BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 3260660 · Received August 1, 2013

    Report

    Report Number
    1818910-2013-22810
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    September 16, 2013
    Report Date
    November 3, 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.(B)(4). 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. 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

    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. (B)(4).

    Description of Event or Problem · 1

    LITIGATION RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM ELEVATED CHROMIUM AND COBALT LEVELS.

    Description of Event or Problem · 1

    UPDATE REC'D 10/17/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, SORENESS, DIFFICULTY WALKING, AND ELEVATED METAL IONS. THE DOB & DOR WERE PROVIDED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT.THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 11/13/2014.

    Description of Event or Problem · 1

    UPDATE REC'D 11/03/2014 - 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: 12/01/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360469 ASR UNI FEMORAL IMPL SIZE 43 FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2385723

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other