PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

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.

Description of Event or Problem

A LITERATURE REVIEW IDENTIFIED THE ARTICLE, GEDIKBA[?] M, A[?]C[?] M, EREN M, GÜNE[?] T. RADIAL HEAD ARTHROPLASTY PROVIDES SUCCESSFUL LONG-TERM RESULTS IN PATIENTS TREATED FOR COMMINUTED FRACTURES OF THE RADIAL HEAD, MINIMUM EIGHT-YEAR FOLLOW-UP ACTA ORTHOPAEDICA ET TRAUMATOLOGICA TURCICA. 2025 NOV;59(6):439-445. PMCID: PMC12831068. THIS RETROSPECTIVE STUDY ASSESSED LONG-TERM OUTCOMES IN PATIENTS TREATED WITH RADIAL HEAD ARTHROPLASTY FOR COMMINUTED FRACTURES OF THE RADIAL HEAD. A TOTAL OF 35 PATIENTS WERE FOLLOWED FOR PROCEDURES PERFORMED BETWEEN 2011 AND 2018. ALL PATIENTS WERE TREATED WITH THE ACUMED ANATOMIC RADIAL HEAD SYSTEM. THE MEAN AGE FOR THE PATIENTS WAS 47.8 ± 15.6 YEARS (RANGE 29-78 YEARS) WITH A MEAN FOLLOW-UP PERIOD OF 117.3 ± 9.3 MONTHS (RANGE 96-134 MONTHS). THERE WERE 23 MALE AND 12 FEMALE PATIENTS. PATIENTS WERE ASSESSED FOR RADIOLOGICAL OUTCOMES, RANGE OF MOTION, ELBOW FUNCTIONALITY, THE MAYO ELBOW PERFORMANCE SCORE (MEPS), AND THE QUICK DISABILITIES OF THE ARM, SHOULDER, AND HAND SCORE (QDASH). THE FRACTURE PATTERNS FOR THE PATIENTS INCLUDED 10 MASON TYPE IV FRACTURES AND 25 MASON TYPE III FRACTURES. EIGHT (8) PATIENTS HAD A CONCOMITANT TERRIBLE TRIAD INJURY AND ONE (1) PATIENT HAD CHONDRAL DAMAGE TO THE CAPITELLUM. FOR ALL PATIENTS, COMPLICATIONS WERE REPORTED IN NINE (9) PATIENTS. TWO (2) PATIENTS HAD IMPLANT LOOSENING, THREE (3) PATIENTS HAD HETEROTOPIC OSSIFICATION, AND FOUR (4) PATIENTS HAD CAPITELLAR EROSION. PATIENTS HAD A MEAN QDASH SCORE OF 16.7 ± 10.8 AND A MEAN MEPS SCORE OF 87.5 ± 10.3. RANGE OF MOTION OUTCOMES WERE AS FOLLOWS: FLEXION 132.1[?]± 16.1[?], EXTENSION DEFICIT 5.1[?]± 12.0[?], SUPINATION 77.1[?]± 4.6[?], AND PRONATION 75.3[?]± 4.9[?]. FIVE (5) PATIENTS WITH LIMITED RANGE OF MOTION UNDERWENT A SECONDARY SURGERY. FOR THE IMPLANT LOOSENING PATIENTS, ONE HAD A REVISION SURGERY AT 99 MONTHS AND THE OTHER PATIENT AT 102 MONTHS. SURVIVORSHIP OF THE IMPLANT WAS 100% AT 2 YEARS, 97% AT 8 YEARS, AND 94% AT 10 YEARS. THE AUTHORS CONCLUDED THAT USE OF RADIAL HEAD ARTHROPLASTY FOR NONRECONSTRUCTABLE RADIAL HEAD FRACTURES IS A RELIABLE METHOD TO RESTORE ELBOW STABILITY, REDUCE PAIN, AND IMPROVE THE QUALITY OF LIFE FOR PATIENTS.