Latitude™ - Elbow DKY192Recalls & reported problems
Tornier, Inc. · Humeral Screw · Class 2 · Implant
All models of Latitude - Elbow (35)
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 00846832012466), received between Jun 12, 2024 and Aug 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
- Discomfort2
- Loss of Range of Motion2
- Implant Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISCOMFORT AND STIFFNESS AND REDUCED RANGE OF MOTION. ALL PROSTHESIS REMOVED, AND DISCARDED. SPECIMENS TAKEN FOR PATHOLOGY. ALL ORIGINAL BONE CEMENT REMOVED. COPIOUS LAVAGE ATTENDED. ALL JOINT AND MEDULLARY CANAL SURFACES IRRIGATED WITH AQUEOUS BETADINE. FULL SET OF PROSTHESIS CEMENTED IN, WITH ANTIBIOTIC CEMENT.
Patient problems: Discomfort; Implant Pain; Loss of Range of Motion
MAUDE report 20108283 ↗InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: PRIMARY RIGHT ELBOW REPLACEMENT BY SURGEON, ON (B)(6) 2023. PATIENT COMPLAINED THAT THE SURGERY "DIDN'T FEEL QUITE RIGHT" FROM EARLY POST-OP. SURGEON REVISED PROSTHETIC JOINT ON (B)(6) 2023 SUSPECTING INFECTION, THOUGH NO ORGANISM CULTURED. FOR MOST OF LAST 12 MONTHS, PATIENT GENERALLY HAPPY WITH PROSTHETIC JOINT, BUT COMPLAINED TO SURGEON OVER RECENT MONTHS, THAT THIS ELBOW JOINT WAS CAUSING HIM MORE DISCOMFORT AND STIFFNESS. SURGEON DECIDED TO REVISE THE PROSTHETIC JOINT AGAIN. ALL PROSTHESIS REMOVED AND DISCARDED. SPECIMENS TAKEN FOR PATHOLOGY. ALL ORIGINAL BONE CEMENT REMOVED. COPIOUS LAVAGE ATTENDED. ALL JOINT AND MEDULLARY CANAL SURFACES IRRIGATED WITH AQUEOUS BETADINE. FULL SET OF PROSTHESIS CEMENTED IN, WITH ANTIBIOTIC CEMENT". THIS RECORD COVERS THE SECOND REVISION SURGERY.
Patient problems: Discomfort; Loss of Range of Motion
MAUDE report 19521891 ↗
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
- Bearing and Axle Bushing Assembly - Standard Elbow C-M113-1-301Howmedica Osteonics Corp. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Comprehensive® SRS / Discovery® 211251Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Comprehensive® SRS / Discovery® 211253Biomet 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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