Latitude™ EV 0030502Recalls & reported problems
Tornier, Inc. · Humeral 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 00846832002856), received between Jul 17, 2024 and Aug 29, 2024 — classified as 2 injuries.
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
Patient problems
- Bone Fracture(s)1
- Implant Pain1
- Skin Inflammation/ Irritation1
- Swelling/ Edema1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). WELBOW CLINICAL STUDY. POST-OPERATIVE COMPLICATION: ¿FRACTURE OF ANY PART OF THE OPERATED ARM¿. FIVE YEARS AFTER THE INITIAL SURGERY INVOLVING THE LATITUDE EV IMPLANT, THE PATIENT PRESENTED TO THEIR LOCAL GENERAL PRACTITIONER WITH PAIN AND SWELLING IN THE RIGHT ELBOW. AN X-RAY CONFIRMED THE PRESENCE OF A PERIPROSTHETIC FRACTURE. THE OUTCOME WAS REPORTED AS ¿ONGOING¿. A BACK SLAB WAS APPLIED FOR IMMOBILIZATION, AND FURTHER X-RAYS WILL BE CONDUCTED TO MONITOR THE HEALING PROGRESS AND EVALUATE THE OUTCOME.
Patient problems: Bone Fracture(s); Implant Pain; Swelling/ Edema
MAUDE report 20096489 ↗InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED: PATIENT REQUIRED ANOTHER REVISION SURGERY DUE TO INFECTION AND COMPROMISED SKIN CONDITION.
Patient problems: Skin Inflammation/ Irritation; Unspecified Infection
MAUDE report 19761000 ↗
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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