LATITUDE EV™ 0830819Recalls & reported problems
Tornier, Inc. · Radial Stem · Class 2 · Implant
- 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 00846832072460), received between Mar 17, 2023 and Nov 26, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Migration1
- Osseointegration Problem1
Patient problems
- Implant Pain1
- Inadequate Osseointegration1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 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THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ELBOW JOINT REPLACEMENT.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 23654370 ↗InjuryMar 17, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration
IT WAS REPORTED THAT THE PATIENT HAD POST-OPERATIVE COMPLICATION OF COMPONENT LOOSENING. "SINCE (B)(6) 2022, PROBABLY AFTER MUSCULATION EFFORTS, INTENSE PAIN IN THE LEFT ELBOW. X-RAYS SHOW A LOOSENING OF THE HUMERAL IMPLANT (STEM) AND LATERAL DEVIATION OF THE RADIAL IMPLANT. THE PATIENT EXPERIENCED PAIN ON HIS PROSTHESIS WHEN PRACTICING WEIGHTLIFTING, AND DURING A MOVE. HE DID NOT REALLY FOLLOW THE PRECAUTIONARY INSTRUCTIONS AND AVOIDANCE OF CARRYING LOADS. THE PATIENT UNDERWENT A REVISION TO REMOVE THE RADIAL IMPLANT AND CHANGE THE HUMERAL IMPLANT. THE AO CLASSIFICATION DOES NOT APPLY TO BONE LOSS OF THE HUMERUS, ULNA AND RADIUS (AFTER 7 INTERVENTIONS FOLLOWING AN OPEN FRACTURE IN 2013 BY MOTORCYCLE ACCIDENT). THIS IS WELL BEYOND C3.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 16567958 ↗
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™ EV 0030221Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
- Latitude™ - Elbow DKY082Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.