InjuryKWS
TORNIER FLEX SHOULDER SYS REV TRAY 0TH 3.5MM OFFSET
Received Jul 9, 2026 · Event occurred Jun 18, 2026
Report 3000931034-2026-00573 · MDR key 25765012
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Tornier S.a.s.Catalog number
DWF520
Lot number
8958BA
Product problems
- Device Dislodged or Dislocated
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
NA · Unknown
- Joint Dislocation
- Joint Laxity
Narrative
Description of Event or Problem
DURING MONTHLY FOLLOW-UP, IT HAS BEEN OBSERVED THAT THE POSITION OF THE TORNIER FLEX TRAY CHANGES, APPEARING AS IF THE TRAY IS NOT FIXED AND IS ROTATING.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.