PERFORM CENTERED HUMERAL HEAD COUPLER TI
Received May 29, 2026 · Event occurred May 1, 2026
Report 0001649390-2026-00497 · MDR key 25329294
Device
Generic name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Manufacturer
Tornier IncCatalog number
DWT100
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
55 YR · Male
- 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. UNEXPECTED PAIN NOT RELATED TO SURGICAL RECOVERY. PATIENT REPORTED SHOULDER PAIN. PAIN FOUND TO BE RELATED TO PATIENT'S WORKOUT ROUTINE.