BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 3160258 · Received June 10, 2013

    Report

    Report Number
    1818910-2013-18528
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 29, 2013
    Report Date
    March 12, 2015
    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
    SC, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN AND ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE REC'D 03/12/2015- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, DISCOMFORT, FLUID, AND INCREASING TOXIC METAL ION LEVELS, INCLUDING A COBALT LEVEL OF 18.4 PPB AND A CHROMIUM LEVEL OF 3.0 PPB. THE DOB AND DOI WERE PROVIDED. THE STEM AND SLEEVE ARE BEING REPORTED DUE TO ELEVATED METAL ION LEVELS. THE COMPLAINT WAS UPDATED ON: 03/17/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260495 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2334140

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention