BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HEAD

    MDR report key: 2113327 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08938
    Event Type
    Injury
    Date Received
    May 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE: IN (B)(6) 2008, PATIENT UNDERWENT A SURGICAL PROCEDURE TO IMPLANT A DEPUY ASR HIP. BY 2009, PATIENT BEGAN SUFFERING FROM DISCOMFORT AND PAIN IN HIS HIP, AS WELL AS EXPERIENCING PAIN AND POPPING IN THE JOINT AREA. IN (B)(6) 2010, HE WAS FOUND TO HAVE HIGH BLOOD LEVELS OF CHROMIUM AND COBALT, AS WELL AS A BUILD-UP OF FLUID AROUND THE IMPLANT SITE. IN (B)(6) 2011, PATIENT UNDERWENT REVISION SURGERY. DOI: (B)(6) 2008 - DOR: (B)(6) 2011. PATIENT RESIDES IN (B)(6). UPDATE 3/15/2011 - MEDICAL RECORDS RECEIVED BY BROADSPIRE, FORWARDED TO DEPUY ON 5/17/2011. REVISION OPERATIVE REPORT INDICATES THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND INCREASED METAL ION LEVELS. DURING SURGERY, CORROSION WAS NOTED ON THE TRUNNION OF THE STEM. DOI: (B)(6) 2008 - DOR: (B)(6) 2011 (RIGHT SIDE). 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

    LITIGATION PAPERS ALLEGE: IN (B)(6) 2008, PATIENT UNDERWENT A SURGICAL PROCEDURE TO IMPLANT A DEPUY ASR HIP. BY 2009, PATIENT BEGAN SUFFERING FROM DISCOMFORT AND PAIN IN HIS HIP, AS WELL AS EXPERIENCING PAIN AND POPPING IN THE JOINT AREA. IN (B)(6) 2010, HE WAS FOUND TO HAVE HIGH BLOOD LEVELS OF CHROMIUM AND COBALT, AS WELL AS BUILD-UP OF FLUID AROUND THE IMPLANT SITE. IN (B)(6) 2011, PATIENT UNDERWENT REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention