BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 3801008 · Received May 8, 2014

    Report

    Report Number
    1818910-2014-18400
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    July 5, 2010
    Report Date
    April 21, 2014
    Manufacturer
    DEPUY INTL., LTD - 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. 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 THIS 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 ALLEGES PAIN, DISCOMFORT, SWELLING, DECREASED RANGE OF MOTION, DETERIORATION OF THE SOFT TISSUE, AND ELEVATED METAL ION LEVELS. PPD ALSO RECEIVED ON (B)(6) 2014. COMMENT: THERE IS A DOR DISCREPANCY BETWEEN LITIGATION AND THE PPD. DUE TO ACCURACY, THE DOR FROM THE PPD WILL BE REPORTED. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277673 UNKNOWN DEPUY ASR FEMORAL HEAD HIP FEMORAL HEAD KXA DEPUY INTL., LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention