Tornier Flex Shoulder System DWF422ARecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700434020328), received between Apr 26, 2022 and Sep 25, 2024 — classified as 3 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
- Adverse Event Without Identified Device or Use Problem1
- Unstable1
Patient problems
- Fall1
- Joint Dislocation1
- Joint Laxity1
- Loss of Range of Motion1
- No Clinical Signs, Symptoms or Conditions1
- Subluxation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
AS REPORTED: "STUDY: SHOUT SUBJECT: (B)(6). POST-OPERATIVE AE: : INSTABILITY ¿ DISLOCATION SUBJECT LIFTED LARGE WATER BOTTLE ON (B)(6) 2024 AND FELT A POP. IMAGING SHOWED DISLOCATED RSA. PATIENT REQUIRED REVISION SURGERY. RE-OPERATION WITH COMPONENT CHANGE ON (B)(6) 2024".
Patient problems: Joint Laxity; Subluxation
MAUDE report 20298698 ↗InjuryMay 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY WITH REMOVAL OF TWO PROSTHETIC COMPONENTS FROM PREVIOUS REVERSE SHOULDER ARTHROPLASTY. AEQUALIS ASCEND FLEX TRAY AND INSERT WERE REMOVED AND ALL OTHER COMPONENTS RETAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14413120 ↗InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT FELL ON ICE AND GOT A DISLOCATED SHOULDER. THE EMERGENCY ROOM WAS UNABLE TO RELOCATE SHOULDER SO THE PATIENT STAYED OVERNIGHT AND THEN WAS TAKEN TO THE OPERATING ROOM NEXT MORNING FOR RELOCATION UNDER ANESTHESIA. THE PATIENT REMAINS PSEUDOPARALYTIC AND WILL BE WORKED UP FOR A REVISION RSA.
Patient problems: Fall; Joint Dislocation; Loss of Range of Motion
MAUDE report 14206450 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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