BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 55

    MDR report key: 2093834 · Received May 12, 2011

    Report

    Report Number
    1818910-2011-08092
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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. 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.

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, DEVICE PRODUCT CODE, CATALOG #/LOT #, PMA/510(K) #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS AND OSTEOLYSIS. UPDATE - (B)(4) 2012 - LITIGATION PAPERS WERE RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE- (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED CORRECT PART/LOT INFORMATION FOR THE FEMORAL HEAD. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 55 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2088204

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention