InjuryPKC
TORNIER SIMPLICITI NUCLEUS SIZE 2
Received Feb 17, 2026 · Event occurred Nov 21, 2025
Report 0001649390-2026-00156 · MDR key 24364664
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No
Manufacturer
Tornier IncCatalog number
DWG402
Lot number
CC1322157087
Product problems
- Inadequacy of Device Shape and/or Size
Patient
49 YR · Female
- Pain
Narrative
Description of Event or Problem
A REVISION SURGERY WAS PERFORMED DUE TO NON-OPTIMAL FIT OF THE COMPONENTS WHICH PLACED STRESS ON THE ROTATOR CUFF AS WELL AS PAIN.
Additional Manufacturer Narrative
UPON COMPLETION OF THE INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.