BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM CR TIBIAL BEARING

    MDR report key: 7252920 · Received February 8, 2018

    Report

    Report Number
    0001825034-2018-00766
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    February 20, 2017
    Report Date
    February 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-01982. CONCOMITANT MEDICAL PRODUCTS ¿ VANGUARD LEFT FEMUR CATALOG 183072 LOT 632490; BIOMET FINNED STEM CATALOG 141314 LOT 779640; SERIES A PATELLA CATALOG 184768 LOT 525160; REGENEREX TIBIAL TRAY CATALOG 141275 LOT 104960. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOS AND RADIOGRAPHS. PHOTOS PROVIDED SHOW MEDIAL POSTERIOR REGION FRACTURE OF THE TIBIAL TRAY AND SEVERE WEAR ON THE MEDIAL POSTERIOR REGION OF THE POLY. RADIOGRAPH REVIEW CONFIRMED FRACTURE OF THE TIBIAL PLATE AND LOOSENING REGIONALLY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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 WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LEFT KNEE REVISION PROCEDURE APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO A POSTERIOR MEDIAL FRACTURE OF THE TIBIAL TRAY. THE BEARING WAS ALSO FOUND TO BE WORN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98844 VANGUARD DCM CR TIBIAL BEARING KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. 556750

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R