PERFORM NUCLEUS FC SIZE 2 - ANATOMIC
Received Apr 8, 2026 · Event occurred Feb 19, 2026
Report 0001649390-2026-00331 · MDR key 24817179
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral System
Manufacturer
Tornier IncCatalog number
DWM002A
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
68 YR · Female
- Fall
- Pain
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
SUBJECT: (B)(6). PHS STUDY. (B)(6) 2026. TRAUMATIC FALL. PARTICIPANT SUSTAINED A FALL ON SHOULDER WHILE WALKING DOG. X-RAY AND MUSCULOSKELETAL ULTRASOUND FINDINGS DEMONSTRATE INTACT SOFT TISSUE AND NO RELATIVE CHANGES TO IMPLANT. THEY REPORT INCREASED PAIN SINCE FALL. (B)(6) 2026. PARTICIPANT WAS DRYING HAIR AND FELT "SNAP" IN SHOULDER WITH EXCRUCIATING PAIN. PHYSICAL EXAM NEGATIVE FOR SOFT TISSUE DAMAGE. WILL REPEAT MSK ULTRASOUND ON (B)(6) 2026 IF PAIN PERSISTS. UPDATE #2 ((B)(6) 2026) REPEAT MUSCULOSKELETAL ULTRASOUND NEGATIVE FOR SOFT TISSUE DAMAGE OR DEVICE ISSUES. AN UNRECOGNIZABLE MASS IS PRESENT BETWEEN LESSER AND GREATER TUBEROSITIES. UPDATE 3 ((B)(6) 2026): CT FINDINGS AND SURGERY. NOT RELATED TO DEVICE/POSSIBLY RELATED TO PROCEDURE.