BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALT HA CLR STD SZ 2

    MDR report key: 23295050 · Received October 15, 2025

    Report

    Report Number
    1038671-2025-03113
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    MEH
    PMA / PMN Number
    K162732
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 5149704 101-05-30 - 3.2MM DRILL BIT30MM 1PK. 4901211 170-36-03 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM. 3731024 180-65-45 - ALTEON 6.5MM SCREW, 45MM. 5050823 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2. 5013226 132-36-52 NV GXL LINER LIPPED 36MM ID GROUP 2. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED HIP PAIN AND STIFFNESS. THE SURGEON BELIEVED THIS TO BE DUE TO MALPOSITION AND LOOSENING OF THE HIP STEM. AS A RESULT, THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 7 YEARS AND 8 MONTHS AFTER INITIAL IMPLANTATION. DURING THE REVISION IT WAS NOTED THAT THE HIP STEM HAD LOST ALL OF THE HYDROXYAPATITE COATING. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020834 ALT HA CLR STD SZ 2 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization| R