BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2230375 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17031
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    March 27, 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
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT EXPERIENCED PAIN IN THE RIGHT HIP RADIATING INTO THE RIGHT KNEE AND PAIN AND SWELLING OF THE RIGHT KNEE, THIGH, AND LOWER BACK, MAKING IT DIFFICULT AND PAINFUL FOR HIM TO WALK OR PERFORM ANY PHYSICAL ACTIVITY. IT IS FURTHER ALLEGED THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION THE CUP WAS FOUND TO HAVE ONLY FIBROUS INGROWTH.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL 2959900

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention