BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTEON HIP COMPONENTS

    MDR report key: 24998272 · Received April 27, 2026

    Report

    Report Number
    1038671-2026-00496
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    August 9, 2024
    Report Date
    April 27, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 01-030-40-0436 - ALT XLE LNR NTRL G4 36: (B)(6). 01-030-01-0450 - ALT CUP CLSTR G4 SZ 50: (B)(6). 170-36-03 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM: (B)(6). 188-01-03 - WEDGE PLASMA X/O SZ 3: (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

    AS REPORTED, APPROXIMATELY 1 YEAR AND 7 MONTHS POST THE INITIAL TOTAL HIP ARTHROPLASTY, THE PATIENT DISLOCATED, EXPERIENCED PAIN, AND WENT TO THE EMERGENCY ROOM FOR REDUCTION. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216322 ALTEON HIP COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization| R SEE H11