Latitude™ EV 0030403Recalls & reported problems
Tornier, Inc. · Humeral Stem - Coated · Class 2 · Implant
All models of Latitude EV (24)
Data updated Oct 18, 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 00846832002801), received between Oct 10, 2025 and Oct 10, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Implant Pain1
- Inadequate Osseointegration1
- Loss of Range of Motion1
- Swelling/ Edema1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, THE PATIENT UNDERWENT OPEN REDUCTION, INTERNAL FIXATION OF FRACTURED LEFT DISTAL HUMERUS, IN 2017. SHE UNDERWENT TOTAL ELBOW REPLACEMENT ON (B)(6) 2017, USING TORNIER LATITUDE TER IMPLANTS. SHE HAS BEEN VERY HAPPY WITH THIS SURGERY UNTIL RECENT MONTHS BUT LATER PRESENTED WITH PAINFUL LEFT ELBOW, DECREASED RANGE OF MOTION, SWELLING. X-RAYS SUGGESTIVE OF POSSIBLE INFECTION AND LOOSENING. SURGERY FAILED DUE TO INFECTION. DURING SURGERY TODAY, GROSS AMOUNT OF SYNOVITIS TISSUE WAS FOUND, AND EXCISED. ULNAR COMPONENTS WERE FRANKLY LOOSE AND REMOVED BY THE SURGEON USING HIS FINGERS ONLY. MULTIPLE TISSUE SPECIMENS WERE TAKEN. HUMERAL COMPONENTS WERE STILL WELL FIXED, BUT WITH OSTEOLYSIS AROUND THE DISTAL PART OF THE PROSTHESIS. SURGEON DECIDED TO REMOVE THIS COMPONENT (WHICH WAS WELL FIXED), CLEAN OUT BOTH MEDULLARY CANALS, COPIOUS LAVAGE, AND IMPLANT REVISION SIZED EXTRA-LONG COMPONENTS. AS REPORTED, EXPLANTED COMPONENTS ARE AVAILABLE FOR RETURN. BOTH REVISION COMPONENTS CEMENTED IN USING ANTIBIOTIC CEMENT. JOINT STABLE ON REDUCTION AND WOUND CLOSED. SURGEON PERFORMED THIS, 1-STAGE REVISION ARTHROPLASTY BECAUSE OF MULTIPLE CO-MORBIDITIES THAT THE PATIENT SUFFERS FROM
Patient problems: Implant Pain; Inadequate Osseointegration; Loss of Range of Motion; Swelling/ Edema; Unspecified Infection
MAUDE report 23265542 ↗
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
- ARROW IPN037140Teleflex Incorporated · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Comprehensive® SRS / Discovery® 211251Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Arcos Modular Revision Hip System 11-301325Biomet 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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