BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SROM*STM ST,36+8L NK,18X13X160

    MDR report key: 2895175 · Received January 3, 2013

    Report

    Report Number
    1818910-2013-00638
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    October 27, 2012
    Report Date
    December 18, 2012
    Manufacturer
    DEPUY IRELAND
    Product Code
    JDI
    PMA / PMN Number
    K851422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE FEMORAL STEM/SLEEVE PRODUCT AND LOT CODE COMBINATIONS SINCE RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. IT IS KNOWN 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. REF. (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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS HIGH CO/CR LEVELS AND METALLOSIS. REPORT STATES THAT CUP INCLINATION CONTRIBUTED TO THE HIGHER INCIDENCE OF METAL DEBRIS. (B)(4) 2012 - CLINICAL REPORTS RECEIVED. CLINICAL REPORT STATES THE PATIENT WAS REVISED FOR PAIN AND STIFFNESS. (B)(4) 2012 - PATIENTS OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THAT CORROSION WAS FOUND UPON REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3141 SROM*STM ST,36+8L NK,18X13X160 STEM JDI DEPUY IRELAND 2477612

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR