BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD TIBIAL TRAY

    MDR report key: 6851411 · Received September 8, 2017

    Report

    Report Number
    0001825034-2017-06974
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    August 13, 2017
    Report Date
    September 18, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: VNGD PS TIB BRG 10X79/83 MM CATALOG# 183660 LOT# 280950. UNKNOWN VANGUARD FEMORAL, CAT#: UNKNOWN LOT#: UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN VANGUARD BEARING, CAT#: UNKNOWN LOT#: UNKNOWN. UNKNOWN VANGUARD FEMORAL, CAT#: UNKNOWN LOT#: UNKNOWN. (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS NOTED TO HAVE BEEN DISCARDED. 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. PRODUCT HAS BEEN DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING PAIN APPROXIMATELY 7 TO 8 WEEKS POST INITIAL IMPLANTATION. RADIOGRAPHS REVEALED THAT THE LOCKING PIN HAD NOT LOCKED SECURELY AND HAD DISLODGED FROM THE TIBIAL TRAY AND ARTICULAR SURFACE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631361 UNKNOWN VANGUARD TIBIAL TRAY PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R