BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PRODIGY STEM

    MDR report key: 3933846 · Received July 15, 2014

    Report

    Report Number
    1818910-2014-23363
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    April 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT CONTACTED DEPUY INDICATING THEY WERE REVISED TO ADDRESS A FRACTURED FEMORAL STEM AND PAIN. THE PATIENT'S MEDICAL RECORDS WERE RECEIVED INDICATING THE PATIENT HAD A DEPUY PRODIGY STEM. DOI: (B)(6) 2006 DOR: (B)(6) 2014. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE, IT IS UNLIKELY THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED DEPUY INDICATING THEY WERE REVISED TO ADDRESS A FRACTURED FEMORAL STEM AND PAIN. THE PATIENT'S MEDICAL RECORDS WERE RECEIVED INDICATING THE PATIENT HAD A DEPUY PRODIGY STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411790 UNKNOWN DEPUY PRODIGY STEM HIP FEMORAL STEM/SLEEVE KWY DEPUY ORTHOPAEDICS, INC. 1818910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention