BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTEON 6.5MM SCREW, 20MM

    MDR report key: 21368604 · Received February 12, 2025

    Report

    Report Number
    1038671-2025-00881
    Event Type
    Injury
    Date Received
    February 12, 2025
    Date of Event
    January 9, 2024
    Report Date
    February 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862272645
    PMA / PMN Number
    K141797
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 3802964 - 130-28-51 - NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS 4193333 - 170-28-03 - BIOLOX DELTA FEMORAL HEAD 28MM OD, +3.5MM 5050846 - 186-01-50 - INTEGRIP CC, CLUSTER 50MM, G1 5332464 - 190-30-06 - ALT HA S CLR STD SZ 6 S002903 - 180-65-15 - ALTEON 6.5MM SCREW, 15MM MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-01379. THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION REPORTED IS PROSTHESIS WEAR AND LOOSENING AND A COMBINATION OF RISK FACTORS: SUCH AS USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL) . HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. 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 APPROXIMATELY 65 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, OSTEOLYTIC BONE LOSS, OSTEOLYTIC CHANGE, AND RECALLED POLYETHYLENE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965750 ALTEON 6.5MM SCREW, 20MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862272645

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Hospitalization| R SEE H11.