BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 63MM

    MDR report key: 7765273 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-07211
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    February 11, 2007
    Report Date
    September 24, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: CATALOG # UNKNOWN VANGUARD PATELLA LOT # UNKNOWN; CATALOG # 183622 LOT # UNKNOWN; CATALOG # 183222 LOT # UNKNOWN; CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034 - 2018 - 07210, 0001825034 - 2018 - 07209, 0001825034 - 2018 - 07212. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION HAS IDENTIFIED THIS DEVICE DID NOT CONTRIBUTE TO THIS EVENT. PLEASE VOID THIS SUBMISSION.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY LEFT TOTAL KNEE ARTHROPLASTY. TWO YEARS LATER, PATIENT EXPERIENCED A FALL AND WAS DIAGNOSED WITH PERI-PROSTHETIC FEMUR FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604159 BIOMET CC I-BEAM TRAY 63MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention