Latitude™ - Elbow DKY184Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
All models of Latitude - Elbow (35)
Data updated Oct 18, 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 00846832012428), received between Sep 26, 2023 and Sep 5, 2024 — 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. 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
- Migration1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration2
- Bone Fracture(s)1
- Implant Pain1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2024Osseointegration Problem; Osseointegration Problem
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE AND ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Bone Fracture(s); Inadequate Osseointegration
MAUDE report 20143559 ↗InjurySep 26, 2023Migration; Migration
AS REPORTED: "PATIENT UNDERWENT "LEFT ELBOW HEMIOPROSTHESIS SURGERY (WRIGHT)" FOR "DISPLACED LEFT ELBOW CLOSED FRACTURE; SEQUELAE OF CONTUSIONS". DUE TO THE CONSTANT PAIN SHE COMPLAINED OF OVER THE FOLLOWING MONTHS, SHE WAS REFERRED TO ANOTHER FACILITY WHERE THE PROBABLE MOBILIZATION OF THE IMPLANT WAS DETECTED AND A FURTHER SURGERY WAS THEREFORE PERFORMED FOR DEFECTIVE HUMERAL WITH ENDOHUMERAL CONSOLIDATION."
Patient problems: Implant Pain; Inadequate Osseointegration; Nonunion/Delayed-union Bone Fracture
MAUDE report 17815798 ↗
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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