BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVES 12/14 +8

    MDR report key: 2921089 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-11142
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    November 15, 2012
    Report Date
    July 2, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    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 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

    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

    PATIENT WAS REVISED DUE TO MODERATE DISCOMFORT AND HIGH METAL LEVELS. (B)(4) 2012 - PATIENT'S MEDICAL RECORDS RECEIVED. RECORDS INDICATE UPON REVISION MILD CORROSION WAS FOUND AROUND THE TAPER AND STEM.

    Description of Event or Problem · 1

    UPDATE REC¿D 7/2/2014 - LITIGATION RECEIVED. LITIGATION ALLEGES PAIN, TAN AND DARKER TAN TISSUE SURROUNDING THE HIP JOINT, METALLOSIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 07/15/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26074 ADAPTER SLEEVES 12/14 +8 SLEEVE KWA DEPUY INTERNATIONAL, LTD. 2844718

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR