BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2153096 · Received May 25, 2011

    Report

    Report Number
    1818910-2011-09227
    Event Type
    Injury
    Date Received
    May 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CORRECTED: CORRECTION/REMOVAL REPORTING NUMBER. 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE IN OR AROUND (B)(6) 2010, PATIENT'S PHYSICIAN ORDER PATIENT TO UNDERGO BLOOD TESTS WHICH SHOWED THAT SHE HAD HIGH LEVELS OF THE METALS CHROMIUM AND COBALT IN HER BLOOD, REQUIRING REVISION SURGERY TO REPLACE THE ASR XL ACETABULAR SYSTEM. UPDATE: (B)(6) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION, DATE OF IMPLANT AND DATE OF EXPLANT. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE OR AROUND (B)(6) 2010, PT'S PHYSICIAN ORDER PT TO UNDERGO BLOOD TESTS WHICH SHOWED THAT SHE HAD HIGH LEVELS OF THE METALS CHROMIUM AND COBALT IN HER BLOOD, REQUIRING REVISION SURGERY TO REPLACE THE ASR XL ACETABULAR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 NONE KWA DEPUY INTERNATIONAL, LTD. NA 2574555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention