BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 3121741 · Received May 21, 2013

    Report

    Report Number
    1818910-2013-05969
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    February 2, 2011
    Report Date
    May 4, 2015
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. NO DEVICES ASSOCIATED WITH THIS REPORT WERE RETURNED. 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 WWCAPA (B)(4) SUPERSEDED BY MDD CAPA-(B)(4). THE PATIENT WAS INITIALLY IMPLANTED WITH DEPUY DEVICES IN APRIL 2009 AND REVISED FOR INFECTION IN FEBRUARY 2011. IT IS NOT LIKELY OR REASONABLE TO CONCLUDE THE DEPUY DEVICES CONTRIBUTED TO THE PATIENT'S REPORTED INFECTION ALMOST TWO YEARS POST PRIMARY IMPLANTATION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE.

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGED: EXCESSIVE LEVELS OF CHROMIUM AND COBALT. PATIENT FACT SHEET FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223640 ASR UNI FEMORAL IMPL SIZE 53 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2814478

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention