BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 1954409 · Received January 5, 2011

    Report

    Report Number
    1818910-2010-10811
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 6, 2010
    Report Date
    February 27, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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. 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A LOT SPECIFIC COMPLAINT DATABASE SEARCH AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE NECESSARY LOT CODES WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. ALTHOUGH THE ROOT CAUSE CANNOT BE DETERMINED, IT IS KNOWN THAT THE ASR PLATFORM WAS VOLUNTARILY RECALLED IN AUGUST OF 2010 FOLLOWING AN HHE (HEALTH HAZARD EVAL). FURTHER ANALYSIS REGARDING THE ASR PRODUCT FAMILY WILL BE DOCUMENTED, AS DETERMINED PERTINENT, IN (B)(4) AND (B)(4). BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO 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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    UPDATE: 2/27/2014 LITIGATION RECEIVED. LITIGATION ALLEGES DIFFICULTY AMBULATING AND ELEVATED METAL ION LEVELS FOUND WITHIN FLUID ASPIRATED DURING REVISION SURGERY. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 03/19/2014.

    Description of Event or Problem · 1

    PT REVISED FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 49 87 KWA KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention