BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION HIP COMPONENTS

    MDR report key: 23513209 · Received November 10, 2025

    Report

    Report Number
    1038671-2025-03309
    Event Type
    Injury
    Date Received
    November 10, 2025
    Report Date
    November 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 140-36-53 - NV EHXL NTRL LNR G3 36MM: 5883594 160-01-17 - PF STEM TAPERED PLASMA EXT OFFSET SZ 17: 5209527 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM: 6236023 186-01-58 - INTEGRIP CC, CLUSTER 58MM, G3: 6031444 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 RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED LATERAL SIDE HIP PAIN THAT RADIATED DOWN THE THIGH, IMPAIRED WALKING AND STIFFNESS. AS A RESULT, THE PATIENT WAS GIVEN MEDICATION AND IT BAND STRETCHES AND EXERCISES. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2524660 NOVATION HIP COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SEE H11.