Latitude™ EV 0030121Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00846832002580), received between Mar 1, 2024 and Nov 26, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

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 5 most recent of 5 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ELBOW JOINT REPLACEMENT.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 23654363 ↗
• InjuryOct 16, 2025Unstable; Unstable

  IT WAS REPORTED THAT, THE PATIENT WOULD REQUIRE A REVISION SURGERY FOR FAILURE OF ELBOW LOCKING MECHANISM. THE PLANNED DATE OF REVISION WAS (B)(6) 2025 2025. AS NO FURTHER INFORMATION COULD BE OBTAINED, THE REVISION SURGERY HAS BEEN CAPTURED AS IT WAS PLANNED.

  Patient problems: Insufficient Information

  MAUDE report 23316758 ↗
• InjuryOct 10, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT OPEN REDUCTION, INTERNAL FIXATION OF FRACTURED LEFT DISTAL HUMERUS, IN 2017. SHE UNDERWENT TOTAL ELBOW REPLACEMENT ON (B)(6) 2017, USING TORNIER LATITUDE TER IMPLANTS. SHE HAS BEEN VERY HAPPY WITH THIS SURGERY UNTIL RECENT MONTHS BUT LATER PRESENTED WITH PAINFUL LEFT ELBOW, DECREASED RANGE OF MOTION, SWELLING. X-RAYS SUGGESTIVE OF POSSIBLE INFECTION AND LOOSENING. SURGERY FAILED DUE TO INFECTION. DURING SURGERY TODAY, GROSS AMOUNT OF SYNOVITIS TISSUE WAS FOUND, AND EXCISED. ULNAR COMPONENTS WERE FRANKLY LOOSE AND REMOVED BY THE SURGEON USING HIS FINGERS ONLY. MULTIPLE TISSUE SPECIMENS WERE TAKEN. HUMERAL COMPONENTS WERE STILL WELL FIXED, BUT WITH OSTEOLYSIS AROUND THE DISTAL PART OF THE PROSTHESIS. SURGEON DECIDED TO REMOVE THIS COMPONENT (WHICH WAS WELL FIXED), CLEAN OUT BOTH MEDULLARY CANALS, COPIOUS LAVAGE, AND IMPLANT REVISION SIZED EXTRA-LONG COMPONENTS. AS REPORTED, EXPLANTED COMPONENTS ARE AVAILABLE FOR RETURN. BOTH REVISION COMPONENTS CEMENTED IN USING ANTIBIOTIC CEMENT. JOINT STABLE ON REDUCTION AND WOUND CLOSED. SURGEON PERFORMED THIS, 1-STAGE REVISION ARTHROPLASTY BECAUSE OF MULTIPLE CO-MORBIDITIES THAT THE PATIENT SUFFERS FROM

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

  MAUDE report 23265553 ↗
• InjuryJun 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SCREW THAT CONNECTS THE LATITUDE ULNAR CAP IMPLANT TO THE LATITUDE ULNAR STEM IMPLANT DISASSOCIATED AND THEREFORE PATIENT WILL REQUIRE A REVISION SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 19620147 ↗
• InjuryMar 1, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  DURING A SURGICAL PROCEDURE, THE #5 FLEXIBLE REAMER BROKE WHILE BEING USED ON A PATIENT'S ELBOW. BOTH PIECES OF THE REAMER WERE RETRIEVED, AND AN X-RAY WAS TAKEN, WHICH SHOWED NO ABNORMALITIES. THE ORIGINAL INTENDED PROCEDURE WAS THE REMOVAL OF HARDWARE FROM THE RIGHT ELBOW, INSERTION OF A CEMENT ANTIBIOTIC SPACER, IRRIGATION AND DEBRIDEMENT OF THE RIGHT ELBOW, AND BURSECTOMY OF THE OLECRANON BURSA. THE USER ENCOUNTERED PROBLEMS RELATED TO DEVICE FAILURE AND MALFUNCTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 18822906 ↗