BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY STEM

    MDR report key: 2882229 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-28471
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    September 19, 2012
    Report Date
    December 3, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. BASED ON THE INABILITY 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

    LITIGATION PAPERS ALLEGE THAT THE PATIENT DEVELOPED PAIN, LOOSENING, AND METALLOSIS AMONG OTHER INJURIES IN HIS HIP AFTER IMPLANTATION WITH THE ASR HIP IMPLANT. (B)(4) 2012 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. REVISION REPORTED. RECORDS INDICATE CORROSION AROUND THE TAPER WAS FOUND UPON REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY STEM STEM JDI DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1