BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION HIP COMPONENTS

    MDR report key: 22895076 · Received August 26, 2025

    Report

    Report Number
    1038671-2025-02834
    Event Type
    Injury
    Date Received
    August 26, 2025
    Report Date
    September 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOWING FIELD THAT WAS ENTERED ERRONEOUSLY IN THE INITIAL REPORT: G3: 8/25/2025.

    Additional Manufacturer Narrative · 0

    D10: 130-36-52 - NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS: 4698937; 164-13-10 - NOVATION ELEMENT RO S/O COL SZ 10: 4790035; 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM: 4849046; 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2: 4864192. 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 TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN. AS A RESULT, THE PATIENT IS SCHEDULED FOR A HIP REVISION APPROXIMATELY 8 YEARS AND 3 MONTHS AFTER INITIAL IMPLANTATION. THE PATIENT HAS BILATERAL HIP REPLACEMENTS, AND IT IS UNCLEAR IF BOTH HIPS OR A SINGLE HIP REPLACEMENT WILL BE REVISED. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609292 NOVATION HIP COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other