Latitude™ EV 0030513Recalls & 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 00846832002887), received between Mar 17, 2023 and Mar 17, 2023 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Migration1
- Osseointegration Problem1
Patient problems
- Implant Pain1
- Inadequate Osseointegration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration
IT WAS REPORTED THAT THE PATIENT HAD POST-OPERATIVE COMPLICATION OF COMPONENT LOOSENING. "SINCE (B)(6), 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 16567959 ↗
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
- CRF II - RADIAL PROSTHESIS DTJ022Tornier · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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