BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 3203343 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20440
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    July 1, 2013
    Report Date
    September 20, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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. 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.

    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

    PATIENT UNDERWENT REVISION PROCEDURE DUE TO PAIN.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART & LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. COMPLAINT WAS UPDATED ON (B)(4) 2013.

    Description of Event or Problem · 1

    **UPDATE**(B)(4) - 2013 LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES ELEVATED METAL ION LEVELS, IMPLANT FAILURE, AND BONE AND TISSUE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301871 ASR ACETABULAR CUPS 52 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2441598

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention