BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEM ADAP SLEV 12/14(EJF FZ)

    MDR report key: 5193706 · Received November 1, 2015

    Report

    Report Number
    1818910-2015-34115
    Event Type
    Injury
    Date Received
    November 1, 2015
    Date of Event
    October 26, 2015
    Report Date
    October 27, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: UNAVAILABLE. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT SUFFERS FROM PAIN, SWELLING, INFLAMMATION, INFECTION, AND DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. METALLOSIS WAS NOTED UPON REVISION.

    Description of Event or Problem · 1

    UPDATE JUN 22, 2017: LEGAL MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED DUE TO EXTENSIVE METALLOSIS, SYNOVITIS, AND SOFT TISSUE PSEUDOTUMOR. REVISION NOTES STATED THAT THERE WAS A YELLOW MUSTARD PURULENCE CONSISTENT WITH METALLOSIS, AND EXTENSIVE SYNOVITIS. THERE WAS SMALL POCKET ALONG THE INFERIOR MEDIAL ASPECT, WHICH HAS SOME OSTEOLYSIS. ARTICULATING COMPONENTS WERE NOTED TO BE CLEAN AND FREE OF CORROSION. LABORATORY RESULTS FOR COBALT- CHROMIUM WERE ABOVE 7PPB. PRODUCT CODES AND LOT NUMBERS WERE PROVIDED. THIS COMPLAINT WAS UPDATED ON JUN 28, 2017

    Description of Event or Problem · 1

    UPDATE AUG 1, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, CLINICAL NOTES REPORTED OF GRINDING OR POPPING SENSATION AND DISCOMFORT. THIS COMPLAINT WAS UPDATED ON AUG 16, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724046 ASR UNI FEM ADAP SLEV 12/14(EJF FZ) HIP FEMORAL STEM/SLEEVE KWA DEPUY INTERNATIONAL LTD. 8010379 2346030

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other