BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 3141189 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-17999
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    December 5, 2013
    Report Date
    March 6, 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
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT HAD HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS.

    Description of Event or Problem · 1

    UPDATE: 3/6/2014 - MEDICAL RECORDS RECEIVED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 03/17/2014.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - SALES REP REPORTED REVISION SURGERY. PART AND LOT INFORMATION RETRIEVED FROM INVOICE. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243024 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2969524

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other