InjuryPKC
TORNIER SIMPLICITI NUCLEUS SIZE 2
Received Dec 31, 2024 · Event occurred Jul 3, 2018
Report 0001649390-2024-00737 · MDR key 21045908
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem
Manufacturer
Tornier IncCatalog number
DWG402
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Implant Pain
- Implant Pain
Narrative
Description of Event or Problem
AS REPORTED: "SUBJECT 008-00011 SHOUT - TORNIER SHOULDER OUTCOMES STUDY PATIENT REPORTED PAIN IN THE SHOULDER AFTER POWER WASHING".
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.