BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ARCOM PATELLA

    MDR report key: 7444777 · Received April 19, 2018

    Report

    Report Number
    0001825034-2018-02899
    Event Type
    Injury
    Date Received
    April 19, 2018
    Report Date
    January 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, 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 WITH THE INFORMATION 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD TIBIAL CRUCIATE WING, CATALOG #: 185650, LOT #: 920090, VANGUARD 360 TIBIAL TRAY, CATALOG #: 185204, LOT #: 794810, VANGUARD POSTERIOR STABILIZED TIBIAL BEARING, CATALOG #: 183752, LOT #: 340770, BIOMET SMOOTH KNEE STEM, CATALOG #: 145046, LOT #: 810220, VANGUARD POSTERIOR STABILIZED FEMORAL, CATALOG #: 184530, LOT #: 905040. 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: 0001825034-2018-02894, 0001825034-2018-02895, 0001825034-2018-02896, 0001825034-2018-02897, 0001825034-2018-02898, 0001825034-2018-02899. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, SWELLING AND BLEEDING IN THE KNEE. RECENTLY, THE SURGEON REMOVED 60 - 80 CUBIC CENTIMETERS OF BLOOD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287355 BIOMET ARCOM PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 826210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R