BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMICAP

    MDR report key: 24874417 · Received April 14, 2026

    Report

    Report Number
    3004154314-2026-00001
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    April 8, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    KWD
    PMA / PMN Number
    K063370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT MADE NO INDICATION OF ANY ARTHROSURFACE DEVICE MALFUNCTION OR DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR DEVICE PERFORMANCE CONTRIBUTING TO THE ADVERSE EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION AND STERILIZATION DOCUMENTATION FOR THE DEVICE IN QUESTION REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 0

    A COMPLAINT WAS INITIATED ON (B)(6) 2026 FOLLOWING NOTIFICATION OF A BONE FRACTURE THAT OCCURED DURING ORIGINAL SURGERY DATED (B)(6) 2026 WHILE IMPLANTING THE TAPER POST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21370 HEMICAP PROSTHESIS, TOE, HEMI-, PHALANGEAL KWD ARTHROSURFACE, INC. 75LD9250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization