Latitude™ - Elbow DKY121Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832010981), received between Jan 30, 2024 and Oct 16, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Break; Fracture; Unstable; Break; Fracture; Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER ELBOW SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2018 ¿ (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY; BREAKAGE, DISSOCIATION OF PROSTHESIS, RADIAL HEAD, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 20460580 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: (B)(4). 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 18610605 ↗