InjuryPKC
TORNIER SIMPLICITI NUCLEUS SIZE 2
Received Apr 23, 2026 · Event occurred Mar 20, 2026
Report 0001649390-2026-00375 · MDR key 24968494
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem
Manufacturer
Tornier IncCatalog number
7122866
Lot number
CC0125041
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR · Female
- Fall
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, THE SURGEON REMOVED A SIMPLICITI/PERFORM ANATOMIC CONSTRUCT DUE TO PATIENT HAVING A POST OPERATION FALL WHICH MEANT HAVING TO CHANGE TO A REVERSE SHOULDER CONSTRUCT. THE IMPLANTS WERE NOT DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.