BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 2192462 · Received July 8, 2011

    Report

    Report Number
    1818910-2011-12569
    Event Type
    Injury
    Date Received
    July 8, 2011
    Report Date
    April 2, 2013
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    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

    THIS IS A DUPLICATE REPORT OF 1818910-2012-22446. THIS REPORT, 1818910-2011-12569, WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2012-22446.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP WAS MADE IN ERROR.

    Additional Manufacturer Narrative · 1

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

    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).

    Description of Event or Problem · 1

    **UPDATE** (B)(6) 2013 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS A GRINDING SENSATION AND ELEVATED IRON LEVELS. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXSISTING MDR DECISION. DOR: (B)(6) 2012 (RIGHT HIP).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE FOLLOWING: ON OR ABOUT (B)(6) 2010, PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: LOWER EXTREMITY SWELLING, HIP PAIN, LOSS OF ENJOYMENT OF LIFE, METALLOSIS EXPOSURE AND OTHER INJURIES PRESENTLY UNDIAGNOSED. PATIENT HAS NOT YET SCHEDULED A SPECIFIC DATE OF EXPLANATION OF THE RIGHT OR LEFT HIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention