UNKNOWN SIMPLICITI HEAD
Received Jan 13, 2026 · Event occurred Dec 12, 2025
Report 0001649390-2026-00032 · MDR key 24054401
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem
Manufacturer
Tornier IncCatalog number
UNK_WTB
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELLING DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. 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, A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2025, USING THE BLUEPRINT PLANNING FEATURE. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT, A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2025, USING THE BLUEPRINT PLANNING FEATURE. NO FURTHER INFORMATION WAS PROVIDED.