BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY MENISCAL BEARINGS

    MDR report key: 3182873 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-19534
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    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. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEW AND/OR SEARCHING THE COMPLAINT DATABASE BY LOT CODE WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4). PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. REVIEW OF THE MEDICAL RECORDS CONFIRMED THE REPORTED SUBLUXED DEVICE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE SUBLUXED DEVICE BASED ON THE AVAILABLE INFORMATION. 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 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 WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE. THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION IS UNKNOWN. UPDATE 05/30/2013 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION THE MENISCAL BEARINGS WERE SUBLUXED POSTERIORLY AND THE THERE WAS METALLOSIS STAINING OF THE SYNOVIUM. MENISCAL BEARINGS ARE BEING ADDED TO THE COMPLAINT AND THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283524 UNKNOWN DEPUY MENISCAL BEARINGS MENISCAL BEARINGS JWH 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention