BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 3951265 · Received July 22, 2014

    Report

    Report Number
    1818910-2014-23995
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    December 3, 2013
    Report Date
    July 8, 2014
    Manufacturer
    DEPUY INTL., 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
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. (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 ALLEGE PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, AND HIGH LEVELS OF TOXIC METALS IN THE BLOODSTREAM. UPDATE REC¿D (B)(4) 2014 - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS "A LOT OF FLUID AND UGLY TISSUE." THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014. UPDATE REC¿D (B)(4) 2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS A PSEUDOTUMOR. UPON REVISION, GRAY-BROWN FLUID, A THIN FIBROUS WALL, DEFICIENT EXTERNAL ROTATORS, A ¿HOLE¿ IN THE POSTERIOR CAPSULE AND CORROSION ON THE TRUNNION WERE NOTED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427808 ADAPTER SLEEVES 12/14 +2 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTL., LTD. - 8010379 2568305

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR