BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION HIP COMPONENTS

    MDR report key: 24442071 · Received February 25, 2026

    Report

    Report Number
    1038671-2026-00180
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    February 5, 2026
    Report Date
    February 25, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 142-36-00 - COCR FEM HEAD 36MM +0 OFFSET 12/14: 3829195 160-30-12 - PF SPLINE PLASMA W/HA SZ 12: 3802410 180-01-52 - NV CROWN CUP CLSTR HOLE 52MM GROUP 2: 3861908 180-65-25 - ALTEON 6.5MM SCREW, 25MM: 3857829 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 10 YEARS AND 9 MONTHS POST THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED A GRINDING SENSATION IN THEIR HIP AND WAS REVISED DUE TO BEING UNSTABLE AND DISLOCATING POSTERIORLY. AN IMAGE PROVIDED SHOWS WEAR OF THE LINER. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273455 NOVATION HIP COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| R SEE H11