LATITUDE EV™ 0030711Recalls & 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
- 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 00846832074754), received between Oct 17, 2023 and Nov 26, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Unstable” (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
- Unstable1
Patient problems
- Bone Fracture(s)1
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; 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THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ELBOW JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. SINGLE STAGE REVISION (INCLUDES DAIR WITH MODULAR EXCHANGE AND MODULAR EXCHANGE FOR INDICATIONS OTHER THAN INFECTION).
Patient problems: Unspecified Infection
MAUDE report 23654366 ↗InjuryOct 16, 2025Unstable; Unstable
IT WAS REPORTED THAT, THE PATIENT WOULD REQUIRE A REVISION SURGERY FOR FAILURE OF ELBOW LOCKING MECHANISM. THE PLANNED DATE OF REVISION WAS (B)(6) 2025. AS NO FURTHER INFORMATION COULD BE OBTAINED, THE REVISION SURGERY HAS BEEN CAPTURED AS IT WAS PLANNED.
Patient problems: Insufficient Information
MAUDE report 23316767 ↗InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "INTRA-OPERATIVE COMPLICATIONS DURING THE INITIAL SURGERY INVOLVING THE LATITUDE EV IMPLANT. THE PATIENT HAD MEDIAL COLUMN FRACTURE DURING THE SURGERY. THE SURGEON CONFIRMED A CAUSAL RELATIONSHIP BETWEEN THIS FRACTURE AND THE SURGERY PROCEDURE. HOWEVER, THIS EVENT IS NOT RELATED TO THE IMPLANT. NO ACTIONS WERE NEEDED TO ADDRESS THE ISSUES. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2023". UPDATE ON (B)(6) 2023 : THE OPERATED ELBOW WAS THE LEFT. HAND DOMINANCE = OPPOSITE. THERE WAS NO INCREASE IN THE OPERATION TIME.
Patient problems: Bone Fracture(s)
MAUDE report 17952632 ↗
Other PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED devices
- DJO SURGICAL 540-00-000Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED64 reports
- Arcos Modular Revision Hip System 11-301321Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall7 reports
- DJO SURGICAL 540-01-001Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED55 reports
- Arcos Modular Revision Hip System 11-301302Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall5 reports
- Arcos Modular Revision Hip System 11-301343Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall1 report
- Bearing and Axle Bushing Assembly - Standard Elbow C-M113-1-301Howmedica Osteonics Corp. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Comprehensive® SRS / Discovery® 211251Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Comprehensive® SRS / Discovery® 211253Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 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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