BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE MES SIZING/ROT GDE

    MDR report key: 6113722 · Received November 18, 2016

    Report

    Report Number
    1818910-2016-31781
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    December 7, 2015
    Report Date
    November 14, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). DEPUY SYNTHES HAS BEEN INFORMED THAT THE LOT NUMBER IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT CORRESPONDENCE STATES: PATIENT'S FEMUR FRACTURED IN PRIMARY SURGERY WHEN THE ALIGNMENT TOOL WAS BEING USED. THE SURGEON DID NOT NOTIFY HIM OF THE FRACTURE, SO HE TRIED TO REHAB ON THE BROKEN BONE AND IT CAUSED PAIN WHICH LED TO THEM REVISING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763432 ATTUNE MES SIZING/ROT GDE KNEE FEMORAL COMPONENT HWT DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention