inforMED
InjuryKWI

ALIGN

Received Feb 13, 2025 · Event occurred Feb 4, 2025

Report 21376302 · MDR key 21376302

Device

Generic name

Prosthesis, Elbow, Hemi-, Radial, Polymer

Catalog number

ALN-RHI-240

Lot number

AN1907030

Patient

51 YR · Male

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

ON (RETRACTED DATE), SURGERY WAS PERFORMED TO REPLACE A LOOSE RIGHT RADIAL HEAD IMPLANT. DURING THE SURGERY, THERE WAS SEVERE METALLOSIS (A CONDITION WHERE METAL PARTICLES FROM MEDICAL IMPLANTS, SUCH AS ARTIFICIAL JOINTS, ACCUMULATE IN THE SURROUNDING TISSUES) OF THE RADIOCAPITELLAR JOINT. THE CAPITELLUM HAD PARTIAL-THICKNESS CARTILAGE WEAR. THE RADIAL HEAD WAS LOOSE. THE SCREW HAD BACKED OUT PARTIALLY. THE RADIAL HEAD WAS REMOVED, LEAVING THE STEM AS THIS WAS WELL-FIXED. THE HEAD NECK JUNCTION WAS PARTIALLY WORN. THE ELBOW WAS THOROUGHLY IRRIGATED OF METAL DEBRIS. A NEW RADIAL HEAD WAS ATTACHED. ON (RETRACTED DATE), THE ORIGINAL SURGERY WAS PERFORMED FOR A RIGHT RADIAL HEAD ARTHROPLASTY. A SKELETAL DYNAMICS DISTAL ELBOW SET WAS IMPLANTED. INTRAOPERATIVE FLUOROSCOPY CONFIRMED POSITIONING, AND THE RADIAL HEAD WAS STABLE THROUGH RANGE OF MOTION.