BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 11

    MDR report key: 24464409 · Received February 26, 2026

    Report

    Report Number
    1038671-2026-00202
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    March 18, 2021
    Report Date
    May 20, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    MEH
    UDI-DI
    10885862035097
    PMA / PMN Number
    K080980
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 01-034-05-5044, UNIVERSAL CUP, PRESSFIT, 3 COVERS, HA, 50MM - 44. 01-033-03-4436, UNIVERSAL CUP LINER, DELTA, 44MM - 36. 01-032-03-3694, UNIVERSAL CUP, HEAD, DELTA, 36MM, -4. 01-034-05-4639, UNIVERSAL CUP, PRESSFIT, 3 COVERS, HA, 46MM - 39. 01-033-03-3932, UNIVERSAL CUP LINER, DELTA, 39MM - 32. 01-032-03-3294, UNIVERSAL CUP, HEAD, DELTA, 32MM, -4. 01-032-03-3200, UNIVERSAL CUP, HEAD, DELTA, 32MM, +0. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 42 YO PATIENT, WHO HAD THA¿S ON BOTH HIPS ON DIFFERENT DATES, UNDERWENT A REVISION PROCEDURE ON THE LEFT HIP APPROXIMATELY 1 YEAR 9 MONTHS POST THE INITIAL PROCEDURE. THE REPORTED INFORMATION INDICATED THERE WAS NOTIFICATION OF WEAR AND TEAR AND COMPREHENSIVE FOLLOW-UP FOR PATIENTS TREATED SURGICALLY AND EXPERIENCING PROBLEMS WITH THE IMPLANTED MATERIALS. HOSPITALIZATION REQUIRED, NEED FOR INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY, PHYSICAL, EMOTIONAL, SOCIAL, AND WORK-RELATED IMPACT WAS ALSO REPORTED. THE REPORT STATED THE ACETABULAR COMPONENT IN BOTH HIPS REMAINS IMPLANTED. NO DEVICE IMAGES OR X-RAYS WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154686 ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 11 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH EXACTECH, INC. 10885862035097

    Patients

    Seq Age Sex Outcome Treatment
    1