BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CRUCIATE TIBIAL TRAY

    MDR report key: 7480828 · Received May 2, 2018

    Report

    Report Number
    0001825034-2018-03152
    Event Type
    Injury
    Date Received
    May 2, 2018
    Report Date
    June 13, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, BUT THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT 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).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD ILOK FEMORAL COMPONENT, CATALOG #: 183004, LOT #: 028660, VANGUARD TIBIAL BEARING, CATALOG #: EP-183420, LOT #: 426530, ARCOM SERIES A THIN PATELLA, CATALOG #: 184784, LOT #: 902110, VANGUARD DRILL WITH STOP, CATALOG #: 32-486257, LOT #: ZB110201, VANGUARD QUICK RELEASE DRILL, CATALOG #: 32-486265, LOT #: 650390. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03151, 0001825034-2018-03152, 0001825034-2018-03153, 0001825034-2018-03154. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, SWELLING, WARM TO THE TOUCH SKIN, FLUID, LIMITED RANGE OF MOTION, THE FEELING OF LOOSENING, DEVELOPMENT OF DROP FOOT, AND HAS FLEXION CONTRACTURE. THE PATIENT IS ALSO NOTED TO NOT BE ABLE TO BEND THE KNEE VERY FAR AND CANNOT ENTIRELY STRAIGHTEN IT OUT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, SWELLING, WARM TO THE TOUCH SKIN, FLUID, LIMITED RANGE OF MOTION AND THE FEELING OF LOOSENING. THE PATIENT IS ALSO NOTED TO NOT BE ABLE TO BEND THE KNEE VERY FAR AND CANNOT ENTIRELY STRAIGHTEN IT OUT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323114 BIOMET CRUCIATE TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J3012839

    Patients

    Seq Age Sex Outcome Treatment
    1 Other