TORNIER FLEX SHOULDER SYS REV TRAY 0TH 1.5MM OFFSET
Received Jul 17, 2026 · Event occurred Jun 22, 2026
Report 3000931034-2026-00579 · MDR key 25861982
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Tornier S.a.s.Catalog number
DWF510
Lot number
9924AZ
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
UPON COMPLETION OF THE INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE INVOLVING A REVIVE STEM. DURING THE REVISION, THE PROXIMAL BODY, ASSEMBLY SCREW, LOCKING CAP, POLYETHYLENE INSERT, AND ASCEND FLEX TRAY WERE REMOVED. THE DISTAL STEM REMAINED IN SITU. THE PROXIMAL SECTION WAS REPLACED WITH NEW COMPONENTS, INCLUDING UPSIZING THE PROXIMAL BODY TO A SIZE 11.