Tornier Flex Shoulder SystemRecalls & reported problems across all models
Tornier · 91 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 791
- Deaths reported
- 0
- Injuries reported
- 787
- Recalls
- 0
We found 91 models of Tornier Flex Shoulder System by Tornier in the FDA's device registry (GUDID). Together they are named in 791 adverse event reports in the FDA's MAUDE database, received between Aug 17, 2021 and Sep 21, 2026 — classified as 787 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (163 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Tornier Flex Shoulder System problems
Device problems
- Adverse Event Without Identified Device or Use Problem500
- Device Dislodged or Dislocated163
- Unstable94
- Osseointegration Problem32
- Migration22
- Loss of Osseointegration21
- Fracture12
- Off-Label Use7
Patient problems
- Unspecified Infection242
- Joint Dislocation105
- Joint Laxity99
- Implant Pain89
- Subluxation66
- Bone Fracture(s)51
- Loss of Range of Motion51
- Pain40
Tornier Flex Shoulder System models
91 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tornier Flex Shoulder System DWF510PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED108 reports
- Tornier Flex Shoulder System DWF361BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED83 reports
- Tornier Flex Shoulder System DWF520PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED66 reports
- Tornier Flex Shoulder System DWF603BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED52 reports
- Tornier Flex Shoulder System DWF391BPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED39 reports
- Tornier Flex Shoulder System DWF421BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED32 reports
- Tornier Flex Shoulder System DWF602BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED28 reports
- Tornier Flex Shoulder System DWF604BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED27 reports
- Tornier Flex Shoulder System DWF605BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED25 reports
- Tornier Flex Shoulder System DWF712BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- Tornier Flex Shoulder System DWF500PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED15 reports
- Tornier Flex Shoulder System DWF603APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED15 reports
- Tornier Flex Shoulder System DWF392BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED14 reports
- Tornier Flex Shoulder System DWF362BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED14 reports
- Tornier Flex Shoulder System DWF601BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED14 reports
- Tornier Flex Shoulder System DWF422BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED10 reports
- Tornier Flex Shoulder System DWF361CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED9 reports
- Tornier Flex Shoulder System DWF602APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- Tornier Flex Shoulder System DWF046PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- Tornier Flex Shoulder System DWF604CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- Tornier Flex Shoulder System DWF391CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- Tornier Flex Shoulder System DWF604APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- Tornier Flex Shoulder System DWF364BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- Tornier Flex Shoulder System DWF143PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- Tornier Flex Shoulder System DWF606BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- Tornier Flex Shoulder System DWH146Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis6 reports
- Tornier Flex Shoulder System DWF043PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- Tornier Flex Shoulder System DWH043Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis5 reports
- Tornier Flex Shoulder System DWF603CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED5 reports
- Tornier Flex Shoulder System DWF521PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED5 reports
- Tornier Flex Shoulder System DWH046Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis5 reports
- Tornier Flex Shoulder System DWF425BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED5 reports
- Tornier Flex Shoulder System DWF511PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Tornier Flex Shoulder System DWF714BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Tornier Flex Shoulder System DWH151Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis4 reports
- Tornier Flex Shoulder System DWF394BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Tornier Flex Shoulder System DWF421CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Tornier Flex Shoulder System DWF151PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Tornier Flex Shoulder System DWF051PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Tornier Flex Shoulder System DWF146PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Tornier Flex Shoulder System DWF425CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Tornier Flex Shoulder System DWF365BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Tornier Flex Shoulder System DWH139Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis3 reports
- Tornier Flex Shoulder System DWF424BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Tornier Flex Shoulder System DWH150Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis3 reports
- Tornier Flex Shoulder System DWF422APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Tornier Flex Shoulder System DWF606APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Tornier Flex Shoulder System DWF395BPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED3 reports
- Tornier Flex Shoulder System DWF605CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Tornier Flex Shoulder System DWF607BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Tornier Flex Shoulder System DWF601APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Tornier Flex Shoulder System DWF613BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Tornier Flex Shoulder System DWF150PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Tornier Flex Shoulder System DWF041PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Tornier Flex Shoulder System DWF608BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Tornier Flex Shoulder System DWF612BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Tornier Flex Shoulder System DWF606CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Tornier Flex Shoulder System DWF148PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Tornier Flex Shoulder System DWF356BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Tornier Flex Shoulder System DWF392Cshoulder prosthesis, reverse configuration2 reports
- Tornier Flex Shoulder System DWF602CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Tornier Flex Shoulder System DWH152Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis2 reports
- Tornier Flex Shoulder System DWF048PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Tornier Flex Shoulder System DWH143Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis2 reports
- Tornier Flex Shoulder System DWF139PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Tornier Flex Shoulder System DWF607CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Tornier Flex Shoulder System DWF601CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Tornier Flex Shoulder System DWH148Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis2 reports
- Tornier Flex Shoulder System DWF605APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Tornier Flex Shoulder System DWF607APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Tornier Flex Shoulder System DWG050PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWG143PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWG154PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWH141Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis1 report
- Tornier Flex Shoulder System DWF522PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWH048Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis1 report
- Tornier Flex Shoulder System DWF152PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWF615BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWH051Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis1 report
- Tornier Flex Shoulder System DWH039Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis1 report
- Tornier Flex Shoulder System DWF391Ashoulder prosthesis, reverse configuration1 report
- Tornier Flex Shoulder System DWH154Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis1 report
- Tornier Flex Shoulder System DWF616BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWF039PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWF702APROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWH050Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis1 report
- Tornier Flex Shoulder System DWF611BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWF364CPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWF512PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWF141PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Tornier Flex Shoulder System DWF704BPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
Recent Tornier Flex Shoulder System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
A revision surgery was performed as a result of a suspected infection after the patient fell.
