BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR TAP SLV ADAP 12/14 -1

    MDR report key: 4233790 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31387
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    December 2, 2014
    Report Date
    March 23, 2015
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK070359
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. REF. WWCAPA (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. (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN, DIFFICULTY WALKING, VERTIGO, DIFFICULTY SLEEPING, ELEVATED LEVELS OF CHROMIUM AND COBALT, A METAL TASTE IN HER MOUTH, PSEUDOTUMOR, AND METAL SHAVINGS AROUND THE IMPLANT AREA.

    Description of Event or Problem · 1

    UPDATE REC¿D 03/23/2015 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOR 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: 03/30/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714721 ASR TAP SLV ADAP 12/14 -1 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTL., LTD. - 8010379 2452905

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R