ANATOMIC RADIAL HEAD SYSTEM

Description of Event or Problem

A LITERATURE REVIEW IDENTIFIED THE ARTICLE, TARALLO L, CELLI A, BENEDETTI L, ET AL. LONG-TERM SURVIVAL OF ACUMED ANATOMICAL RADIAL HEAD IMPLANT FOR MASON TYPE III-IV FRACTURES: A 15-YEAR FOLLOW-UP. JOURNAL OF SHOULDER AND ELBOW SURGERY. 2025 JUL:S1058-2746(25)00514-2. DOI: 10.1016/J.JSE.2025.05.038. PMID: 40675541. THIS RETROSPECTIVE ITALIAN STUDY FOLLOWED 149 PATIENTS TREATED FOR MASON TYPE III AND IV RADIAL HEAD FRACTURES USING THE ACUMED ANATOMIC RADIAL HEAD (ARH) IMPLANT. THE STUDY EVALUATED CLINICAL OUTCOMES USING THE MAYO ELBOW PERFORMANCE SCORE (MEPS), IMPLANT SURVIVAL OVER 15 YEARS, AND COMPLICATIONS. THE ACUMED ARH IMPLANTS HAD A MEAN FOLLOW-UP TIME OF 7 YEARS (RANGE 1-15 YEARS). A KAPLAN-MEIER ANALYSIS SHOWED THAT MOST IMPLANT REMOVALS OCCURRED WITHIN THE FIRST 24 MONTHS. SEVEN (7) PATIENTS UNDERWENT IMPLANT REMOVAL AT AN AVERAGE OF 19 MONTHS, YIELDING AN IMPLANT SURVIVAL RATE OF 95%. COMPLICATIONS REPORTED INCLUDED JOINT STIFFNESS IN 14 PATIENTS LEADING TO IMPLANT REMOVAL IN 3 PATIENTS DUE TO OVERSTUFFING OF THE IMPLANT. IMPLANT LOOSENING OCCURRED IN 7 PATIENTS, LEADING TO REMOVAL OF THE IMPLANT IN 4 PATIENTS WHERE OVERSTUFFING WAS CONFIRMED IN 2 PATIENTS. HETEROTOPIC OSSIFICATION WAS DETECTED IN 72 PATIENTS ACCORDING TO THE HASTINGS AND GRAHAM'S CRITERIA. ONE (1) PATIENT WAS CLASSIFIED AS GRADE III AND 12 PATIENTS HAD A GRADE IIC. NONE OF THE PATIENTS REQUIRED A REOPERATION DUE TO PATIENT OVERALL SATISFACTION WITH MOVEMENT AND FUNCTIONALITY MEPS SCORES. THE AUTHORS CONCLUDED THAT THE ACUMED ARH IMPLANTS OFFER A RELIABLE AND EFFECTIVE TREATMENT OF COMPLEX RADIAL HEAD FRACTURES DUE TO ITS DATA FOR IMPLANT SURVIVAL, LOW REVISION RATE, AND HIGH PATIENT SATISFACTION.

Additional Manufacturer Narrative

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 (47 TOTAL FOR THIS ARTICLE): NOTE, THIS MDR IS INCLUDED IN THE LIST BELOW. 3025141-2025-00389, 3025141-2025-00390, 3025141-2025-00391, 3025141-2025-00392, 3025141-2025-00393, 3025141-2025-00394, 3025141-2025-00395, 3025141-2025-00396, 3025141-2025-00398, 3025141-2025-00399, 3025141-2025-00400, 3025141-2025-00401, 3025141-2025-00402, 3025141-2025-00403, 3025141-2025-00404, 3025141-2025-00405, 3025141-2025-00406, 3025141-2025-00407, 3025141-2025-00408, 3025141-2025-00409, 3025141-2025-00410, 3025141-2025-00411, 3025141-2025-00412, 3025141-2025-00413, 3025141-2025-00414, 3025141-2025-00415, 3025141-2025-00416, 3025141-2025-00417, 3025141-2025-00418, 3025141-2025-00419, 3025141-2025-00420, 3025141-2025-00421, 3025141-2025-00422.