Latitude™ - Elbow DKY191Recalls & reported problems
Tornier, Inc. · Humeral Screw · Class 2 · Implant
All models of Latitude - Elbow (35)
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 00846832012459), received between Nov 4, 2022 and Nov 4, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Implant Pain1
- Post Operative Wound Infection1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION IN THE OPERATED AREA WHICH REQUIRED A REVISION TO REMOVE THE METAL WORK IN THE ELBOW JOINT. THE PATIENT WAS HOSPITALIZED FOR GREATER THAN 24 HOURS.
Patient problems: Implant Pain; Post Operative Wound Infection; Swelling/ Edema
MAUDE report 15730482 ↗
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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