Latitude™ - Elbow DKY068Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00846832010912), received between Jul 12, 2018 and Sep 24, 2026 — classified as 17 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ELBOW JOINT REPLACEMENT.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 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ELBOW JOINT REPLACEMENT.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 23654368 ↗
• 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. AS NO FURTHER INFORMATION COULD BE OBTAINED, THE REVISION SURGERY HAS BEEN CAPTURED AS IT WAS PLANNED.

  Patient problems: Insufficient Information

  MAUDE report 23316702 ↗
• InjuryOct 10, 2025Osseointegration 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 23265540 ↗
• InjuryOct 16, 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 ELBOW SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN JUNE 2018 ¿ JULY 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY; BREAKAGE, DISSOCIATION OF PROSTHESIS, RADIAL HEAD, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 20460666 ↗
• 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) 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 20143555 ↗
• InjurySep 4, 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) 2016 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 20134275 ↗
• 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 19997080 ↗
• 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 19996791 ↗
• 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 19620116 ↗
• 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 19521898 ↗
• InjuryJun 11, 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 19508507 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION SURGERY WAS PERFORMED AT (B)(6) HOSPITAL BY (B)(6). DURING THE SURGERY, THE ULNAR STEM (LATITUDE EV) WAS DISCOVERED TO BE LOOSE, WITH EVIDENCE OF POLY WEAR ON THE ULNAR COMPONENT. THE SURGEON ATTRIBUTED THIS TO EXCESSIVE MECHANICAL LOADING, LIKELY DUE TO THE PATIENT'S WEIGHT. CONSEQUENTLY, THE LOOSE COMPONENTS WERE REMOVED AND REPLACED. THE ULNAR STEM, SCREW, TAB, AND ULNAR CAP WERE BAGGED AND RETURNED TO STRYKER (B)(4). AN ADDITIONAL UPDATE STATED THAT THE ORIGINAL PLAN WAS TO REPLACE ONLY THE POLY BUSHING AND ULNAR CAP, WHICH WOULD HAVE EXTENDED THE SURGERY TIME BY APPROXIMATELY 30 MINUTES.

  Patient problems: Joint Dislocation

  MAUDE report 18822578 ↗
• 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 18610601 ↗
• InjuryAug 8, 2022Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  THE SCREW FROM THE FROM THE ULNA CAP HAS COME OUT FROM A LATITUDE EV ULNAR IMPLANT AFTER 5-6 YEARS.

  Patient problems: Failure of Implant

  MAUDE report 15184048 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE LITERATURE (HOHMAN, DONALD ET AL. 2014), THERE WERE 5 COMPLICATIONS IN 5 PATIENTS IMPLANTED WITH THE LATITUDE PROTHESIS. ONE PATIENT SUSTAINED AN INTRAOPERATIVE FRACTURE OF THE HUMERAL DIAPHYSIS, WHICH UNDERWENT REDUCTION WITH FIXATION AT THE TIME OF SURGERY, AND HEALED UNEVENTFULLY WITH NO APPARENT EFFECT ON OUTCOME. FOUR PATIENTS REQUIRED 1 OR MORE SUBSEQUENT SURGICAL PROCEDURES; HOWEVER, THERE WERE NO COMPONENT REVISIONS OR CONVERSIONS TO TOTAL ELBOW ARTHROPLASTY. THREE PATIENTS REQUIRED REMOVAL OF PROMINENT SUPPLEMENTARY INSTRUMENTATION USED FOR FIXATION, ONE OF WHICH WAS FOR KIRSCHNER WIRES, ONE FOR THE SUPPLEMENTARY SUTURE BUTTON DEVICE, AND ONE FROM THE OLECRANON OSTEOTOMY FIXATION. IN THE FOURTH PATIENT, A POSTOPERATIVE ULNAR NEUROPATHY DEVELOPED AND ULNAR NERVE TRANSPOSITION WAS REQUIRED 8 MONTHS POSTOPERATIVELY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Bone Fracture(s); Neuropathy

  MAUDE report 7703035 ↗
• MalfunctionJul 12, 2018Misconnection; Misconnection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTENDED SURGICAL TIME DUE TO THE PLACEMENT OF THE SCREW THAT "DOES NOT CATCH THE THREAD" AND SPREADS THE CAP OF THE ULNAR STEM. IT TOOK SOME EXTENDED TIME FOR THE SURGEON TO BE ABLE TO GET THE SCREW TO CATCH APPROPRIATELY. THE ISSUE CAUSE EXTENDED OPERATING TIME, THEREFORE TOURNIQUET TIME AND ANESTHESIA TIME.

  Patient problems: No Code Available

  MAUDE report 7682823 ↗