BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 24678252 · Received March 24, 2026

    Report

    Report Number
    1038671-2026-00314
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    March 4, 2026
    Report Date
    March 23, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207098
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 01-032-03-4000 - UNIV.CUP CABEZA CERAM. DELTA 40 +0 1803.7636.217/002, 164-01-14 - VASTAGO ELEMENT S/COLLAR OFFSET STD. Nº14 (B)(6), 180-11-56 - (DISC) NOVATION CROWN CU P, CLUSTER-HOLE WITH HA, (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 A PATIENT, WHO HAD A THA, REPORTED EARLY WEAR OF PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE AND INDICATED A MAJOR DISABILITY AND NEED FOR SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735052 NOVATION PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862207098

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| S SEE H11