BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD

    MDR report key: 24689732 · Received March 25, 2026

    Report

    Report Number
    3010536692-2026-00060
    Event Type
    Injury
    Date Received
    March 25, 2026
    Report Date
    May 7, 2026
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 0

    AD HOC REPORT FROM RIPO ITALY REPORTS THE USAGE OF 2391 CASES OF THE BIPOLAR CUP IMPLANTED IN WITH COCR FEMORAL HEADS IN HEMIARTHROPLASTY. THERE WERE 45 REVISIONS FOR THE FOLLOWING REASONS: SEPTIC LOOSENING: 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136132 COCR HEAD HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. 2601XXX/PPT07034 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention