Tornier Flex Shoulder System DWF613BRecalls & 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 03700434021660), received between Mar 22, 2024 and Mar 27, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Biocompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Biocompatibility1
Patient problems
- Implant Pain2
- Loss of Range of Motion2
- Bacterial Infection1
- Extraskeletal ossification1
- Fall1
- Metal Related Pathology1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FRACTURE AT THE DISTAL END OF AN ARTIFICIAL SHOULDER JOINT WAS OCCURRED DUE TO A FALL. THE REVISION SURGERY IS PLANNED.
Patient problems: Fall
MAUDE report 21713489 ↗InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PATIENT UNDERWENT SHOULDER HEMI-ARTHROPLASTY ON (B)(6) 2023, FOR FRACTURE PROXIMAL RIGHT HUMERUS. PATIENT HAS EXPERIENCED PAIN AND REDUCED RANGE OF MOTION OVER RECENT MONTHS. SURGEON SUSPECTS JOINT IS INFECTED, DUE TO 1 X SWAB RETURNING POSITIVE FOR BACTERIA C.ACNES. SURGEON HAS DECIDED ON A 2-STAGE REVISION ARTHROPLASTY. HUMERAL PROSTHESIS REMOVED, WITH SIGNIFICANT DIFFICULTY (HUMERAL STEM WELL FIXED). MULTIPLE TISSUE SPECIMENS TAKEN. EXPLANTED PROSTHESIS DISCARDED. CEMENT ANTIBIOTIC SPACER IMPLANTED."
Patient problems: Bacterial Infection; Implant Pain; Loss of Range of Motion
MAUDE report 19105749 ↗InjuryMar 22, 2024Biocompatibility; Biocompatibility
THE PATIENT REPORTED PAIN AND DECREASED FUNCTION, LEADING TO A REVISION SURGERY. THE REASON FOR THE REVISION SURGERY WAS LISTED AS HETEROTOPIC OSSIFICATION, SEVERE STIFFNESS, AND NICKEL METAL ALLERGY. COMPONENTS INCLUDING THE TRAY, INSERT, AND GLENOSPHERE WERE EXPLANTED, WHILE THE STEM, BASEPLATE, AND CENTRAL SCREW WERE RETAINED. THE RELATEDNESS TO THE STUDY DEVICE AND THE SURGICAL PROCEDURE WAS ASSESSED AS POSSIBLE.
Patient problems: Extraskeletal ossification; Implant Pain; Loss of Range of Motion; Metal Related Pathology
MAUDE report 18963718 ↗
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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