BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTEON

    MDR report key: 24738180 · Received March 31, 2026

    Report

    Report Number
    1038671-2026-00354
    Event Type
    Injury
    Date Received
    March 31, 2026
    Report Date
    March 31, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 01-030-01-0450 - ALT CUP CLSTR G4 SZ 50: (B)(6). 01-030-40-0432 - ALT XLE LNR NTRL G4 32: (B)(6). 170-32-03 - BIOLOX DELTA FEMORAL HEAD 32MM OD, +3.5MM: (B)(6). 190-21-08 - ALT HA S NOCLR EXT SZ 8: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT, WHO HAD A RIGHT THA, UNDERWENT A REVISION PROCEDURE. THE PATIENT WAS DISLOCATING. THE STEM WAS KEPT IN; A NEW HEAD AND SLEEVE WERE REPLACED. THE CUP AND LINER WERE REVISED TO A COMPETITOR¿S DEVICES PER THE SURGEON¿S REQUEST. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THE HOSPITAL WON'T RELEASE THEM. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799054 ALTEON PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11.