BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET ARCOM 3 PEG PATELLA 31MM

    MDR report key: 8041966 · Received November 6, 2018

    Report

    Report Number
    0001825034-2018-10241
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    March 29, 2009
    Report Date
    November 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CRUCIATE RETAINING INTERLOK FEMORAL COMPONENT RIGHT 62.5MM, CATALOG #: 183006, LOT #: NI. VANGUARD CRUCIATE RETAINING LIPPED TIBIAL BEARING 14MM X 63MM/67MM, CATALOG #: 183524, LOT #: NI. BIOMET CC I-BEAM TIBIAL TRAY 67MM, CATALOG #: 141222, LOT #: NI. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE COMPLAINT SAMPLE WAS NOT EVALUATED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 1825034-2018-10238, 1825034-2018-10239, 1825034-2018-10240.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT EXPERIENCED A FALL APPROXIMATELY TEN (10) MONTHS FOLLOWING RIGHT KNEE ARTHROPLASTY THAT RESULTED IN A LEFT DISTAL FIBULA FRACTURE. IT IS UNKNOWN AT THIS TIME WHETHER THE IMPLANTS CONTRIBUTED TO THE PATIENT¿S FALL. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883773 UNKNOWN BIOMET ARCOM 3 PEG PATELLA 31MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other