BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ILOK PRI TIB TRAY 75MM

    MDR report key: 16469968 · Received March 2, 2023

    Report

    Report Number
    0001825034-2023-00441
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    February 7, 2023
    Report Date
    June 14, 2023
    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
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS NOT RETURNED BY THE FACILITY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS & MDRS 183054 VANGUARD CR POR FEM-RT 75 LOT# 407250. MDR: 0001825034-2023-00440. UNK- 18X 71/75 BEARING LOT# UNK. MDR: 0001825034-2023-00442.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIVING ADDITIONAL INFORMATION FOUND DURING INVESTIGATION OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE PART REFERENCED SHOULD NOT HAVE BEEN REPORTED. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO INSTABILITY. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION FOUND DURING INVESTIGATION OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE PART REFERENCED SHOULD NOT HAVE BEEN REPORTED. THE INITIAL REPORT SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504403 BIOMET ILOK PRI TIB TRAY 75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 420670

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10 NARRATIVE