BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET FIXED I-BEAM STEM TIBIAL TRAY

    MDR report key: 7767585 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07612
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    February 24, 2006
    Report Date
    September 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-07610, 0001825034-2018-07611, 0001825034-2018-07612, AND 0001825034-2018-07613. MEDICAL DEVICES: VANGUARD CR ILOK FEM-RT 65, CATALOG#: 183008; VNGD CR LIP TIB BRG 14X71/75MM, CATALOG#: 183544; BIOMET ARCOM 3 PEG/POST SIZE 3. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS NOTED TO HAVE NAUSEA AND FATIGUE REQUIRING VISIT TO ER FROM OFFICE VISIT TO RULE OUT PULMONARY EMBOLISM. NO EMBOLISM OR REVISION PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608123 BIOMET FIXED I-BEAM STEM TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other