BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 3972151 · Received July 31, 2014

    Report

    Report Number
    1818910-2014-24726
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 16, 2014
    Report Date
    May 19, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD.-8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. REF. (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. 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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ASR REVISION REPORTED VIA SALES REP, ASR XL, LEFT. REASON(S) FOR REVISION : PAIN / ELEVATED COCR LEVELS / FLUID. THE HEAD AND SLEEVE WERE REVISED WHIST THE CUP AND STEM REMAIN IN SITU. UPDATE: ADDED UNKNOWN CUP AS ADVISED WILL STILL NEED TO BE REPORTED DUE TO THE INCREASED METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE REC'D 5/19/2015 MEDICAL RECORDS RECEIVED FROM LEGAL. PATIENT REVISED TO ADDRESS ADVERSE LOCAL TISSUE RESPONSE AND ELEVATED METAL ION LEVELS (CO 25). UPON REVISION, YELLOWISH-BROWN OPAQUE FLUID AND CORROSION ON THE TRUNNION WERE NOTED. THE STEM REMAINED IN SITU. THE STEM IS BEING ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447591 ADAPTER SLEEVES 12/14 +2 HIP OTHER IMPLANT KWA DEPUY INTERNATIONAL LTD.-8010379 2839242

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention