BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM STM STD 36+12L 13X18

    MDR report key: 2970300 · Received February 20, 2013

    Report

    Report Number
    1818910-2013-03906
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2013
    Manufacturer
    DEPUY IRELAND
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AGAINST THE PROVIDED (B)(4) LOT CODES FINDS NO OTHER REPORTS OF CORROSION. IT IS KNOWN THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITYT TO DETERMINE ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION HAS NOT BEEN INDICATED.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

    PATIENT WAS REVISED TO ADDRESS SOFT TISSUE DESTRUCTION AND FLUID CAUSING PAIN. **UPDATE** LITIGATION PAPERS RECEIVED (B)(6) 2012 AND ATTACHED. COMPLAINT CHANGED TO LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. **UPDATE**(B)(6) 2013-MAUDE REPORT ((B)(4)) RECEIVED. MAUDE REPORT STATES PATIENT STARTING EXPERIENCING PAIN WHICH CAUSED A LIMP AND HAD A HIP ASPIRATION IN 2010 WHICH SHOWED ELEVATED COBALT IONS INDICATING METAL ON METAL SYNOVITIS DUE TO THE FAILURE OF THIS PRODUCT. THE REVISION FINDINGS ARE FOREIGN BODY SYNOVITIS WITH LARGE EFFUSION, SYNOVIAL AND CAPSULAR TISSUE NECROSIS, CORROSION OF THE FEMORAL NECK-HEAD, AND INCREASING SYMPTOMS INCLUDING SQUEAKING AND GRINDING AND SENSE OF INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72941 SROM STM STD 36+12L 13X18 STEM MRA DEPUY IRELAND 2015120

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention