Latitude™ - Elbow DKY217Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832011179), received between Oct 17, 2023 and Aug 7, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 50176958 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6) - WELBOW CLINICAL STUDY. POST-OPERATIVE COMPLICATION: ¿FRACTURE OF ANY PART OF THE OPERATED ARM¿ FIVE YEARS AFTER THE INITIAL SURGERY INVOLVING THE LATITUDE EV IMPLANT, THE PATIENT PRESENTED TO THEIR LOCAL GENERAL PRACTITIONER WITH PAIN AND SWELLING IN THE RIGHT ELBOW. AN X-RAY CONFIRMED THE PRESENCE OF A PERIPROSTHETIC FRACTURE. THE OUTCOME WAS REPORTED AS ¿ONGOING¿. A BACK SLAB WAS APPLIED FOR IMMOBILIZATION, AND FURTHER X-RAYS WILL BE CONDUCTED TO MONITOR THE HEALING PROGRESS AND EVALUATE THE OUTCOME

  Patient problems: Bone Fracture(s); Implant Pain; Swelling/ Edema

  MAUDE report 20096476 ↗
• InjuryOct 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "POST-OPERATIVE COMPLICATIONS SURFACED EIGHT DAYS FOLLOWING THE INITIAL SURGERY INVOLVING THE LATITUDE EV IMPLANT. THE PATIENT HAD ELBOW DISLOCATION, SIGNIFYING SIGNIFICANT INSTABILITY IN THE JOINT. THE PATIENT PRESENTED AT THE A&E WITH INTERMITTENT DISLOCATIONS AND REPORTED SENSATIONS OF PINS AND NEEDLES IN THE AFFECTED AREA. THE SURGEON CONFIRMED A CAUSAL RELATIONSHIP BETWEEN THESE COMPLICATIONS AND THE IMPLANTATION SURGERY. TO ADDRESS THE ISSUES, A REVISION SURGERY WAS DEEMED NECESSARY TO REPOSITION THE ULNAR CAP. THE RE-OPERATION TOOK PLACE ON (B)(6) 2023." UPDATE ON 25 SEP 2023. THE OPERATED ELBOW WAS THE RIGHT. HAND DOMINANCE = OPERATED.

  Patient problems: Joint Dislocation; Joint Laxity; Numbness

  MAUDE report 17952447 ↗