BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 4133881 · Received October 2, 2014

    Report

    Report Number
    1818910-2014-29249
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 24, 2014
    Report Date
    December 19, 2014
    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
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    ASR REVISION REPORTED VIA SALES REP.ASR XL.LEFT.LITIGATION PAPERS ALLEGE PAIN, STIFFNESS, DISFIGUREMENT, AND BODILY INJURY.PATIENT HAD HIP REVISION FOR ASR HIP. PT HAS HAD COBALT / CHROMIUM LEVELS AND PAIN. IMPLANTS REMOVED AND NEW CUP, LINER AND HEADBALL IMPLANTED.

    Description of Event or Problem · 1

    UPDATE REC'D 12/19/2014 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 01/14/2015.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN, STIFFNESS, DISFIGUREMENT, AND BODILY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614427 ASR UNI FEMORAL IMPL SIZE 51 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2923453

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other