Latitude™ EV 0030031Recalls & reported problems
Tornier, Inc. · Ulnar Stem - Coated · Class 2 · Implant
All models of Latitude EV (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832002511), received between Nov 3, 2021 and Mar 30, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Failure of Implant1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, A REMOVAL OF LATITUDE EV TOTAL ELBOW REPLACEMENT WAS PERFORMED FOR A PATIENT WHO HAD AN INFECTION. THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2025. THE SURGEON ACCESSED THE JOINT AND REMOVED A SIGNIFICANT AMOUNT OF BLACK MATTER AND THEN PROCEEDED TO TAKE THE HUMERAL AND ULNAR STEM OUT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 24736415 ↗InjuryNov 3, 2021Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE ULNAR COMPONENTS DUE TO THE ULNAR STEM SNAPPING MID WAY DOWN THE STEM. THIS WAS FOUND ON AN X-RAY.
Patient problems: Failure of Implant
MAUDE report 12746104 ↗
Other PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED devices
- TEMA Elbow 1590.15.010Limacorporate SPA · Prosthesis, Elbow, Semi-Constrained, Cemented2 recalls3 reports
- TEMA Elbow 1590.15.020Limacorporate SPA · Prosthesis, Elbow, Semi-Constrained, Cemented1 recall1 report
- Latitude™ - Elbow DKY068Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED20 reports
- DURALOC 1241-46-526Depuy Orthopaedics, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED17 reports
- Latitude™ - Elbow DKY067Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED8 reports
- RHS - RADIAL PROSTHESIS DTJ302Tornier · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED6 reports
- Latitude™ - Elbow DKY082Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
- Latitude™ - Elbow DKY216Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 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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