Latitude™ - Elbow DKY067Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00846832010905), received between May 18, 2022 and Dec 23, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 23877744 ↗
• InjuryAug 12, 2025Break; Fracture; Osseointegration Problem; Break; Fracture; Osseointegration Problem

  IT WAS REPORTED THAT, THE CUSTOM LONG LENGTH ULNAR STEM WITH NO BONY SUPPORT AROUND THE OLECRANON (STRESS RISER) BROKE AT THE BONE STEM JUNCTION. REVISION PROCEDURE REQUIRED TO REIMPLANT ANOTHER LONG STEM ULNAR COMPONENT WITH ALLOGRAFT BONY SUPPORT. REVISION DUE TO BROKEN ULNAR STEM. REVISION PROCEDURE WAS SUCCESSFUL. NO X RAYS AVAILABLE AT THE MOMENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Loss of fracture reduction

  MAUDE report 22787731 ↗
• 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 (B)(6) 2012 ¿ (B)(6) 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 20143500 ↗
• 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 19011957 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A PRIMARY LEFT ELBOW REPLACEMENT. THE PATIENT HAD A HISTORY OF A CHRONIC DISCHARGING SINUS AROUND THE ELBOW'S SUTURE LINE, LEADING TO MULTIPLE DRAINAGE PROCEDURES AND SAMPLES TAKEN, BUT NO SPECIFIC ORGANISM WAS IDENTIFIED. THE DIAGNOSIS WAS ASEPTIC SYNOVITIS. THE PATIENT HAD OTHER PROSTHETIC JOINTS WITHOUT ISSUES SUCH AS METAL SENSITIVITY OR INFECTION. DURING THE PROCEDURE, A NEW STERILE COMPONENT REPLACED THE ULNA LOCKING CAP, WHILE OTHER COMPONENTS REMAINED UNCHANGED. EXTENSIVE SYNOVIAL DEBRIDEMENT WAS PERFORMED, MULTIPLE TISSUE SAMPLES WERE TAKEN, AND THE AREA WAS THOROUGHLY CLEANSED. THE SURGICAL TEAM WAS ABLE TO CLOSE THE TISSUES AND SKIN AFTER THE PROCEDURE.

  Patient problems: Fluid Discharge; Synovitis

  MAUDE report 17575404 ↗
• InjuryJul 5, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF A LATITUDE ELBOW WHEREBY THE RADIAL COMPONENT HAD LOOSENED OVER 15 YEARS, CAUSING PAIN. THE REVISION CONSISTED OF REMOVING THE RADIAL COMPONENTS AND THEN CHANGING A POLY LINER. FINALLY THE IMPLANT WAS CONSTRAINED USING AN ULNAR CAP.

  Patient problems: Implant Pain

  MAUDE report 17260374 ↗
• InjuryNov 4, 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: Implant Pain; Post Operative Wound Infection; Swelling/ Edema

  MAUDE report 15723952 ↗
• 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 14428584 ↗