Latitude™ EV 0030120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832002573), received between Dec 18, 2023 and Jun 10, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY AFTER A SUSPECTED INFECTION. THE CULTURE CAME BACK NEGATIVE FOR INFECTION.

  Patient problems: Inadequate Pain Relief; Insufficient Information

  MAUDE report 19500224 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "(B)(4). ONE-MONTH POST-SURGERY INVOLVING THE TOTAL LATITUDE IMPLANT, THE PATIENT EXPERIENCED PERSISTENT AND ABNORMAL PAIN, ACCOMPANIED BY HEIGHTENED STIFFNESS. NOTABLY, THERE IS A MARKED REDUCTION IN THE PATIENT'S RANGE OF MOTION, WITH INCREASED VIGILANCE REQUIRED DUE TO THE EMERGENCE OF AGGRESSIVE MUSCLE CONTRACTIONS IN THE BRACHIO-RADIAL MUSCLE. FURTHERMORE, THERE IS A PRONOUNCED RIGIDITY OBSERVED DURING FLEXION, EMPHASIZING THE NEED FOR CLOSE MONITORING AND PROMPT INTERVENTION. TO ADDRESS THIS ISSUE EFFECTIVELY, A COMPREHENSIVE REHABILITATION PROGRAM FEATURING GENTLE KINETHERAPY AND TARGETED MUSCLE MASSAGE WERE PRESCRIBED. ADDITIONALLY, A PROCEDURE INVOLVING THE REMOVAL OF THE SPLINT AT A 90° FLEXION ANGLE WAS CARRIED OUT TO AUGMENT THE OVERALL TREATMENT STRATEGY. THIS EVENT WAS RESOLVED WITHOUT SEQUELAE."

  Patient problems: Cramp(s) /Muscle Spasm(s); Implant Pain; Loss of Range of Motion

  MAUDE report 18610604 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED HEIGHTENED PAIN DURING MAXIMUM FLEXION, ACCOMPANIED BY SLIGHTLY ELEVATED INFLAMMATORY MARKERS. A CT SCAN REVEALED SIGNS OF INFECTION AROUND THE TIP OF THE ULNAR PROSTHESIS. FOLLOWING A CONSULTATION, A SPECT CT SCAN WAS ORDERED FOR FURTHER ASSESSMENT. THE SURGEON INDICATED THAT THE INFECTION IS NOT DIRECTLY LINKED TO THE IMPLANT BUT IS ASSOCIATED WITH THE INITIAL SURGERY.

  Patient problems: Implant Pain; Inflammation; Unspecified Infection

  MAUDE report 18475502 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL STUDY THAT THERE WAS INTRAOPERATIVE COMPLICATION THAT OCCURRED DURING THE SURGERY. PROBABLE SMALL CORTICAL PERFORATION LEADING TO CEMENT LEAKAGE WHILE PLACING ULNAR COMPONENT. THIS EVENT WAS REPORTED WITH A CAUSAL RELATIONSHIP TO THE SURGICAL PROCEDURE. NO ACTIONS WERE NEEDED TO ADDRESS THE ISSUES BECAUSE CEMENT CAUSING NO SYMPTOM SO NOT REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 18351892 ↗