UNK - RADIAL HEAD PROSTHESIS

Description of Event or Problem

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GOLDSTEIN AR, PADON B, FONG C, HAMMOND B, GANTA A, KONDA S, EGOL KA, TEJWANI N. CONTEMPORARY ANALYSIS OF REVISION AND RESECTION RATES IN RADIAL HEAD ARTHROPLASTY USED IN ELBOW TRAUMA. J ORTHOP TRAUMA. 2026 MAR 1;40(3):155-159. DOI: 10.1097/BOT.0000000000003120. PMID: 41182895. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY AIMED TO CONDUCT A COMPREHENSIVE MODERN (2012¿2024) ANALYSIS OF RESECTION RATES, COMPLICATIONS, AND FUNCTIONAL OUTCOMES AFTER RHA IN AN ELBOW TRAUMA PATIENT POPULATION AT A SINGLE URBAN ACADEMIC INSTITUTION. TWO HUNDRED FIFTY PATIENTS WERE INCLUDED (MEAN AGE 52.2 6 17.8 YEARS, RANGE 18.1¿88.3 YEARS; MEAN LENGTH OF FOLLOW-UP 43.8 6 35.2 MONTHS, RANGE 12.0¿128.0 MONTHS, BODY MASS INDEX 28.7 6 6.3 KG/M 2, 56.8% FEMALE). THIS IS A RETROSPECTIVE COHORT STUDY WAS CONDUCTED AT A MULTISITE URBAN ACADEMIC INSTITUTION TO EVALUATE OUTCOMES AFTER RHA FOR COMPLEX RADIAL HEAD FRACTURES (ORTHOPAEDIC TRAUMA ASSOCIATION (OTA) 2R1) TREATED BETWEEN 2013 AND 2024. 7 ELIGIBLE PATIENTS INCLUDED ADULTS ($18 YEARS OLD) WHO UNDERWENT PRIMARY RHA USING A PRESS-FIT MODULAR IMPLANT FOR COMMINUTED RADIAL HEAD FRACTURES DEEMED NON RECONSTRUCTABLE; RADIAL HEAD FRACTURES ASSOCIATED WITH TERRIBLE TRIAD INJURIES (ELBOW DISLOCATION WITH RADIAL HEAD AND CORONOID FRACTURES); MONTEGGIA FRACTURE VARIANTS INVOLVING THE PROXIMAL ULNA AND RADIAL HEAD; OR AS PART OF A SALVAGE PROCEDURE FOR SYMPTOMATIC MALUNION OR NONUNION OF PRIOR RADIAL HEAD FRACTURES. THE MOST COMMONLY USED IMPLANT SYSTEMS WERE THE EVOLVE RADIAL HEAD (WRIGHT MEDICAL TECHNOLOGY INC; 40.0%, 100/250) AND THE ANATOMIC RADIAL HEAD SYSTEM (ACUMED; 37.2%, 93/250), BOTH OF WHICH WERE EMPLOYED CONSISTENTLY THROUGHOUT THE STUDY DURATION. THE DEPUY SYNTHES RADIAL HEAD SYSTEM WAS USED IN 27 CASES (10.8%), ALL OCCURRING BETWEEN 2013 AND 2016. THE JOHNSON & JOHNSON RADIAL HEAD SYSTEM WAS INTRODUCED IN 2022 AND USED IN 27 CASES (10.8%) THROUGH 2024. OTHER IMPLANT MANUFACTURERS WERE USED INFREQUENTLY, INCLUDING STRYKER (N = 2, 0.8%) AND SKELETAL DYNAMICS (N = 1, 0.4%). AT A MINIMUM OF 1-YEAR FOLLOW-UP FROM INDEX SURGERY, PATIENTS DEMONSTRATED A MEAN ELBOW FLEXION OF 125.4 6 19.7 DEGREES, EXTENSION OF 14.9 6 17.5 DEGREES, PRONATION OF 73.5 6 22.1 DEGREE, AND SUPINATION OF 79.3 6 17.4 DEGREES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNK - RADIAL HEAD PROSTHESIS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - RADIAL HEAD PROSTHESIS (QTY =1): IMPLANT RESECTION (N=1).

Additional Manufacturer Narrative

PRODUCT COMPLAINT#: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.