BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC RADIAL HEAD SYSTEM

    MDR report key: 22857487 · Received August 21, 2025

    Report

    Report Number
    3025141-2025-00429
    Event Type
    Injury
    Date Received
    August 21, 2025
    Report Date
    August 20, 2025
    Manufacturer
    ACUMED, LLC
    Product Code
    KWI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE INFORMATION IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED. BELOW ARE ALL RELATED REPORT NUMBERS REGARDING THIS LITERATURE REVIEW (10 TOTAL FOR THIS ARTICLE): NOTE, THIS MDR IS INCLUDED IN THE LIST BELOW. 3025141-2025-00423, 3025141-2025-00424, 3025141-2025-00425, 3025141-2025-00426, 3025141-2025-00427, 3025141-2025-00428, 3025141-2025-00430, 3025141-2025-00431, AND 3025141-2025-00432.

    Description of Event or Problem · 0

    A LITERATURE REVIEW IDENTIFIED THE ARTICLE, EYRE-BROOK AI, KANKANALU P, MAJKOWSKI L, ET AL. OUTCOMES OF PRESS-FIT RADIAL HEAD ARTHROPLASTY IN UNCONSTRUCTABLE RADIAL HEAD FRACTURES WITH ASSOCIATED ELBOW INJURIES: AN AVERAGE 5-YEAR FOLLOW UP. SHOULDER & ELBOW. 2025 JUL;17(3):325-331. DOI: 10.1177/17585732241268904. PMID: 39552667; PMCID: PMC11562448. IN A RETROSPECTIVE STUDY, DATA WAS PRESENTED FOR 96 PATIENTS WHO HAD RADIAL HEAD ARTHROPLASTY BETWEEN 2008 TO 2020. PATIENTS WERE TREATED WITH THE ACUMED ANATOMIC RADIAL HEAD (ARH) PRESS-FIT IMPLANTS AND HAD A MINIMUM FOLLOW-UP OF 12 MONTHS. PATIENT OUTCOMES WERE ASSESSED FOR IMPLANT SURVIVAL, RADIOGRAPHIC FINDINGS, AND FUNCTIONAL OUTCOMES USING THE OXFORD ELBOW SCORE (OES) AND MAYO ELBOW PERFORMANCE SCORE (MEPS). OF THE 96 PATIENTS TREATED, 7 PATIENTS HAD THE ARH IMPLANT REMOVED FOR PAIN (N=1), ELBOW INSTABILITY (N=2), STIFFNESS (N=1), OR PAIN AND STIFFNESS (N=3). FOR THE 7 IMPLANTS REMOVED, 6 IMPLANTS WERE LOOSE, BUT ONE PATIENT WITH ELBOW INSTABILITY HAD A WELL-FIXED IMPLANT. REMOVAL OCCURRED AT A MEDIAN TIME OF 17.0 MONTHS (IQR 6.3-21.8). USING A KAPLAN-MEIER SURVIVAL ANALYSIS, A 10-YEAR SURVIVAL ESTIMATE OF 92.1% (95% CONFIDENCE INTERVAL OF 84.0-96.1). OTHER REPORTED COMPLICATIONS INCLUDED ULNAR NERVE COMPRESSION IN 1 PATIENT THAT UNDERWENT ULNA NERVE DECOMPRESSION. TWO (2) PATIENTS HAD A DISTAL HUMERUS FRACTURE THAT REQUIRED FIXATION. PATIENTS HAD A MEDIAN OES OF 43 (IQR 29-46) AND A MEDIAN MEPS OF 90 (IQR 72-100). THESE CLINICAL OUTCOMES SUPPORT THE HIGH IMPLANT SURVIVAL RATES. THE AUTHORS CONCLUDED THAT USE OF A PRESS-FIT IMPLANT FOR RADIAL HEAD ARTHROPLASTY HAD GOOD IMPLANT SURVIVAL AND FUNCTIONAL OUTCOMES FOR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419222 ANATOMIC RADIAL HEAD SYSTEM PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER KWI ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other