BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 24682412 · Received March 24, 2026

    Report

    Report Number
    1038671-2026-00332
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 24, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    MEH
    UDI-DI
    10885862207029
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 164-02-09 - ELEMENT-STEM, COLLARLESS W/HA, HIGH OFFSET, SZ 9: (B)(6), 186-01-50 -INTEGRIP CC, CLUSTER 50MM, G1: (B)(6), 01-032-03-3200 - UNIVERSAL CUP, HEAD, DELTA, 32MM, +0: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT, WHO HAD A LEFT THA, REPORTED EARLY WEAR OF PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE AND WAS ADMITTED TO THE HOSPITAL AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742942 NOVATION PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH EXACTECH, INC. 10885862207029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.