LATITUDE EV™ 0030720Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832074808), received between Oct 17, 2023 and Oct 15, 2024 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 20451934 ↗
• 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 (B)(6) 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 (B)(6) 2023 THE OPERATED ELBOW WAS THE RIGHT. HAND DOMINANCE = OPERATED.

  Patient problems: Joint Dislocation; Joint Laxity; Numbness

  MAUDE report 17951592 ↗