BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 10X71/75

    MDR report key: 11700698 · Received April 21, 2021

    Report

    Report Number
    0001825034-2021-01191
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    May 15, 2017
    Report Date
    April 27, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 183053 - FEMORAL COMPONENT - 813000; 141224 - TIBIAL TRAY - J3252931; 402283 - COBALT BONE CEMENT - 859930. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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: 0001825034-2021-01190, 0001825034-2021-01192.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY RIGHT TKA. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN, LOOSENING AND INSTABILITY APPROXIMATELY 2 YEARS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597900 VNGD CR TIB BRG 10X71/75 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 447810

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R