BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2771228 · Received October 3, 2012

    Report

    Report Number
    1818910-2012-76403
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 5, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    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

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED GREAT PAIN, DISFIGUREMENT, DEFORMITY, NUMEROUS SURGICAL OPERATIONS, DIMINUTION IN THE QUALITY OF HIS LIFE, AND PERMANENT DISABILITY. PAPERS ALSO ALLEGE EXCESSIVE LEVELS OF CHROMIUM AND COBALT BLOOD LEVELS.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED 09/05/2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: PAIN; ELEVATED COBALT AND CHROMIUM ION LEVELS; UNUSUAL RED MACULOPAPULAR RASH OVER THE LEFT HIP; UNUSUAL COLLECTION OF YELLOWISH NONODOROUS FLUID WITH A GRAYISH YELLOW NECROTIC-LOOKING TISSUES WITH ALMOST A CASEOUS APPEARANCE; CASEOUS MATERIAL WAS FAIRLY SUBSTANTIAL; APPEARED TO BE SOME DIFFUSE SCRATCHES ON THE HEAD; EVIDENCE OF SOME BLACKISH CORROSIVE MATERIAL CONSISTENT WITH A METALLOSIS REACTION ON THE NECK OF THE FEMORAL STEM AND WAS REMOVED; POCKET OF ABNORMAL TISSUE AROUND THE HIP AND A GRAYISH MATERIAL WITHIN THE POCKET WAS REMOVED; AREA OF CYSTIC CHANGE OVER THE INFEROMEDIAL ACETABULUM; NO CLINICAL INDICATION OF INFECTIOUS PROCESS AND FINDINGS CONSISTENT WITH A METALLOSIS REACTION. FLUID APPEARED TO BE PROTEINACEOUS THICK FLUID WAS CONSISTENT WITH THE CLINICAL PICTURE OF A METALLOSIS REACTION WITHOUT INFECTION. ADAPTER SLEEVE AND FEMORAL STEM ADDED TO COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL 2178597

    Patients

    Seq Age Sex Outcome Treatment
    1 Other