LATITUDE EV™ 0030710Recalls & 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 00846832074747), received between Jan 3, 2024 and Jan 30, 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
- Implant Pain2
- Cramp(s) /Muscle Spasm(s)1
- Inflammation1
- Loss of Range of Motion1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "WELBOW SUBJECT (B)(6). ONE-MONTH POST-SURGERY INVOLVING THE TOTAL LATITUDE IMPLANT, THE PATIENT EXPERIENCED PERSISTENT AND ABNORMAL PAIN, ACCOMPANIED BY HEIGHTENED STIFFNESS. NOTABLY, THERE IS A MARKED REDUCTION IN THE PATIENT'S RANGE OF MOTION, WITH INCREASED VIGILANCE REQUIRED DUE TO THE EMERGENCE OF AGGRESSIVE MUSCLE CONTRACTIONS IN THE BRACHIO-RADIAL MUSCLE. FURTHERMORE, THERE IS A PRONOUNCED RIGIDITY OBSERVED DURING FLEXION, EMPHASIZING THE NEED FOR CLOSE MONITORING AND PROMPT INTERVENTION. TO ADDRESS THIS ISSUE EFFECTIVELY, A COMPREHENSIVE REHABILITATION PROGRAM FEATURING GENTLE KINETHERAPY AND TARGETED MUSCLE MASSAGE WERE PRESCRIBED. ADDITIONALLY, A PROCEDURE INVOLVING THE REMOVAL OF THE SPLINT AT A 90° FLEXION ANGLE WAS CARRIED OUT TO AUGMENT THE OVERALL TREATMENT STRATEGY. THIS EVENT WAS RESOLVED WITHOUT SEQUELAE."
Patient problems: Cramp(s) /Muscle Spasm(s); Implant Pain; Loss of Range of Motion
MAUDE report 18610598 ↗InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT EXPERIENCED HEIGHTENED PAIN DURING MAXIMUM FLEXION, ACCOMPANIED BY SLIGHTLY ELEVATED INFLAMMATORY MARKERS. A CT SCAN REVEALED SIGNS OF INFECTION AROUND THE TIP OF THE ULNAR PROSTHESIS. FOLLOWING A CONSULTATION, A SPECT CT SCAN WAS ORDERED FOR FURTHER ASSESSMENT. THE SURGEON INDICATED THAT THE INFECTION IS NOT DIRECTLY LINKED TO THE IMPLANT BUT IS ASSOCIATED WITH THE INITIAL SURGERY.
Patient problems: Implant Pain; Inflammation; Unspecified Infection
MAUDE report 18440264 ↗
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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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