BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-STEM AMT SZ2 HIGH OFFSET

    MDR report key: 2870185 · Received December 12, 2012

    Report

    Report Number
    1818910-2012-29163
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    July 29, 2012
    Report Date
    November 13, 2012
    Manufacturer
    DEPUY SUZHOU
    Product Code
    JDI
    PMA / PMN Number
    K042959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE PATIENT'S PREVIOUSLY EXTENSIVE REVISION SURGERY CAUSED TRAUMA TO THE FEMUR THAT HAD NOT YET REPAIRED AND WAS THE LIKELY CAUSE OF THIS COMPLAINT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO A FEMORAL SHAFT FRACTURE. RECORDS ALSO INDICATE THE PATIENT HAD A HEMATOMA AROUND THE FRACTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-STEM AMT SZ2 HIGH OFFSET STEM JDI DEPUY SUZHOU D12022138

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention