Latitude - ElbowRecalls & reported problems across all models
Tornier, Inc. · 35 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 147
- Deaths reported
- 0
- Injuries reported
- 142
- Recalls
- 0
We found 35 models of Latitude - Elbow by Tornier, Inc. in the FDA's device registry (GUDID). Together they are named in 147 adverse event reports in the FDA's MAUDE database, received between Jul 12, 2018 and Sep 28, 2026 — classified as 142 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Osseointegration Problem” (36 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
Reports received per month, all models
Most reported Latitude - Elbow problems
Device problems
- Adverse Event Without Identified Device or Use Problem78
- Osseointegration Problem36
- Unstable15
- Fracture14
- Break13
- Device Dislodged or Dislocated4
- Loosening of Implant Not Related to Bone-Ingrowth4
- Loss of Osseointegration4
Patient problems
- Unspecified Infection41
- Inadequate Osseointegration37
- Bone Fracture(s)30
- Implant Pain21
- Joint Laxity20
- Loss of Range of Motion13
- Failure of Implant12
- Osteolysis8
Latitude - Elbow models
35 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Latitude™ - Elbow DKY068PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED20 reports
- Latitude™ - Elbow DKY069PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED16 reports
- Latitude™ - Elbow DKY213PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED11 reports
- Latitude™ - Elbow DKY057PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED10 reports
- Latitude™ - Elbow DKY061PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED9 reports
- Latitude™ - Elbow DKY067PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED8 reports
- Latitude™ - Elbow DKY062PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED7 reports
- Latitude™ - Elbow DKY211PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED5 reports
- Latitude™ - Elbow DKY214PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED5 reports
- Latitude™ - Elbow DKY216PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
- Latitude™ - Elbow DKY082PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
- Latitude™ - Elbow DKY212PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED4 reports
- Latitude™ - Elbow DKY183PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED4 reports
- Latitude™ - Elbow DKY056PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED3 reports
- Latitude™ - Elbow DKY058PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED3 reports
- Latitude™ - Elbow DKY215PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED3 reports
- Latitude™ - Elbow DKY217PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED3 reports
- Latitude™ - Elbow DKY218PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED3 reports
- Latitude™ - Elbow DKY121PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- Latitude™ - Elbow DKY085PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- Latitude™ - Elbow DKY182PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- Latitude™ - Elbow DKY184PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- Latitude™ - Elbow DKY185PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- Latitude™ - Elbow DKY192PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- Latitude™ - Elbow DKY059PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Latitude™ - Elbow DKY120PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Latitude™ - Elbow DKY122PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Latitude™ - Elbow DKY223PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED1 report
- Latitude™ - Elbow DKY071PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Latitude™ - Elbow DKY072PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED1 report
- Latitude™ - Elbow DKY081PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Latitude™ - Elbow DKY083PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Latitude™ - Elbow DKY086PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED1 report
- Latitude™ - Elbow DKY181PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Latitude™ - Elbow DKY191PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED1 report
Recent Latitude - Elbow 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 50918121 ↗MalfunctionSep 24, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892154 ↗MalfunctionSep 24, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892153 ↗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 50176958 ↗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 50176953 ↗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 50176688 ↗InjuryJul 10, 2026Off-Label Use
AS REPORTED: "THE ORIGINAL SCREW FOR THE LATITUDE CAP (DKY069) COULD NOT BE SCREWED INTO THE CORRESPONDING ORIGINAL SHAFT (ULNA, 0030231). SINCE THIS WAS A REVISION AFTER 6 YEARS, UNFORTUNATELY NO PACKAGING OR ADDITIONAL DOCUMENTATION IS AVAILABLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25782752 ↗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 25099815 ↗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 25099769 ↗InjuryApr 23, 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. ULNAR STEM REMAINED IN TACT SINCE FIRST SURGERY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24967206 ↗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 24734944 ↗InjuryMar 10, 2026Adverse 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) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 24558919 ↗InjuryMar 10, 2026Adverse 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) 2026.DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (b)(6) 2025, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 24558917 ↗InjuryDec 23, 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 ON (B)(6) 2025, FOLLOWING A FALL (SUSTAINED A FRACTURED LEFT DISTAL HUMERUS). PATIENT PRESENTED APPROXIMATELY 2 X WEEKS AGO TO HOSPITAL WITH PAIN, INCREASED SWELLING, REDNESS IN LEFT ELBOW JOINT: MALAISE. COMMENCED ON ANTIBIOTICS. NO IMPROVEMENT. DECISION MADE TO OPEN WOUND AND IRRIGATE SUSPECTED PROSTHETIC ELBOW JOINT INFECTION. DURING SURGERY, A LARGE COLLECTION OF PUS WAS DRAINED FROM THE LEFT ELBOW - APPROX 2 LITRES. MULTIPLE SAMPLES / SPECIMENS TAKEN. WOUND DEBRIDED. COPIOUS LAVAGE. SURGEON DECIDED TO EXCHANGE THE ULNAR CAP IMPLANT, PLUS THE HUMERAL SPOOL AND LOCKING SCREW. THESE WERE REPLACED WITHOUT DIFFICULTY. WOUND CLOSED.
Patient problems: Unspecified Infection
MAUDE report 23877744 ↗InjuryDec 23, 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 ON (B)(6) 2025, FOLLOWING A FALL (SUSTAINED A FRACTURED LEFT DISTAL HUMERUS). PATIENT PRESENTED APPROXIMATELY 2 X WEEKS AGO TO HOSPITAL WITH PAIN, INCREASED SWELLING, REDNESS IN LEFT ELBOW JOINT: MALAISE. COMMENCED ON ANTIBIOTICS. NO IMPROVEMENT. DECISION MADE TO OPEN WOUND AND IRRIGATE SUSPECTED PROSTHETIC ELBOW JOINT INFECTION. DURING SURGERY, A LARGE COLLECTION OF PUS WAS DRAINED FROM THE LEFT ELBOW - APPROX 2 LITRES. MULTIPLE SAMPLES / SPECIMENS TAKEN. WOUND DEBRIDED. COPIOUS LAVAGE. SURGEON DECIDED TO EXCHANGE THE ULNAR CAP IMPLANT, PLUS THE HUMERAL SPOOL AND LOCKING SCREW. THESE WERE REPLACED WITHOUT DIFFICULTY. WOUND CLOSED.
Patient problems: Unspecified Infection
MAUDE report 23877741 ↗
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
- Tornier Latitude7 models · 14 reports · 1 recall
- Latitude EV24 models · 56 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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