BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTEON HIP COMPONENTS

    MDR report key: 23312374 · Received October 16, 2025

    Report

    Report Number
    1038671-2025-03128
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    August 24, 2021
    Report Date
    October 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 01-030-01-0758 - ALT CUP CLSTR G7 SZ 58: 6925170. 01-030-42-0740 - ALT XLE LNR EXTCOV G7 40: 6435818. 170-40-03 - BIOLOX DELTA FEMORAL HEAD 40MM 0D, +3.5MM: 6853597. 188-00-07 - WEDGE PLASMA S/O SZ 7: 6911773. 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 LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED PAIN AFTER FALLING OUT OF BED APPROXIMATELY 2 MONTHS AFTER INITIAL IMPLANTATION. RADIOGRAPHS SHOWED NO ABNORMALITIES AND A WELL-FIXED IMPLANT. LEFT HIP BURSITIS WAS OBSERVED. AS A RESULT, THE PATIENT UNDERWENT STEROID INJECTION. THIS EVENT WAS REPORTED TO BE RESOLVED. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252873 ALTEON 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.