Tornier Flex Shoulder System DWH048Recalls & reported problems
Tornier · Tornier Pyrocarbon Humeral Head · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700434019544), received between Jul 17, 2025 and Jul 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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 Problem1
- Off-Label Use1
Patient problems
- Fall1
- Muscle/Tendon Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem
PT FELL OVER AND TORE SUBSCAPULARIS. SURGEON WASN¿T SURE IF HE NEEDED TO REPLACE THE HEAD.
Patient problems: Fall; Muscle/Tendon Damage
MAUDE report 22530892 ↗
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 DWH150Tornier · Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis3 reports
- Tornier Flex Shoulder System DWH143Tornier · Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis2 reports
- Tornier Flex Shoulder System DWH152Tornier · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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