Patient problems: Fall; Post Operative Wound Infection
MAUDE report 50841163 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
A revision surgery was performed as a result of a suspected infection after the patient fell.
Patient problems: Fall; Post Operative Wound Infection
MAUDE report 50841162 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fall; Post Operative Wound Infection
MAUDE report 50841156 ↗InjurySep 18, 2026Device Dislodged or Dislocated
Patient problems: Osteolysis; Subluxation
MAUDE report 50819505 ↗InjurySep 18, 2026Loss of Osseointegration
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 Aug 2026.During the review of the report, it was identified that on(b)(6)2026 a patient required revision surgery due to ASEPTIC LOOSENING HUMERUS, which was not previously reported to the manufacturer.
Patient problems: Osteolysis
MAUDE report 50819213 ↗InjurySep 18, 2026Loss of Osseointegration
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)-2026 a patient required revision surgery due to ASEPTIC LOOSENING HUMERUS, which was not previously reported to the manufacturer.
Patient problems: Osteolysis
MAUDE report 50815435 ↗InjurySep 18, 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 (b)(6) 2026.During the review of the report, it was identified that on (b)(6)2026 a patient required revision surgery due to native glenoid surface erosion & unexplained pain, which was not previously reported to the manufacturer.
Patient problems: Erosion
MAUDE report 50813793 ↗InjurySep 17, 2026Unstable
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) 2026 a patient required revision surgery due to instability, which was not previously reported to the manufacturer.
Patient problems: Joint Laxity
MAUDE report 50803922 ↗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 ↗InjurySep 17, 2026Unstable
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) 2026 a patient required revision surgery due to instability, which was not previously reported to the manufacturer.
Patient problems: Joint Laxity
MAUDE report 50803917 ↗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 Aug 2026.During the review of the report, it was identified that on (b)(6) 2026 a patient required revision surgery due to periprosthetic fracture humeral side, which was not previously reported to the manufacturer.
Patient problems: Bone Fracture(s)
MAUDE report 50803915 ↗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 50803912 ↗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 Aug 2026.During the review of the report, it was identified that on (b)(6) 2026 a patient required revision surgery due to native glenoid surface erosion & unexplained pain, which was not previously reported to the manufacturer.
Patient problems: Pain
MAUDE report 50803911 ↗InjurySep 17, 2026Unstable
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) 2026 a patient required revision surgery due to instability, which was not previously reported to the manufacturer.
Patient problems: Joint Laxity
MAUDE report 50803909 ↗InjurySep 17, 2026Unstable
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 Aug 2026.During the review of the report, it was identified that on 27-Mar-2026 a patient required revision surgery due to instability, which was not previously reported to the manufacturer.
Patient problems: Joint Laxity
MAUDE report 50803908 ↗
Other Tornier products
- Blueprint Mixed Reality8 models · 0 reports · 9 recalls
- AEQUALIS REVERSED II46 models · 405 reports
- AEQUALIS REVERSED41 models · 258 reports
- FLEX SHOULDER SYSTEM35 models · 194 reports
- Tornier Perform Anatomic Glenoid25 models · 81 reports
- Aequalis Ascend Flex30 models · 79 reports
- AEQUALIS15 models · 56 reports
- Blueprint4 models · 0 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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