BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 3050023 · Received April 10, 2013

    Report

    Report Number
    1818910-2013-06509
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    May 9, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    UPDATE (B)(4) 2013 - SALES REP REPORTED REVISION SURGERY ON RIGHT HIP DUE TO UNKNOWN REASON. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DOR: (B)(6) 2013 (RIGHT HIP).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PERSISTENT SEVERE PAIN AND DISCOMFORT IN HIS HIPS, AND THIGH, WHICH HAS INCREASED OVER TIME; SKIN RASHES AND SENSITIVITY; CLICKING AND POPPING OF HIPS; LIMITED RANGE OF MOTION AND SUBSTANTIALLY ELEVATED LEVELS OF COBALT AND CHROMIUM METAL IONS IN HIS BLOODSTREAM. UPDATE: (B)(4) 2013 - SALES REP REPORTED REVISION SURGERY DUE TO PAIN, ABNORMAL MRI, AND ELEVATED ION LEVELS. PART/LOT WERE IDENTIFIED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(4) 2013 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS IDENTIFIED PART/LOT FOR THE RIGHT HIP. MEDICAL RECORDS ALSO NOTED INTEROPERATIVE FINDING OF THE LEFT HIP REVISION SURGERY NOTED MINIMAL CORROSION ALONG THE FEMORAL NECK. THE STEM AND SLEEVE WERE ADDED TO THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149255 ASR ACETABULAR CUPS 60 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2602545

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention