BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNE-UNK-LPS FLEX TIBIA OPTION SIZE 4

    MDR report key: 16644747 · Received March 30, 2023

    Report

    Report Number
    0001822565-2023-00881
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    March 21, 2023
    Report Date
    June 14, 2023
    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
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.   NO PRODUCT WAS RETURNED OR PICTURES PROVIDED WERE INSUFFICIENT TO PERFORM VISUAL OR DIMENSIONAL EVALUATIONS. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. INSUFFICIENT INFORMATION PROVIDED TO PERFORM A COMPATIBILITY CHECK. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. THE COMPLAINT WAS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE, FOREIGN: UK. THE PRODUCT HAS NOT BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AT THIS TIME. ATTEMPTS TO RETRIEVE THE DEVICE ARE UNDERWAY BUT TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS: KNE-UNK-LPS FLEX FEMORAL SIZE E; KNE-UNK-LPS FLEX INSERT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

     IT WAS REPORTED THE PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A TIBIAL FRACTURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443494 KNE-UNK-LPS FLEX TIBIA OPTION SIZE 4 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R SEE H10 NARRATIVE