BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL COMPONENT

    MDR report key: 18777078 · Received February 26, 2024

    Report

    Report Number
    0001825034-2024-00500
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    February 2, 2024
    Report Date
    June 4, 2024
    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
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D10: 152836 - AGC ANATOMIC INTLK FMRL 70 RT 0 - 477760. VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND THAT THE TIBIAL PLATE, FEMORAL AND ART SURFACE WERE REMOVED. FEMORAL AND TIBIAL PLATE SHOW BONE CEMENT ATTACHED. THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THERE IS NO EVIDENCE OF LOOSENING OR ABNORMAL RADIOLUCENCY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 : UNKNOWN: UNKNOWN ARTICULAR SURFACE - UNKNOWN. UNKNOWN: UNKNOWN FEMORAL COMPONENT - 477760. G2 : FOREIGN COUNTRY: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2024-00498, 0001825034-2024-00499.

    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 FURTHER REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY. APPROXIMATELY 16 YEARS LATER, THEY WERE REVISED DUE TO LOOSENING AND OSTEOLYSIS. BOTH THE FEMORAL AND TIBIAL COMPONENTS WERE LOOSE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336591 UNKNOWN TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R