BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION HIP COMPONENTS

    MDR report key: 23729361 · Received December 5, 2025

    Report

    Report Number
    1038671-2025-03485
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    September 8, 2025
    Report Date
    December 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    MEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 180-01-52 - CROWN CUP, CLUSTER-HOLE GR.52: SN#: (B)(6). 140-32-52 - NOVATION XLE NEUTRAL LINER, GROUP 2, 32 MM: SN#: (B)(6). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THA (TOTAL HIP ARTHROPLASTY). SUBSEQUENTLY, THE PATIENT EXPERIENCED AN INFECTION RESULTING IN THE REMOVAL OF THE PROTHESIS AND A SPACER IMPLANTED. APPROXIMATELY 1.5 MONTHS LATER, A COMPETITOR'S PROSTHESIS WAS IMPLANTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2167190 NOVATION HIP COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization SEE H11.