Latitude™ - Elbow DKY069Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00846832010929), received between Dec 6, 2021 and Sep 28, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Inadequate Osseointegration; Post Operative Wound Infection

  MAUDE report 50918121 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  As reported: "Irrigation and debridement periprosthetic infection right elbow, removal elbow implant and cement and insertion of antibiotic impregnated cement spacer and beads. During removal(Cement ) portion of the medial condyle fractured fractured off and was excised. A large spacer was made and intersected into the distal humerus in beads were made inserted into the proximal ulna into the anterior soft tissues...Joint was reduced, A medium Hemovac drain was placed in the depths of the wound and brought out proximally through ta lateral stab incision. Swabs was obtained intraop for aerobic Gram stain and cultures and tissues samples".

  Patient problems: Bone Fracture(s); Medical device site infection

  MAUDE report 50176953 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  As reported: "Infection Elbow Prosthesis total Elbow Arthroplasty initial - Irrigation and debridement periprosthetic infection right elbow with removal of ulnar implant and insertion of antibiotic impregnated methylmethacrylate cement beads (Tobramycin, Vancomycin, and Ancef). The tentative plan will be to treat the patient with 6 weeks of antibiotics intravenously and then plan staged revision."

  Patient problems: Medical device site infection

  MAUDE report 50176688 ↗
• InjuryJul 10, 2026Off-Label Use

  AS REPORTED: "THE ORIGINAL SCREW FOR THE LATITUDE CAP (DKY069) COULD NOT BE SCREWED INTO THE CORRESPONDING ORIGINAL SHAFT (ULNA, 0030231). SINCE THIS WAS A REVISION AFTER 6 YEARS, UNFORTUNATELY NO PACKAGING OR ADDITIONAL DOCUMENTATION IS AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782752 ↗
• InjuryMay 6, 2026Loss of Osseointegration

  IT WAS REPORTED THAT, A TOTAL ELBOW REPLACEMENT WAS DONE DUE TO BONE LOSS AND LOOSENING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 25099769 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT SUSTAINED A FRACTURED LEFT DISTAL HUMERUS (FOLLOWING A FALL) IN 2017. THIS FRACTURE WAS INTERNALLY FIXED WITH PLATE AND SCREWS, BUT IN 2018, THIS REPAIR FAILED, AND HE UNDERWENT A LEFT TOTAL ELBOW REPLACEMENT ON (B)(6) 2018. THIS PROSTHETIC JOINT HAS PERFORMED WELL, UP UNTIL ABOUT 6 MONTHS AGO, WHEN HE PRESENTED IT TO HIS SURGEON, WITH INCREASING PAIN, AND DECREASED RANGE OF MOTION. SURGEON STATED THAT THERE WERE NO CLINICAL INDICATORS SUGGESTING INFECTION. DURING SURGERY, SIGNIFICANT SYNOVITIS AND DARK COLOURED TISSUE MATERIAL WAS PRESENT IN THE PROSTHETIC JOINT - SURGEON CALLED THIS TISSUE METALOSIS. NO EVIDENCE OF ANY PUS, ETC. AFTER MULTIPLE TISSUE SAMPLES TAKEN, EXTENSIVE DEBRIDEMENT AND LAVAGE, THE SURGEON DECIDED TO REMOVE ALL IMPLANTS, AND INSERT AN ANTIBIOTIC CEMENT SPACER INTO BOTH HUMERAL AND ULNAR CANALS, WITH THE VIEW OF A 2ND STAGE PROCEDURE IN 2-3 MONTHS. NO OTHER INFORMATION AVAILABLE. STAGE 2 PROCEDURE TO BE BOOKED IN THE FUTURE - SURGEON TO ADVISE DATE. 2ND STAGE REVISION PERFORMED ON MONDAY (B)(6) 2025. SURGEON STATED THAT NO INFECTIVE ORGANISM WAS IDENTIFIED FROM SAMPLES TAKEN DURING THE 1ST STAGE OF THIS REVISION. SURGEON BELIE

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 23649801 ↗
• InjuryOct 30, 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 (FOR POST-TRAUMATIC ARTHRITIS) AT CAIRNS BASE HOSPITAL, ON (B)(6) 2023. SURGEON UNKNOWN. HE HAS BEEN EXPERIENCING PAIN, SWELLING, POOR RANGE OF MOVEMENT FOR MANY MONTHS, REFERRED TO PRINCESS ALEXANDRA HOSPITAL. DURING SURGERY, A DECISION MADE BY SURGEON TO REMOVE ALL IMPLANTS, AS THE JOINT WAS OBVIOUSLY INFECTED. ALL PRIMARY IMPLANTS REMOVED, WITHOUT TOO MUCH DIFFICULTY, AND AN ANTIBIOTIC SPACER INSERTED. STAGE 2 OF THE REVISION TO BE ATTENDED TO IN THE FUTURE, WHEN CLINICAL MARKERS OF INFECTION ARE NOT EVIDENT. NO FURTHER INFORMATION WAS AVAILABLE.

