PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Additional Manufacturer Narrative

MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS MODEL NUMBER AND BATCH/LOT NUMBER ARE UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

(REPORT 13 OF 28) IN THE ARTICLE "ANATOMIC MONOPOLAR PRESS-FIT RADIAL HEAD ARTHROPLASTY; HIGH RATE OF LOOSENING AT MID-TERM FOLLOW UP" BY SAMRA, I., ET AL, THE AUTHORS STATED RADIAL HEAD ARTHROPLASTY (RHA) IS USED FOR THE MANAGEMENT OF UNSTABLE OR UNRECONSTRUCTABLE INJURIES OF THE RADIAL HEAD. THE AUTHOR'S AIM WAS TO INVESTIGATE CLINICAL AND RADIOGRAPHIC OUTCOMES IN PATIENTS TREATED WITH THE ACUMED ANATOMIC RADIAL HEAD PRESS-FIT SYSTEM FOR TRAUMA. ALL PATIENTS WERE OPERATED ON BETWEEN JANUARY 2009-JULY 2015 USING THE ACUMED ANATOMIC RADIAL HEAD SYSTEM (ACUMED, HILLSBORO, OR, USA). 16 CONSECUTIVE ACUTE TRAUMA CASES TREATED WITH THE ACUMED ANATOMIC RADIAL HEAD SYSTEM BETWEEN 2009-2015 WERE INCLUDED. THERE WERE IN 11 FEMALES AND 5 MALES WITH A MEAN AGE OF 53 YEARS ±13 (RANGE 21-82), WITH 8/16 CASES INVOLVING THE DOMINANT ARM. THE FOLLOWING COMPLICATIONS WERE REPORTED: ONE REMOVAL OF LOOSENED DEVICE FOR PAINFUL CAPITELLAR EROSION AND PAIN, ONE REMOVAL OF LOOSENED DEVICE FOR CAPITELLAR EROSION AND ULNOHUMERAL ARTHRITIS REQUIRING REVISION TO TOTAL ELBOW ARTHROPLASTY, ONE REMOVAL OF WELL-FIXED DEVICE TO ADDRESS STIFFNESS FROM HETEROTROPHIC OSSIFICATION, ONE LOOSE STEM NOT REMOVED, 13 SUBCOLLAR OSTEOLYSIS, 5 INSTANCES OF HETEROTOPIC OSSIFICATION ONE CAPITELLAR EROSION WITH STEM NOT REMOVED, 5 INSTANCES OF OSTEOARTHRITIC CHANGES THERE ARE 28 RELATED REPORT NUMBERS FOR THIS EVENT 3025141-2024-00344 THROUGH 3025141-2024-00371.