Latitude™ EV 0030503Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832002863), received between Dec 21, 2021 and Sep 28, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Inadequate Osseointegration; Post Operative Wound Infection

  MAUDE report 50918144 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT SUSTAINED A FRACTURED LEFT DISTAL HUMERUS (FOLLOWING A FALL) IN 2017. THIS FRACTURE WAS INTERNALLY FIXED WITH PLATE AND SCREWS, BUT IN 2018, THIS REPAIR FAILED, AND HE UNDERWENT A LEFT TOTAL ELBOW REPLACEMENT ON (B)(6) 2018. THIS PROSTHETIC JOINT HAS PERFORMED WELL, UP UNTIL ABOUT 6 MONTHS AGO, WHEN HE PRESENTED IT TO HIS SURGEON, WITH INCREASING PAIN, AND DECREASED RANGE OF MOTION. SURGEON STATED THAT THERE WERE NO CLINICAL INDICATORS SUGGESTING INFECTION. DURING SURGERY, SIGNIFICANT SYNOVITIS AND DARK COLOURED TISSUE MATERIAL WAS PRESENT IN THE PROSTHETIC JOINT - SURGEON CALLED THIS TISSUE METALOSIS. NO EVIDENCE OF ANY PUS, ETC. AFTER MULTIPLE TISSUE SAMPLES TAKEN, EXTENSIVE DEBRIDEMENT AND LAVAGE, THE SURGEON DECIDED TO REMOVE ALL IMPLANTS, AND INSERT AN ANTIBIOTIC CEMENT SPACER INTO BOTH HUMERAL AND ULNAR CANALS, WITH THE VIEW OF A 2ND STAGE PROCEDURE IN 2-3 MONTHS. NO OTHER INFORMATION AVAILABLE. STAGE 2 PROCEDURE TO BE BOOKED IN THE FUTURE - SURGEON TO ADVISE DATE. 2ND STAGE REVISION PERFORMED ON MONDAY (B)(6) 2025. SURGEON STATED THAT NO INFECTIVE ORGANISM WAS IDENTIFIED FROM SAMPLES TAKEN DURING THE 1ST STAGE OF THIS REVISION. SURGEON BELIE

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 23649069 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT LEFT TOTAL ELBOW REPLACEMENT (FOR POST-TRAUMATIC ARTHRITIS) AT CAIRNS BASE HOSPITAL, ON (B)(6) 2023. SURGEON UNKNOWN. HE HAS BEEN EXPERIENCING PAIN, SWELLING, POOR RANGE OF MOVEMENT FOR MANY MONTHS, REFERRED TO PRINCESS ALEXANDRA HOSPITAL. DURING SURGERY, A DECISION MADE BY SURGEON TO REMOVE ALL IMPLANTS, AS THE JOINT WAS OBVIOUSLY INFECTED. ALL PRIMARY IMPLANTS REMOVED, WITHOUT TOO MUCH DIFFICULTY, AND AN ANTIBIOTIC SPACER INSERTED. STAGE 2 OF THE REVISION TO BE ATTENDED TO IN THE FUTURE, WHEN CLINICAL MARKERS OF INFECTION ARE NOT EVIDENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23430891 ↗
• InjuryDec 21, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD TO UNDERGO A REVISION SURGERY DUE TO A FREE FLOATING SCREW FROM THE ULNAR CAP. FOLLOWING THIS SURGERY THE PATIENT HAD TO UNDERGO ANOTHER REVISION DUE TO STAPHYLOCOCCUS EPIDERMIDIS. THE INITIAL PLAN WAS TO SWAP THE SPOOL AND CAP, HOWEVER THE INFECTION LOOSENED THE HUMERAL AND ULNAR COMPONENTS. COMPONENTS WERE REMOVED AND AN ANTIBIOTIC CEMENT SPACER WAS PLACED INSITU. THE PATIENT WILL BE NEED A SUBSEQUENT OPERATION AFTER INFECTION CLEARS TO HAVE NEW COMPONENTS IMPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 13056876 ↗