BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR ACETABULAR CUP

    MDR report key: 2760842 · Received September 26, 2012

    Report

    Report Number
    1818910-2012-75574
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. (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.

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT CHANGES THE OUTCOME OF THE INVESTIGATION. DEPUY STILL 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

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED PAIN.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS SUFFERED SEVERE AND POSSIBLY PERMANENT INJURIES, DISABILITY, DISFIGUREMENT, PAIN AND SUFFERING AND EXPOSURE TO HIGH LEVELS OF COBALT AND CHROMIUM AS A RESULT OF IMPLANTATION WITH THE ASR HIP IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR ACETABULAR CUP TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other