BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD AS TIB BRG 16X71

    MDR report key: 7943802 · Received October 8, 2018

    Report

    Report Number
    0001825034-2018-09154
    Event Type
    Injury
    Date Received
    October 8, 2018
    Date of Event
    September 6, 2018
    Report Date
    October 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR POR FMRL-LT 62.5, P/N 183066, L/N: 928230; BIOMET FINN LOCKING BAR; P/N: UNKNOWN, L/N: UNKNOWN. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 09161; 0001825034 - 2018 - 09163; 0001825034 - 2018 - 09165.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY 2 YEARS POST IMPLANTATION. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN, IMPLANT FRACTURES AND LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785401 E1 VNGD AS TIB BRG 16X71 PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 738220

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R