Latitude™ - Elbow DKY212Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832011124), received between Sep 5, 2024 and Mar 30, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A REMOVAL OF LATITUDE EV TOTAL ELBOW REPLACEMENT WAS PERFORMED FOR A PATIENT WHO HAD AN INFECTION. THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2025. THE SURGEON ACCESSED THE JOINT AND REMOVED A SIGNIFICANT AMOUNT OF BLACK MATTER AND THEN PROCEEDED TO TAKE THE HUMERAL AND ULNAR STEM OUT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 24734944 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT LEFT TOTAL ELBOW REPLACEMENT ON (B)(6) 2025, FOLLOWING A FALL (SUSTAINED A FRACTURED LEFT DISTAL HUMERUS). PATIENT PRESENTED APPROXIMATELY 2 X WEEKS AGO TO HOSPITAL WITH PAIN, INCREASED SWELLING, REDNESS IN LEFT ELBOW JOINT: MALAISE. COMMENCED ON ANTIBIOTICS. NO IMPROVEMENT. DECISION MADE TO OPEN WOUND AND IRRIGATE SUSPECTED PROSTHETIC ELBOW JOINT INFECTION. DURING SURGERY, A LARGE COLLECTION OF PUS WAS DRAINED FROM THE LEFT ELBOW - APPROX 2 LITRES. MULTIPLE SAMPLES / SPECIMENS TAKEN. WOUND DEBRIDED. COPIOUS LAVAGE. SURGEON DECIDED TO EXCHANGE THE ULNAR CAP IMPLANT, PLUS THE HUMERAL SPOOL AND LOCKING SCREW. THESE WERE REPLACED WITHOUT DIFFICULTY. WOUND CLOSED.

  Patient problems: Unspecified Infection

  MAUDE report 23877741 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s)

  MAUDE report 20143503 ↗
• 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) 2014 A PATIENT REQUIRED REVISION SURGERY DUE FAILURE MODE FROM ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20143385 ↗