BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 3030106 · Received April 2, 2013

    Report

    Report Number
    1818910-2013-04376
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    November 13, 2012
    Report Date
    January 10, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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

    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.

    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. REF. (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

    PATIENT WAS REVISED DUE TO ELEVATED METAL ION LEVELS AND MODERATE DISCOMFORT. (B)(6) 2013 - PATIENTS OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS A PAINFUL PSEUDOCYST. UPON REVISION BROWN TISSUE WAS FOUND LINING THE CYST. CYSTIC TISSUE WAS ALSO DISSECTED OUT. CORROSION WAS FOUND AROUND THE TAPER OF THE STEM AS WELL.

    Description of Event or Problem · 1

    UPDATE REC¿D 1/10/2014 - LEGAL CLAIM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 08/19/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134089 ADAPTER SLEEVES 12/14 +2 SLEEVE KWA DEPUY INTERNATIONAL 2987979

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR