BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR CUP

    MDR report key: 2052695 · Received April 7, 2011

    Report

    Report Number
    1818910-2011-06021
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 13, 2026
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    BILATERAL PT. LITIGATION PAPERS ALLEGE ACETABULAR CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM PT'S ACETABULUM, CAUSED SEVERE PAIN, INHIBITED PT'S ABILITY TO WALK, AND CAUSED ELEVATED BLOOD LEVELS OF CHROMIUM AND COBALT. IT IS FURTHER ALLEGED THAT PT IS SCHEDULED TO UNDERGO REVISION SURGERIES OF THE RIGHT AND LEFT HIP ON OR ABOUT (B)(6), 2011 AND (B)(6), 2011, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR CUP NONE KWA DEPUY INTERNATIONAL, LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention