BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MAX ILK ANA RF PS FML 65LT VII

    MDR report key: 25172549 · Received May 14, 2026

    Report

    Report Number
    0001825034-2026-01288
    Event Type
    Injury
    Date Received
    May 14, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K993159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 11-146554, MAXIM PS TIBIAL BEARING, LOT: 706330. 141314, MAXIM MODULAR FINNED STEM, LOT: 765220. 141213, MAXIM PRIMARY TIBIAL PLATE, 002650. 11-150840, BIOMET ALL POLY PATELLAR BUTTON, LOT: 571730. UNKNOWN, PALACOS CEMENT, UNK LOT. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - FEMUR. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA IN THEIR LEFT KNEE. SUBSEQUENTLY, ABOUT 26 YEARS LATER, THE PATIENT CONTACTED THE MANUFACTURER TO REPORT THAT THEY HAD BEEN EXPERIENCING CONSTANT PAIN, CLICKING, AND INTERMITTENT SWELLING. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED YET REGARDING THESE SYMPTOMS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565998 BIOMET MAX ILK ANA RF PS FML 65LT VII PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 365040

    Patients

    Seq Age Sex Outcome Treatment
    1