BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNK KNEE FEMORAL

    MDR report key: 22373175 · Received July 1, 2025

    Report

    Report Number
    0001822565-2025-02281
    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. SUGGESTED CODE (ANNEX G)- MECHANICAL (G04) - FEMUR. 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 TIBIAL 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, THE EVENT WAS DETERMINED TO BE NOT REPORTABLE AS THE INFECTION OCCURRED GREATER THAN 90 DAYS POST-OP. 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 TWO PATIENTS IN THE GROUP EXPERIENCED A SUPERFICIAL WOUND INFECTION TREATED WITH ORAL ANTIBIOTICS. 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
    1193908 UNK KNEE FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI

    Patients

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