PERFORM COCR HUMERAL HEAD 50X16
Received May 29, 2026 · Event occurred May 1, 2026
Report 0001649390-2026-00496 · MDR key 25329286
Device
Generic name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Manufacturer
Tornier IncCatalog number
DWN5016
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
55 YR · Male
- Pain
Narrative
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.
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.