BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTEON HIP COMPONENTS

    MDR report key: 19716393 · Received July 10, 2024

    Report

    Report Number
    1038671-2024-02350
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    July 2, 2024
    Report Date
    November 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4940953 132-36-52 - NV GXL LINER LIPPED 36MM ID GROUP 2. 4861124 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM. 4929723 101-05-30 - 3.2MM DRILL BIT30MM 1PK. 4886108 180-65-20 - ALTEON 6.5MM SCREW, 20MM. 4821685 180-65-35 - ALTEON 6.5MM SCREW, 35MM. 4925615 186-01-52 - INTEGRIP CC, CLUSTER 52MM, G2. 4916437 190-20-07 - ALT HA S NOCLR STD SZ 7.

    Description of Event or Problem · 0

    APPROXIMATELY 6 YEARS 10 MONTHS AFTER INITIAL RIGHT THA, THE PATIENT WAS REVISED DUE TO PAIN AND DISSATISFACTION. UPON EXAMINATION, THE PATIENT HAS A RECALLED POLY LINER. THE PATIENT UNDERWENT A POLY ACETABULAR LINER SWAP AND A FEMORAL HEAD SWAP. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS REVISED TO EXACTECH DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS PROVIDED. THE DEVICE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348230 ALTEON HIP COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention