BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET FINNED PRI STEM 40MM

    MDR report key: 7943886 · Received October 8, 2018

    Report

    Report Number
    0001825034-2018-09165
    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
    PK915132
    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. 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 - 09154, 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 AND IMPLANT COMPONENT FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783368 BIOMET FINNED PRI STEM 40MM PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 409000

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization