Latitude EVRecalls & reported problems across all models

We found 24 models of Latitude EV by Tornier, Inc. in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Nov 3, 2021 and Sep 28, 2026 — classified as 56 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Latitude EV problems

Latitude EV models

24 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Latitude™ EV 0030220

  PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
  7 reports
• Latitude™ EV 0030121

  PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
  5 reports
• Latitude™ EV 0030221

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  5 reports
• Latitude™ EV 0030120

  PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
  4 reports
• Latitude™ EV 0030503

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  4 reports
• LATITUDE EV™ 0030711

  PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
  3 reports
• Latitude™ EV 0030020

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  2 reports
• Latitude™ EV 0030031

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  2 reports
• Latitude™ EV 0030302

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  2 reports
• Latitude™ EV 0030313

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  2 reports
• Latitude™ EV 0030402

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  2 reports
• Latitude™ EV 0030502

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  2 reports
• LATITUDE EV™ 0830819

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  2 reports
• LATITUDE EV™ 0830823

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  2 reports
• LATITUDE EV™ 0030710

  PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
  2 reports
• LATITUDE EV™ 0030720

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  2 reports
• Latitude™ EV 0030010

  PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
  1 report
• Latitude™ EV 0030030

  PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
  1 report
• Latitude™ EV 0030210

  PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
  1 report
• Latitude™ EV 0030403

  PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
  1 report
• Latitude™ EV 0030513

  PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
  1 report
• Latitude™ EV 0030523

  PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
  1 report
• LATITUDE EV™ 0830817

  PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
  1 report
• LATITUDE EV™ 0030700

  PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
  1 report

Recent Latitude EV adverse event reports

The 15 most recent reports across all models, 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 50918145 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Inadequate Osseointegration; Post Operative Wound Infection

  MAUDE report 50918144 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  As reported: "Irrigation and debridement periprosthetic infection right elbow, removal elbow implant and cement and insertion of antibiotic impregnated cement spacer and beads. During removal(Cement ) portion of the medial condyle fractured fractured off and was excised. A large spacer was made and intersected into the distal humerus in beads were made inserted into the proximal ulna into the anterior soft tissues...Joint was reduced, A medium Hemovac drain was placed in the depths of the wound and brought out proximally through ta lateral stab incision. Swabs was obtained intraop for aerobic Gram stain and cultures and tissues samples"

  Patient problems: Bone Fracture(s); Medical device site infection

  MAUDE report 50176957 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  As reported: "Infection Elbow Prosthesis total Elbow Arthroplasty initial - Irrigation and debridement periprosthetic infection right elbow with removal of ulnar implant and insertion of antibiotic impregnated methylmethacrylate cement beads (Tobramycin, Vancomycin, and Ancef). The tentative plan will be to treat the patient with 6 weeks of antibiotics intravenously and then plan staged revision."

  Patient problems: Medical device site infection

  MAUDE report 50176685 ↗
• InjuryMay 6, 2026Loss of Osseointegration

  IT WAS REPORTED THAT, A TOTAL ELBOW REPLACEMENT WAS DONE DUE TO BONE LOSS AND LOOSENING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 25099813 ↗
• InjuryApr 22, 2026Osseointegration Problem

  IT WAS REPORTED THAT; THE FIRST REVISION WAS DONE ON (b)(6) 2024. THE REVISION SURGERY WAS PERFORMED BECAUSE OF JUST LOOSENING DUE TO INFECTION, THERE WAS NO FRACTURE FOR THIS CASE. LATER, THE SECOND REVISION WAS DONE. IT WAS REPORTED THAT, THE ULNAR STEM REMAINED INTACT SINCE FIRST SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 24960472 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A REMOVAL OF LATITUDE EV TOTAL ELBOW REPLACEMENT WAS PERFORMED FOR A PATIENT WHO HAD AN INFECTION. THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2025. THE SURGEON ACCESSED THE JOINT AND REMOVED A SIGNIFICANT AMOUNT OF BLACK MATTER AND THEN PROCEEDED TO TAKE THE HUMERAL AND ULNAR STEM OUT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 24736415 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A REMOVAL OF LATITUDE EV TOTAL ELBOW REPLACEMENT WAS PERFORMED FOR A PATIENT WHO HAD AN INFECTION. THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2025. THE SURGEON ACCESSED THE JOINT AND REMOVED A SIGNIFICANT AMOUNT OF BLACK MATTER AND THEN PROCEEDED TO TAKE THE HUMERAL AND ULNAR STEM OUT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 24732933 ↗
• 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 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 23654370 ↗
• 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 23654366 ↗
• 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 ↗
• 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 ↗
• 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 23649066 ↗
• 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 (B)(6) HOSPITAL, ON (B)(6) 2023. SURGEON UNKNOWN. HE HAS BEEN EXPERIENCING PAIN, SWELLING, POOR RANGE OF MOVEMENT FOR MANY MONTHS, REFERRED TO (B)(6) 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 23430902 ↗

Other Tornier, Inc. products

• Tornier Perform Reversed Glenoid41 models · 515 reports · 1 recall
• Tornier Perform40 models · 290 reports · 1 recall
• TORNIER PERFORM HUMERAL SYSTEM68 models · 190 reports · 1 recall
• Tornier HRS40 models · 176 reports · 1 recall
• Tornier Perform Reversed Augmented Glenoid8 models · 121 reports · 1 recall
• AEQUALIS FLEX REVIVE24 models · 70 reports · 2 recalls
• Latitude - Elbow35 models · 147 reports
• Tornier Latitude7 models · 14 reports · 1 recall