BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 71MM

    MDR report key: 7769451 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07400
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    April 10, 2007
    Report Date
    September 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-07397, 0001825034-2018-07399, 0001825034-2018-07400, AND 0001825034-2018-07402. CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR ILOK FEM-RT 65, CATALOG#: 183008, LOT#: NI. VNGD CR TIB BRG 14X71/75, CATALOG#: 183444, LOT#: NI. UNKNOWN PATELLA CATALOG#: NI, LOT#: NI. 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.

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW, IT WAS DETERMINED THIS PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT EXPERIENCED A FALL DUE TO KNEE GIVING WAY. NO REVISION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611488 BIOMET CC I-BEAM TRAY 71MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other