FLEX SHOULDER SYSTEM DWF421BRecalls & reported problems
Tornier · Class 2 · Implant
All models of FLEX SHOULDER SYSTEM (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386940866), received between Jan 31, 2017 and Nov 24, 2021 — classified as 4 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated2
Patient problems
- Patient Problem/Medical Problem2
- Failure of Implant1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT UNDERWENT A FIRST REVISION SURGERY DUE TO INSTABILITY/DISLOCATION ON (B)(6) 2017. THE ASSOCIATED ADVERSE EVENT DATED (B)(6) 2017 DESCRIBES A DISLOCATED REVERSE WITH A DEFINITE RELATEDNESS TO THE SURGICAL PROCEDURE AND NO RELATEDNESS TO THE STUDY DEVICE.
Patient problems: Failure of Implant
MAUDE report 12867145 ↗InjuryMar 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
"IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN 2 YEARS POST OPERATIVE. SUBJECT ID: (B)(6).
Patient problems: Pain; Patient Problem/Medical Problem
MAUDE report 8439243 ↗InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
"IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO INFECTION, 20 MONTHS POST-OP. PATIENT ID: (B)(6)".
Patient problems: Unspecified Infection
MAUDE report 7048087 ↗InjuryJan 31, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AT 2.5 MONTHS POST-OPERATIVE DUE TO INSTABILITY/DISLOCATION. ONLY THE INSERT AND THE TRAY WERE CHANGED DURING THE REVISION SURGERY.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6289791 ↗
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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