InjuryPKC
UNKNOWN SIMPLICITI NUCLEUS
Received Dec 9, 2025 · Event occurred Oct 6, 2025
Report 0001649390-2025-00930 · MDR key 23758927
Device
Generic name
Total Anatomic Shoulder Uncemented Metaphyseal Humeral Prosthesis
Manufacturer
Tornier IncCatalog number
UNK_WTB
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Muscle/Tendon Damage
- Muscle/Tendon Damage
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem
A REVISION SURGERY OCCURRED TO A RUPTURED SUBSCAPULARIS TENDON.