BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVE 11/13 +3

    MDR report key: 3771563 · Received April 24, 2014

    Report

    Report Number
    1818910-2014-17457
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 18, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK070359
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    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 ALLEGES PAIN, METALLOSIS, TISSUE AND FLUID FORMATION, DIFFICULTY WALKING AND ELEVATED METAL ION LEVELS. UPDATE REC'D (B)(4) 2014 - MEDICAL RECORDS RECEIVED. UPON REVISION METAL DARK STAINING, BLACK-STAINED TISSUE WITHIN THE JOINT, AND CORROSION WERE FOUND. THE SLEEVE, STEM SLEEVE, AND STEM ARE NOW BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249116 ADAPTER SLEEVE 11/13 +3 HIP OTHER IMPLANT KWA DEPUY INTERNATIONAL LTD. 1990625

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other