BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TIBIAL TRAY

    MDR report key: 7770523 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07469
    Event Type
    Injury
    Date Received
    August 9, 2018
    Report Date
    August 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    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). MEDICAL PRODUCT: VANGUARD CR ILOK FEM, CATALOG #: 183026, LOT #: UNKNOWN; VGD CRUC RET TIB BRG, CATALOG #: 183441, LOT #: UNKNOWN; BIOMET ARCOM 3 PEG/POST, CATALOG #: UNKNOWN, LOT #: UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 FILLED FOR THIS EVENT: 0001825034-2018-07367; 0001825034-2018-07468; 0001825034-2018-07470. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED URINARY TRACT INFECTION (UTI) AND DEHYDRATION WHICH REQUIRED FURTHER HOSPITALIZATION ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610006 BIOMET CC I-BEAM TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R