BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2122740 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-09754
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    March 9, 2011
    Report Date
    May 5, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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

    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

    UPDATE (B)(4) 2011 - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES ELEVATED METAL ION LEVELS AND A LARGE AMOUNT OF TAN MATERIAL THAT WAS SOMEWHAT GRANULAR RATHER THAN FIBROTIC. ADDITIONALLY, THERE WAS A GREAT DEAL OF GRAYISH SOFT TISSUE IN THE ACETABULUM AND INSIDE THE SYNOVIUM. THE FEMORAL HEAD WAS ADDED TO THE COMPLAINT. 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. (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 SUFFERED AND CONTINUES TO SUFFER SYMPTOMS INCLUDING, BUT NOT LIMITED TO SEVERE PAIN, WEAKNESS, DECREASED RANGE OF MOTION, SENSATION OF "CATCHING" AND MISALIGNMENT, AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING SUCH AS WALKING AND STANDING AFTER BEING SEATED. UPDATE: (B)(6) 2011 - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES ELEVATED METAL ION LEVELS AND A LARGE AMOUNT OF TAN MATERIAL THAT WAS SOMEWHAT GRANULAR RATHER THAN FIBROTIC. ADDITIONALLY, THERE WAS A GREAT DEAL OF GRAYISH SOFT TISSUE IN THE ACETABULUM AND INSIDE THE SYNOVIUM. THE FEMORAL HEAD WAS ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2760712

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention