TORNIER SIMPLICITI HUM HEADSIZE 4 3X16
Received Feb 17, 2026 · Event occurred Nov 21, 2025
Report 0001649390-2026-00153 · MDR key 24364511
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No
Manufacturer
Tornier IncCatalog number
7122870
Lot number
0253AX
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
THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED, AND NO OTHER EVIDENCES WERE PROVIDED 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. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE INFORMATION AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE EXACT ROOT CAUSE OF THE ALLEGED FAILURE. IF ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.
Additional Manufacturer Narrative
UPON COMPLETION OF THE INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
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.