BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY ASR SLEEVE

    MDR report key: 2882475 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-28473
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 19, 2012
    Report Date
    December 3, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    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

    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 PATIENT HAD INCREASED PAIN, IMPAIRING ABILITY TO PERFORM DAILY ACTIVITIES, SLEEP AND WALK; AND ELEVATED BLOOD METAL ION LEVELS AFTER ASR HIP IMPLANT. (B)(6) 2012 - PATIENTS OPERATIVE RECORDS RECEIVED. RECORDS INDICATE CORROSION UPON REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR SLEEVE SLEEVE KWA DEPUY INTERNATIONAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1