BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD KNEE SYSTEM CR TIBIAL BEARING DCM ARCOM

    MDR report key: 6029534 · Received October 14, 2016

    Report

    Report Number
    0001825034-2016-04120
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    August 15, 2016
    Report Date
    March 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04119 / 04120).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: BIOMET TIBIAL LOCKING BAR CATALOG 141205 LOT 056660; ASCENT RIGHT FEMUR CATALOG 179005 LOT 458230; BIOMET TIBIAL TRAY CATALOG 141237 LOT 403410; BIOMET PATELLA CATALOG 11-150844.

    Description of Event or Problem · 1

    DURING A KNEE REVISION PROCEDURE THE NECESSARY SIZE REPLACEMENT TIBIAL BEARING WAS NOT AVAILABLE; THERE WAS A FOUR HOUR DELAY WHILE THE CORRECT SIZE BEARING WAS LOCATED AND COURIERED FROM ANOTHER HOSPITAL. DURING THIS DELAY THE EXPLANT WAS RE-IMPLANTED IN THE PATIENT AND THE WOUND CLOSED UNTIL THE REPLACEMENT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680636 VANGUARD KNEE SYSTEM CR TIBIAL BEARING DCM ARCOM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 140480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O