ALIGN
Received Feb 13, 2025 · Event occurred Feb 4, 2025
Report 21376302 · MDR key 21376302
Device
Generic name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Manufacturer
Skeletal Dynamics, IncModel number
ALIGN RADIAL HEAD LOCK SCREW, 24MMCatalog 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.