BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVES 12/14 +5

    MDR report key: 3920950 · Received July 8, 2014

    Report

    Report Number
    1818910-2014-23009
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.-8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    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. (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. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION PAPERS ALLEGE: SUFFERED BODILY INJURY, PAIN AND SUFFERING DISABILITY, MENTAL ANGUISH, MEDICAL EXPENSE IN THE PAST AND IN THE FUTURE, PERMANENT INJURIES, LOSS OF EARNINGS, DISFIGUREMENT, AND LOSS OF THE CAPACITY FOR THE ENJOYMENT OF LIFE. DOI: (B)(6) 2007 LEFT HIP; DOR: UNK. (B)(6). UPDATE (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE (B)(4) 2014 - ADDED TAPER SLEEVE AND ALSO CORROSION AS A REASON FOR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398378 ADAPTER SLEEVES 12/14 +5 HIP OTHER IMPLANT KWA DEPUY INTERNATIONAL LTD.-8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR