Latitude™ - Elbow DKY213Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00846832011131), received between Jan 5, 2024 and Sep 5, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2024Break; Fracture; Unstable; Break; Fracture; Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY AND BREAKAGE/DISSOCIATION OF THE PROSTHESIS RADIAL HEAD, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 20150126 ↗
• InjurySep 5, 2024Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s)

  MAUDE report 20148014 ↗
• InjurySep 5, 2024Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s)

  MAUDE report 20143725 ↗
• InjurySep 5, 2024Osseointegration Problem; Osseointegration Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE AND ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 20143568 ↗
• InjurySep 5, 2024Osseointegration Problem; Osseointegration Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 20143417 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED: THE PATIENT UNDERWENT RIGHT ELBOW REPLACEMENT ON (B)(6) 2020. THE PRIMARY IMPLANTS IN THE JOINT BECAME INFECTED, AND A REVISION SURGERY WAS PERFORMED APPROXIMATELY 3 MONTHS LATER, WHERE SEVERAL COMPONENTS WERE EXCHANGED, DEBRIDEMENT / SPECIMENS COLLECTED / LAVAGE. ACCORDING TO THE SURGEON, THE PATIENT HAS UNDERGONE SEVERAL WASHOUTS / DEBRIDEMENT PROCEDURES OF HIS RIGHT ELBOW JOINT, SINCE. THE PATIENT HAS SIGNIFICANT CO-MORBIDITIES, WHICH HAS PREVENTED MORE SUBSTANTIAL SURGERY. HOWEVER, THE PATIENT HAS BEEN EXPERIENCING SIGNIFICANT PAIN OVER RECENT MONTHS. ADDITIONALLY, IT WAS REPORTED THERE WAS A LOOSE ULNAR COMPONENT. DECISION MADE TO EXCHANGE THIS COMPONENT, INCLUDING HUMERAL SPOOL. PRIMARY ULNAR COMPONENT REMOVED (VERY EASILY), CANAL DEBRIDED, MULTIPLE SPECIMENS TAKEN, COPIOUS LAVAGE PERFORMED, AND A LONGER ULNAR STEM CEMENTED IN PLACE.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 19997142 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED: THE PATIENT UNDERWENT RIGHT ELBOW REPLACEMENT ON (B)(6) 2020. THE PRIMARY IMPLANTS IN THE JOINT BECAME INFECTED, AND A REVISION SURGERY WAS PERFORMED APPROXIMATELY 3 MONTHS LATER, WHERE SEVERAL COMPONENTS WERE EXCHANGED, DEBRIDEMENT / SPECIMENS COLLECTED / LAVAGE. ACCORDING TO THE SURGEON, THE PATIENT HAS UNDERGONE SEVERAL WASHOUTS / DEBRIDEMENT PROCEDURES OF HIS RIGHT ELBOW JOINT, SINCE. THE PATIENT HAS SIGNIFICANT CO-MORBIDITIES, WHICH HAS PREVENTED MORE SUBSTANTIAL SURGERY. HOWEVER, THE PATIENT HAS BEEN EXPERIENCING SIGNIFICANT PAIN OVER RECENT MONTHS. ADDITIONALLY, IT WAS REPORTED THERE WAS A LOOSE ULNAR COMPONENT. DECISION MADE TO EXCHANGE THIS COMPONENT, INCLUDING HUMERAL SPOOL. PRIMARY ULNAR COMPONENT REMOVED (VERY EASILY), CANAL DEBRIDED, MULTIPLE SPECIMENS TAKEN, COPIOUS LAVAGE PERFORMED, AND A LONGER ULNAR STEM CEMENTED IN PLACE.

  Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 19996787 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: PRIMARY RIGHT ELBOW REPLACEMENT BY SURGEON, ON (B)(6) 2023. PATIENT COMPLAINED THAT THE SURGERY "DIDN'T FEEL QUITE RIGHT" FROM EARLY POST-OP. SURGEON REVISED PROSTHETIC JOINT ON (B)(6) 2023 SUSPECTING INFECTION, THOUGH NO ORGANISM CULTURED. FOR MOST OF LAST 12 MONTHS, PATIENT GENERALLY HAPPY WITH PROSTHETIC JOINT, BUT COMPLAINED TO SURGEON OVER RECENT MONTHS, THAT THIS ELBOW JOINT WAS CAUSING HIM MORE DISCOMFORT AND STIFFNESS. SURGEON DECIDED TO REVISE THE PROSTHETIC JOINT AGAIN. ALL PROSTHESIS REMOVED, AND DISCARDED. SPECIMENS TAKEN FOR PATHOLOGY. ALL ORIGINAL BONE CEMENT REMOVED. COPIOUS LAVAGE ATTENDED. ALL JOINT AND MEDULLARY CANAL SURFACES IRRIGATED WITH AQUEOUS BETADINE. FULL SET OF PROSTHESIS CEMENTED IN, WITH ANTIBIOTIC CEMENT". THIS RECORD COVERS THE SECOND REVISION SURGERY.

  Patient problems: Discomfort; Loss of Range of Motion

  MAUDE report 19521881 ↗
• 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 19500211 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "WELBOW SUBJECT (B)(6). 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 18610599 ↗
• InjuryJan 5, 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 18455882 ↗