LATITUDE EV™ 0830823Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832072507), received between Nov 7, 2024 and Nov 26, 2025 — classified as 2 injuries.

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.

• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ELBOW JOINT REPLACEMENT.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 23654373 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "WELBOW STUDY SUBJECT : (B)(4). 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 20629716 ↗