Tornier Flex Shoulder System DWH150Recalls & reported problems
Tornier · Tornier Pyrocarbon Humeral Head · Class 2 · Implant
All models of Tornier Flex Shoulder System (91)
Data updated Oct 18, 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 03700434020267), received between Feb 24, 2026 and Sep 17, 2026 — classified as 3 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Erosion2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement. The report details analysis provided for revision procedures performed until (b)(6) 2026.During the review of the report, it was identified that on (b)(6) 2025 a patient required revision surgery due to unexplained pain, which was not previously reported to the manufacturer.
Patient problems: Pain
MAUDE report 50803920 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO NATIVE GLENOID SURFACE EROSION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Erosion
MAUDE report 24560656 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE HEMI SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED IN 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO NATIVE GLENOID SURFACE EROSION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Erosion
MAUDE report 24428725 ↗
Other Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis devices
- Tornier Flex Shoulder System DWH146Tornier · Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis6 reports
- Tornier Flex Shoulder System DWH043Tornier · Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis5 reports
- Tornier Flex Shoulder System DWH046Tornier · Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis5 reports
- Tornier Flex Shoulder System DWH151Tornier · Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis4 reports
- Tornier Flex Shoulder System DWH139Tornier · Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis3 reports
- Tornier Flex Shoulder System DWH152Tornier · Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis2 reports
- Tornier Flex Shoulder System DWH148Tornier · Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis2 reports
- Tornier Flex Shoulder System DWH143Tornier · Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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