Tornier Flex Shoulder System DWF601ARecalls & 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 03700434021646), received between Mar 23, 2024 and Feb 26, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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
- Loss of Osseointegration1
- Material Erosion1
Patient problems
- Bone Fracture(s)1
- Erosion1
- Fall1
- Limb Fracture1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2025Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; Adverse 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THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL FEBRUARY 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE AND NATIVE GLENOID SURFACE EROSION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: REVISION STEMMED TOTAL REVERSE ARTHROPLASTY.
Patient problems: Bone Fracture(s); Erosion
MAUDE report 21469197 ↗InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OF HUMERAL COMPONENTS DUE TO PERIPROSTHETIC FRACTURE CAUSE BY PATIENT FALL. THE HUMERAL COMPONENTS WERE REMOVED, AND REPLACED WITH A AEQUALIS FLEX REVIVE STEM, THE FRACTURE REDUCED TO THIS REVISION STEM. NO ISSUE WITH IMPLANTS.
Patient problems: Fall; Limb Fracture
MAUDE report 20292508 ↗InjuryMar 23, 2024Loss of Osseointegration; Loss of Osseointegration
BONY RESORPTION ALONG THE GREATER TUBEROSITY AND AN ENLARGING EFFUSION AROUND THE PROXIMAL HUMERUS WERE OBSERVED. A REVISION SURGERY WAS CONDUCTED, REMOVING COMPONENTS SUCH AS THE TRAY, STEM, GLENOSPHERE, AND INSERT. THE RELATEDNESS TO THE STUDY DEVICE WAS DEFINITE, WHILE ITS RELATION TO THE SURGICAL PROCEDURE WAS CONSIDERED POSSIBLE.
Patient problems: Osteopenia/ Osteoporosis
MAUDE report 18965266 ↗
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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