Latitude™ - Elbow DKY211Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00846832011117), received between May 18, 2022 and Oct 8, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2024Loss of Osseointegration; Loss of Osseointegration

  ELBOW REVISION DUE TO PERIPROSTHETIC FRACTURE - SPIRAL FRACTURE OF HUMERUS DUE TO FALL. LYSIS OF ULNAR COMPONENT.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture; Osteolysis

  MAUDE report 20395381 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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) 2023, A PATIENT REQUIRED REVISION SURGERY DUE TO LYSIS AND ASEPTIC LOOSENING IN THE ULNAR AND RADIAL HEAD, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 20150469 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "POST-OPERATIVE COMPLICATION WAS NOTICED DURING THE 5-Y FOLLOW-UP VISIT. SKIN EXCORIATION HAS RESULTED IN AN OPEN WOUND, EXPOSING BOTH BONE AND THE IMPLANT, AND THE ONGOING ADVERSE EVENT HAS WORSENED. THE SURGEON CONFIRMED A CAUSAL RELATIONSHIP BETWEEN THIS COMPLICATION AND THE SURGERY PROCEDURE. HOWEVER, THIS EVENT WAS ASSESSED AS NOT RELATED TO THE IMPLANT. THE RECOMMENDED COURSE OF ACTION IS TO CONTINUE THE LONG-TERM ADMINISTRATION OF CIPROFLOXACIN AND INTRODUCE DOXYCYCLINE INTO THE TREATMENT PLAN. THE OUTCOME OF THE SITUATION IS STILL IN PROGRESS, AND AS OF NOW, THE PATIENT IS NOT INCLINED TOWARDS THE REMOVAL OF THE METALWORK."

  Patient problems: Post Operative Wound Infection

  MAUDE report 19011947 ↗
• MalfunctionOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION IN THE OPERATED AREA WHICH REQUIRED A REVISION TO REMOVE THE METAL WORK IN THE ELBOW JOINT. THE PATIENT WAS HOSPITALIZED FOR GREATER THAN 24 HOURS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15611500 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ONGOING INFECTION IN THE UPPER LIMB. THE PATIENT UNDERWENT A REMOVAL OF ELBOW IMPLANTS AND CLEAN OUT.

  Patient problems: Unspecified Infection

  MAUDE report 14428653 ↗