BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POROUS FINN STEM

    MDR report key: 8389443 · Received March 5, 2019

    Report

    Report Number
    0001825034-2019-00799
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    July 19, 2018
    Report Date
    March 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: ASCENT CLSD BOX PS FMRL; P/N: 178044, L/N: 909580; POROUS FINN STEM; P/N: CP111992, L/N: 821130. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04744 - 1. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION PROCEDURE 15 YEARS POST IMPLANTATION DUE TO FEMORAL DISASSOCIATION FOR STEM JUNCTION FAILURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183532 POROUS FINN STEM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 821130

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R