BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE FEMORAL

    MDR report key: 22202145 · Received June 13, 2025

    Report

    Report Number
    0001822565-2025-01916
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    December 9, 2024
    Report Date
    August 1, 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10, H11. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATIONS ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NONE WERE PROVIDED. INSUFFICIENT INFORMATION PROVIDED TO PERFORM A COMPATIBILITY CHECK. COMPLAINT HISTORY REVIEWS CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATIONS. MEDICAL RECORDS WERE NOT PROVIDED. COMPLAINT IS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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.

    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 KNEE TIBIAL LOT# UNK, UNK KNEE 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.

    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 REPORTED THROUGH A JOURNAL ARTICLE THAT 1 PATIENT IN THE GROUP WAS LOST TO FOLLOW-UP DUE TO REVISION WITHIN 3 MONTHS POSTOP. NO REASON OR FURTHER DISCUSSION WAS PROVIDED, AND THE PATIENT WAS EXCLUDED FROM FINAL REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898905 UNK KNEE FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.