Tornier Flex Shoulder System DWF392CRecalls & reported problems
Tornier · Class 2 · Implant
All models of Tornier Flex Shoulder System (91)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700434020663), received between Sep 25, 2023 and Nov 28, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Unstable1
Patient problems
- Joint Dislocation1
- Joint Laxity1
- Subluxation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
AS REPORTED: "SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY. RECENTLY UNDERWENT REVISION WITH AN ALLOGRAFT PROSTHESIS AND SUBSEQUENTLY HAD A DISLOCATION. (B)(6) 2022: INSERT, TRAY AND GLENOSPHERE WERE REPLACED DURING REVISION SURGERY DUE TO INSTABILITY- DISLOCATION. - INSERT: 39 DIA RETENTIVE +9MM/7.5C. - TRAY: CENTERED +0MM. - GLENOSPHERE: 39MM LATERALIZED (+3MM))."
Patient problems: Joint Laxity; Subluxation
MAUDE report 20804606 ↗InjurySep 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED: "PATIENT REQUIRED REVISION SURGERY DUE TO THE DEVICE DISLOCATING.'
Patient problems: Joint Dislocation
MAUDE report 17813879 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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