Latitude™ EV 0030220Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00846832002665), received between May 12, 2022 and Aug 7, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 50176685 ↗
• InjuryNov 7, 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 20629479 ↗
• 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 20096481 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED: PATIENT REQUIRED ANOTHER REVISION SURGERY DUE TO INFECTION AND COMPROMISED SKIN CONDITION.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 19761381 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REMOVAL OF ULNAR IMPLANT DUE TO INFECTION".

  Patient problems: Unspecified Infection

  MAUDE report 19364765 ↗
• 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 17953300 ↗
• InjuryMay 12, 2022Osseointegration Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Osseointegration Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD A COMPONENT LOOSENING AS A POST-OPERATIVE COMPLICATION. "GRADUAL ONSET OF PAIN AND FEELING OF INSTABILITY. RADIOGRAPHIC LUCENCY AROUND ULNAR COMPONENT SEEN X-RAY.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 14373635 ↗