BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENT CLSD BOX PS FMRL LG R

    MDR report key: 7801041 · Received August 21, 2018

    Report

    Report Number
    0001825034-2018-04744
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    July 19, 2018
    Report Date
    March 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K993111
    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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. MEDICAL PRODUCTS: ASCENT CLSD BOX PS FMRL; P/N: 178044, L/N: 909580. POROUS FINN STEM; P/N: CP111992, L/N: 821130. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 00799.

    Description of Event or Problem · 0

    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.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT IS SCHEDULED TO UNDERGO A REVISION ON AN UNKNOWN DATE DUE TO WEAR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644632 ASCENT CLSD BOX PS FMRL LG R PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 909580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R