BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL HEAD

    MDR report key: 2210493 · Received August 9, 2011

    Report

    Report Number
    1818910-2011-15132
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    July 22, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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).

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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 INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    MALE PT - (B)(6) WAS PRESENTED WITH A DIAGNOSIS OF CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL). PT HAD BILATERAL ASR HIPS IMPLANTED SIX YEARS AGO ASR RESURFACING AND AN ASR XL WITH CORAIL STEM. SURGEON'S INTERNAL ASSESSMENT IS THAT FROM THE POSITION OF THE ASR RESURFACING HEAD ON X-RAY IT APPEARS THAT THERE HAS BEEN EDGE LOADING AND SUBSEQUENT WEAR. CHROMIUM AND COBALT BLOOD LEVELS ARE 800 AND 1300 MMOL/L RESPECTIVELY. CAUSALITY ASSESSMENT BY SURGEON/ONCOLOGIST IS THAT THE CLL IS POSSIBLY RELATED TO THE HIGH CHROMIUM AND COBALT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR XL HEAD TOTAL HIP PROSTHESIS KXA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention