Latitude™ - Elbow DKY214Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00846832011148), received between Sep 5, 2024 and Nov 26, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

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.

• InjuryNov 26, 2025Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ELBOW JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. SINGLE STAGE REVISION (INCLUDES DAIR WITH MODULAR EXCHANGE AND MODULAR EXCHANGE FOR INDICATIONS OTHER THAN INFECTION).

  Patient problems: Unspecified Infection

  MAUDE report 23654369 ↗
• InjuryOct 16, 2025Unstable; Unstable

  IT WAS REPORTED THAT, THE PATIENT WOULD REQUIRE A REVISION SURGERY FOR FAILURE OF ELBOW LOCKING MECHANISM. THE PLANNED DATE OF REVISION WAS (B)(6) 2025. AS NO FURTHER INFORMATION COULD BE OBTAINED, THE REVISION SURGERY HAS BEEN CAPTURED AS IT WAS PLANNED.

  Patient problems: Insufficient Information

  MAUDE report 23316762 ↗
• InjuryOct 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT OPEN REDUCTION, INTERNAL FIXATION OF FRACTURED LEFT DISTAL HUMERUS, IN 2017. SHE UNDERWENT TOTAL ELBOW REPLACEMENT ON (B)(6) 2017, USING TORNIER LATITUDE TER IMPLANTS. SHE HAS BEEN VERY HAPPY WITH THIS SURGERY UNTIL RECENT MONTHS BUT LATER PRESENTED WITH PAINFUL LEFT ELBOW, DECREASED RANGE OF MOTION, SWELLING. X-RAYS SUGGESTIVE OF POSSIBLE INFECTION AND LOOSENING. SURGERY FAILED DUE TO INFECTION. DURING SURGERY TODAY, GROSS AMOUNT OF SYNOVITIS TISSUE WAS FOUND, AND EXCISED. ULNAR COMPONENTS WERE FRANKLY LOOSE AND REMOVED BY THE SURGEON USING HIS FINGERS ONLY. MULTIPLE TISSUE SPECIMENS WERE TAKEN. HUMERAL COMPONENTS WERE STILL WELL FIXED, BUT WITH OSTEOLYSIS AROUND THE DISTAL PART OF THE PROSTHESIS. SURGEON DECIDED TO REMOVE THIS COMPONENT (WHICH WAS WELL FIXED), CLEAN OUT BOTH MEDULLARY CANALS, COPIOUS LAVAGE, AND IMPLANT REVISION SIZED EXTRA-LONG COMPONENTS. AS REPORTED, EXPLANTED COMPONENTS ARE AVAILABLE FOR RETURN. BOTH REVISION COMPONENTS CEMENTED IN USING ANTIBIOTIC CEMENT. JOINT STABLE ON REDUCTION AND WOUND CLOSED. SURGEON PERFORMED THIS, 1-STAGE REVISION ARTHROPLASTY BECAUSE OF MULTIPLE CO-MORBIDITIES THAT THE PATIENT SUFFERS FROM

  Patient problems: Implant Pain; Inadequate Osseointegration; Loss of Range of Motion; Swelling/ Edema; Unspecified Infection

  MAUDE report 23265544 ↗
• InjuryNov 7, 2024Unstable; 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 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) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 20636734 ↗
• 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) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE AND ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 20143556 ↗