BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMET REGENX PRI TIB TRAY 79MM

    MDR report key: 8455271 · Received March 27, 2019

    Report

    Report Number
    0001825034-2019-01446
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    August 30, 2019
    Report Date
    September 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K080361
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04141. CONCOMITANT MEDICAL PRODUCTS: BIOMET FINNED PRI STEM 40MM ITEM# 141314 LOT# 362180, SERIES A PAT STD 37 3 PEG ITEM# 184768 LOT# 359540, VANGUARD CR POR FMRL-LT 75 ITEM# 183074 LOT# 556910, E1 VNGD AS TIB BRG 10X79 ITEM# EP-189100 LOT# 708490. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION FROM THE CUSTOMER. NO DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO LOOSENING OF THE TIBIAL IMPLANT. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT KNEE ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION ON UNKNOWN DATE DUE TO UNKNOWN REASONS. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248463 BMET REGENX PRI TIB TRAY 79MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 158670

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R