BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION HIP COMPONENTS

    MDR report key: 20824735 · Received December 2, 2024

    Report

    Report Number
    1038671-2024-04582
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    January 13, 2013
    Report Date
    November 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. (D10) CONCOMITANT DEVICES: 180-01-52 - NV CROWN CUP CLSTR HOLE 52MM GROUP 2: 2321715 120-65-20 - BONE SCREW 6.5MM DIA X 20MM LONG: 2492119 120-65-25 - BONE SCREW 6.5MM DIA X 25MM LONG: 2549226 130-28-52 - NV GXL LNR, NEUTRAL, 28MM ID, GROUP 2 CUPS: 2258534 142-28-93 - COCR FEM HEAD 28MM -3.5 OFFSET 12/14: 2160585 160-00-16 - PF STEM TAPERED PLASMA SZ 16: 2308873 IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    APPROXIMATELY 5 DAY(S) POST-OPERATIVE OF A RIGHT THA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A HEMATOMA. HEMATOMA WITH INCREASED DRAINAGE. THE PATIENT WAS TREATED WITH KEFLEX AND RIVAROXABAN STOPPED. THE OUTCOME OF THIS EVENT WAS REPORTED AS RESOLVED, AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338264 NOVATION HIP COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization