Tornier Flex Shoulder System DWF391CRecalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03700434021240), received between May 3, 2022 and Oct 17, 2024 — classified as 7 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 Dislocated5
- Unstable3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Joint Dislocation3
- Failure of Implant2
- Fall1
- Joint Laxity1
- Limb Fracture1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryOct 17, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
AS REPORTED: "STUDY: SHOUT SUBJECT: 101-00039-1REV. INSTABILITY/DISLOCATION. PATIENT REQUIRED REVISION SURGERY."
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 20468794 ↗InjuryAug 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE IMPLANT GOT DISLOCATED AND SURGEON REMOVED THE POLY AND REVERSE INSERT AND PLACE NEW IMPLANTS TO COMPLETE THE SURGERY.
Patient problems: Joint Dislocation
MAUDE report 19950651 ↗InjuryMay 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY PERFORMED INVOLVING THE REMOVAL OF STRYKER/TORNIER PRODUCTS, SPECIFICALLY THE GLENOSPHERE, TRAY, AND POLY IMPLANTS, DUE TO PATIENT DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 19316007 ↗InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION".
Patient problems: Unspecified Infection
MAUDE report 19206238 ↗InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD A REVISION DUE TO A PERI-PROSTHETIC FRACTURE FOLLOWING A FALL. A REVIVE SYSTEM WAS PLACED TO BYPASS THE FRACTURE.
Patient problems: Fall; Limb Fracture
MAUDE report 16268921 ↗InjuryMay 3, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2021. RECENTLY, THE PATIENT EXPERIENCED INSTABILITY OF THIS PROSTHETIC JOINT. TWICE DISLOCATED IN RECENT FORTNIGHT. SURGEON EXAMINED SHOULDER / MANIPULATION UNDER ANESTHETIC - DEMONSTRATED INSTABILITY. RADIOGRAPHICALLY, THE PROSTHESIS APPEARED WELL POSITIONED.
Patient problems: Failure of Implant
MAUDE report 14271673 ↗InjuryMay 3, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2021. RECENTLY, THE PATIENT EXPERIENCED INSTABILITY OF THIS PROSTHETIC JOINT. SURGEON EXAMINED SHOULDER / MANIPULATION UNDER ANESTHETIC - DEMONSTRATED INSTABILITY. RADIOGRAPHICALLY, THE PROSTHESIS APPEARED WELL POSITIONED. THE PHYSICIAN THEN OPENED THE SHOULDER - SURGEON REMOVED POLY (6MM REVERSED INSERT, DWF391C), 0MM REVERSED TRAY (DWF510) AND 39MM LAT GLENOSPHERE (DWH905). IMPLANTED A 42MM GLENOSPHERE, +6MM REVERSED TRAY AND AN INSERT.
Patient problems: Failure of Implant
MAUDE report 14270238 ↗
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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