BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE TIBIAL

    MDR report key: 22373200 · Received July 1, 2025

    Report

    Report Number
    0001822565-2025-02285
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    December 9, 2024
    Report Date
    November 25, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D2, D4, G4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. G2: FINLAND. IRMOLA, T., REITO, A., KANGAS, J. ESKELINEN, A., NIEMELAINEN, M., MATTILA, V. M., MOILANEN (2024) ASSESSMENT OF IMPROVEMENT IN FUNCTIONAL OUTCOMES BETWEEN A NOVEL KNEE REPLACEMENT DESIGN AND CONVENTIONAL DESIGNS IN 240 PATIENTS: A RANDOMIZED CONTROLLED TRIAL. ACTA ORTHOPAEDICA 2025 96, 127¿134 HTTPS://DOI.ORG/10.2340/1745367 D10: ADDITIONAL ASSOCIATED PRODUCTS, UNK FEMORAL LOT# UNK. UNK BEARING LOT# UNK. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2. UPON REASSESSMENT OF THE REPORTED EVENT, IT HAS BEEN DETERMINED A ZIMMER BIOMET DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT SHOULD BE VOIDED. 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 THROUGH A JOURNAL ARTICLE THAT ONE PATIENT IN THE GROUP EXPERIENCED A SUPERFICIAL WOUND COMPLICATION. NO TREATMENT WAS SPECIFIED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED. AS NO ADDITIONAL INFORMATION HAS BEEN RECEIVED, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262006 UNK KNEE TIBIAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11 NARRATIVE.