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

  MAUDE report 23430887 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "WELBOW STUDY SUBJECT : (B)(6). TWO YEARS POST-SURGERY, THE PATIENT DEVELOPED AN INFECTION IN THE OPERATED AREA, CHARACTERIZED BY PURULENT DISCHARGE THROUGH A CUTANEOUS FISTULA. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT (SAE) CAUSED A ¿HOSPITALIZATION GREATER THAN 24H¿. TO RESOLVE THIS EVENT, THE PATIENT WAS RE-OPERATED WITH IMPLANT EXTRACTION ON (B)(6) 2024. NO NEW IMPLANT WAS USED."

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 20451983 ↗
• InjuryOct 15, 2024Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "STUDY: WELBOW SUBJECT: (B)(6) COMPONENT LOOSENING. FEVER, PAIN, SEPTIC LEAKAGE TO THE LEFT ELBOW."

  Patient problems: Fever; Implant Pain; Inadequate Osseointegration; Sepsis

  MAUDE report 20451845 ↗
• 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) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 20143665 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT EXPERIENCED AN INFECTION THAT LED TO UNANTICIPATED REVISION SURGERY. DEBRIDEMENT/ WASH OUT OF PREVIOUS TOTAL ELBOW ELBOW REPLACEMENT DUE TO INFECTION. THE SURGEON STATED THE INFECTION HAS BEEN PRESENT FOR 12 MONTHS. NO EXACT DATES BEYOND THIS ARE KNOWN. THE ULNAR CAP WAS EXPLANTED. NO ISSUE WITH IMPLANTS. REMOVED DUE TO THE REPORTED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19652777 ↗
• MalfunctionSep 24, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THERE WAS A BROKEN TAIL ON THE DKY069. AT THE TIME OF IMPLANTATION NOT FULLY SCREWED INTO IMPLANT THE IMPLANT. PATIENT SUSTAINED AN INJURY RESULTING IN BROKEN CAP. A REVISION SURGERY WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15480926 ↗
• InjuryMay 18, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO SCREW/CAP BREAKAGE 7 YEARS POST-OP.

  Patient problems: Failure of Implant

  MAUDE report 14427594 ↗
• InjuryMar 2, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD FALLEN AND EXPERIENCED PAIN. UPON X-RAY IT WAS NOTED THAT THE ULNAR LOCKING CAP HAD BROKEN AT THE HINGES AND THE LOCKING SCREW HAD SHEARED OFF AT THE HEAD. THE PATIENT HAD TO UNDERGO REVISION SURGERY TO REMOVE BROKEN COMPONENTS AND GET NEW COMPONENT DEVICES.

  Patient problems: Fall; Implant Pain

  MAUDE report 13651516 ↗
• InjuryDec 21, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD TO UNDERGO A REVISION SURGERY DUE TO A FREE FLOATING SCREW FROM THE ULNAR CAP. FOLLOWING THIS SURGERY THE PATIENT HAD TO UNDERGO ANOTHER REVISION DUE TO STAPHYLOCOCCUS EPIDERMIDIS. THE INITIAL PLAN WAS TO SWAP THE SPOOL AND CAP, HOWEVER THE INFECTION LOOSENED THE HUMERAL AND ULNAR COMPONENTS. COMPONENTS WERE REMOVED AND AN ANTIBIOTIC CEMENT SPACER WAS PLACED INSITU. THE PATIENT WILL BE NEED A SUBSEQUENT OPERATION AFTER INFECTION CLEARS TO HAVE NEW COMPONENTS IMPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 13057007 ↗
• InjuryDec 6, 2021Break; Break

  A PATIENT HAD A TOTAL ELBOW REPLACEMENT USING THE LATITUDE EV SYSTEM ON THE (B)(6) 2021 AND WAS REVISED ON THE (B)(6) 2021 DUE TO THE SCREW PREVENTING BACK OUT TAB ON THE ULNAR CAP DKY069 BREAKING AND THE SCREW BACKING OUT COMPLETELY INTO THE JOINT. THE SURGEON SAYS THE PATIENT WAS DOING EXTREMELY WELL WITH THE ELBOW AND WAS ONLY WHEN THEY GOT AN XRAY HE REALISED WHAT HAD HAPPENED. THE REVISION OPERATION INVOLVED REMOVING THE BROKEN ULNAR CAP, BROKEN BACK OUT TAB (IN SOFT TISSUE) AND SCREW (ALSO IN SOFT TISSUE). AND REPLACING IT WITH ANOTHER SIZE SPECIFIC CAP DKY069. NOTHING WAS NOTED IN THE INITIAL SURGERY AS BEING UNUSUAL AND THE SURGEON HAS BEEN IMPLANTING LATITUDES/ LATITUDE EV'S FOR ABOUT 15 YEARS.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 12939739 ↗