TORNIER SIMPLICITI HUM HEADSIZE 5 2X23
Received Aug 28, 2025 · Event occurred Aug 6, 2025
Report 0001649390-2025-00602 · MDR key 22913092
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem
Manufacturer
Tornier IncCatalog number
7122876
Lot number
8454AX
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
64 YR · Male
- Muscle/Tendon Damage
- Muscle/Tendon Damage
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, THE REVISION SURGERY WAS PERFORMED IN WHICH ANATOMIC SHOULDER WAS REVISED TO REVERSE DUE TO SUBSCAPULARIS REPAIR FAILING. NO IMPLANT FAILURE WAS NOTED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative
THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.
Description of Event or Problem
IT WAS REPORTED THAT, THE REVISION SURGERY WAS PERFORMED IN WHICH ANATOMIC SHOULDER WAS REVISED TO REVERSE DUE TO SUBSCAPULARIS REPAIR FAILING. NO IMPLANT FAILURE WAS NOTED.