InjuryPKC
TORNIER SIMPLICITI HUM HEADSIZE 5 8X18
Received Jan 10, 2025 · Event occurred Jul 3, 2018
Report 0001649390-2025-00019 · MDR key 21122536
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem
Manufacturer
Tornier IncCatalog number
7122872
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
51 YR · Male
- Implant Pain
- Implant 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
AS REPORTED: "SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY PATIENT REPORTED PAIN IN THE SHOULDER AFTER POWER WASHING".