BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 3073605 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-02869
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    July 19, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION 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. (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 PATIENT UNDERWENT REVISION PROCEDURE OF RIGHT HIP. PART/LOT WAS PROVIDED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT WAS INJURED BY EXCESSIVE BLOOD LEVELS OFCHROMIUM AND COBALT DUE TO THE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175485 ASR ACETABULAR CUPS 52 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2692787

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R