BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL TRAY

    MDR report key: 6694604 · Received July 7, 2017

    Report

    Report Number
    0001825034-2017-04615
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    October 16, 2015
    Report Date
    April 6, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [LOCATION UNKNOWN AT THIS TIME] TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT(S): VAN PS OPEN INTL FEM-LT 70 PN183132 LN442030; KNE-UNKNOWN-BEARING-UNK PNUNK LNUNKL REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT WAS REVISED FOR UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475263 UNKNOWN TIBIAL TRAY PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R