FLEX SHOULDER SYSTEM DWF046Recalls & 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
- 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 03700386940057), received between Sep 27, 2016 and Sep 1, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
Patient problems
- Patient Problem/Medical Problem2
- Joint Dislocation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AFTER THE INITIAL SURGERY OF AEQUALIS PERFORM GLENOID TSA ON (B)(6) 2019, THE GLENOID IMPLANT DISLODGED DUE TO LOOSENING. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED. AFTER REMOVAL OF THE PEGGLENOID AND THE HEAD IMPLANT, THE 4B STEM WAS LEFT IN PLACE AND REPLACED WITH RSA. A NEW INSERT (DWF361B), TRAY (DWF510), BASE PLATE (DWD170) AND GLENOID SPHERE (DWD180) WERE USED. NOTE: THE CURRENT REPORT IS LINKED TO EMDR FORM # 3000931034-2020-00103 (OUR REFERENCE COMP-2020-1649).
Patient problems: Joint Dislocation
MAUDE report 10475988 ↗InjuryDec 13, 2018Break; Break
"IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR GLENOID COMPONENT BREAKAGE 4 YEARS POST-OPERATIVE. SUBJECT ID: (B)(6)".
Patient problems: Patient Problem/Medical Problem
MAUDE report 8159460 ↗InjurySep 27, 2016Adverse 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 FOR ROTATOR CUFF INSUFFICIENCY. CONVERSION TO REVERSE SHOULDER ARTHROPLASTY.
Patient problems: Patient Problem/Medical Problem
MAUDE report 5979365 ↗
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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