TORNIER SIMPLICITI HUM HEADSIZE 4 3X16
Received Jan 2, 2025 · Event occurred Jun 27, 2024
Report 0001649390-2025-00002 · MDR key 21055504
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem
Manufacturer
Tornier IncCatalog number
7122870
Lot number
9280AW
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY. PLEASE NOTE, THAT REPORTS RECEIVED FROM THE NATIONAL JOINT REGISTRY ARE NOT PUBLISHED REPORTS AND THEREFORE WEB LINK IS NOT AVAILABLE.
Description of Event or Problem
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE AND CUFF INSUFFICIENCY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.