BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REV FEM/TIB/SLEEVE CLAMP

    MDR report key: 7129058 · Received December 19, 2017

    Report

    Report Number
    1818910-2017-52073
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 27, 2017
    Report Date
    November 27, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HXD
    UDI-DI
    10603295096238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. 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). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMORAL TIBIAL SLEEVE CLAMP WOULDN'T STAY CLOSED TO TIGHTEN STEM WITH 2 DIFFERENT ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909242 REV FEM/TIB/SLEEVE CLAMP KNEE INSTRUMENT : CLAMPS HXD DEPUY ORTHOPAEDICS INC US 10603295096238

    Patients

    Seq Age Sex Outcome Treatment
    1