BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY STEM

    MDR report key: 2982975 · Received February 28, 2013

    Report

    Report Number
    1818910-2013-01454
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    December 5, 2013
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    PATIENT RESIDED IN (B)(6). 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS 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 COMBINATION WAS NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR 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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - MEDICAL RECORDS WERE OBTAINED FOR THE RIGHT HIP. DOI PROVIDED FOR RIGHT HIP. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO A FEMORAL NECK FRACTURE, CYSTS, AND AN INFLAMED SYNOVIUM. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2013.

    Description of Event or Problem · 1

    LEGAL CLAIM RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND METAL DEBRIS. IT IS ADDITIONALLY ALLEGED THAT THE PATIENT SUFFERS FROM CATASTROPHIC HIP FAILURE AND A FEMORAL FRACTURE ON THE RIGHT SIDE.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013-LITIGATION PAPERS RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM RESTRICTED MOBILITY, INFLAMMATION, AND METAL TOXICITY. ALSO ALLEGED ADVERSE LOCAL TISSUE REACTION, ELEVATED SERUM ION LEVELS, AND ELEVATED LEVELS OF CHROMIUM AND COBALT. THE DOR FOR BOTH HIPS WERE PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88246 UNKNOWN DEPUY STEM STEM KWY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention