDR report key: 2922296 · Received January 11, 2013

    Report

    Report Number
    MW5028632
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    April 5, 2007
    Report Date
    January 11, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TOTAL HIP REPLACEMENT OF LEFT HIP (B)(6) 2007 WITH DEPUY ASR: ACETABULAR CUP SIZE 54, UNI FEMORAL IMPLANT SIZE 47. TAPER SLEEVE ADAPTOR +5 BLOOD CLOT AND READMITTED FOR SEVERAL DAYS. TREATED FOR APPROX. 6 MONTHS. AFTER POST OP. HEALING STILL EXPERIENCED PAIN AND REDUCED RANGE OF MOTION. PAIN LIMITED WALKING ON FLAT GROUND OR STAIRS. SLEEPING AND SITTING WAS UNCOMFORTABLE. GETTING IN AND OUT OF CARS PAINFUL. MOST EXERCISE DIFFICULT. OTC MEDS. WERE INEFFECTIVE. LOST OVERALL STRENGTH. AFTER APPROX. 2 YEARS WITHOUT SUCCESS WITH ORIGINAL DR, SOUGHT OUT ANOTHER OPTION. NEW SURGEON DISCOVERED MASSES AND DETERMINED THAT A REVISION WAS REQUIRED. TOTAL RIGHT HIP REPLACEMENT ON (B)(6) 2007 WITH DEPUY ASR: ACETABULAR CUP SIZE 54 UNI FEMORAL IMPLANT SIZE 47. TAPER SLEEVE ADAPTOR +5. REVISION OF LEFT HIP (B)(6) 2010. BLOOD CLOT FOLLOWING SURGERY. EXTENDED HOSPITAL STAY AND TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18866 DEPUY ASR ACETABULAR CUP ASR TOTAL HIP KWA DEPUY ORTHOPAEDICS DEPUY ASR 2297151
    18867 DEPUY ASR UNIFEMORAL ASR TOTAL HIP KWA DEPUY ORTHOPAEDICS DEPUY ASR BA2AR1000
    18868 DEPUY ASR TAPER SLEEVE ADAPTOR ASR TOTAL HIP KWA DEPUY ASR

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other