CEMENT RESTRICTOR EBO102Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03700386928710), received between Dec 21, 2021 and Aug 7, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 50176955 ↗
• 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 8TH DEC 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 23649065 ↗
• 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 23430893 ↗
• InjuryOct 15, 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 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) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20449255 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6) - WELBOW CLINICAL STUDY. POST-OPERATIVE COMPLICATION: ¿FRACTURE OF ANY PART OF THE OPERATED ARM¿ FIVE YEARS AFTER THE INITIAL SURGERY INVOLVING THE LATITUDE EV IMPLANT, THE PATIENT PRESENTED TO THEIR LOCAL GENERAL PRACTITIONER WITH PAIN AND SWELLING IN THE RIGHT ELBOW. AN X-RAY CONFIRMED THE PRESENCE OF A PERIPROSTHETIC FRACTURE. THE OUTCOME WAS REPORTED AS ¿ONGOING¿. A BACK SLAB WAS APPLIED FOR IMMOBILIZATION, AND FURTHER X-RAYS WILL BE CONDUCTED TO MONITOR THE HEALING PROGRESS AND EVALUATE THE OUTCOME.

  Patient problems: Bone Fracture(s); Implant Pain; Swelling/ Edema

  MAUDE report 20096504 ↗
• 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: Discomfort; Implant Pain; Insufficient Information; Loss of Range of Motion

  MAUDE report 19500228 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT REPORTED HEIGHTENED PAIN DURING MAXIMUM FLEXION, ALONGSIDE SLIGHTLY ELEVATED INFLAMMATORY MARKERS. A CT SCAN REVEALED INDICATIONS OF INFECTION AROUND THE TIP OF THE ULNAR PROSTHESIS. FOLLOWING CLINICAL FEEDBACK, A SPECT CT SCAN HAS BEEN ORDERED TO DEFINE REQUIRED ACTIONS. THE SURGEON SUGGESTED THAT THE INFECTION IS NOT DIRECTLY LINKED TO THE IMPLANT BUT HAS A CASUAL RELATIONSHIP WITH THE INITIAL SURGERY.

  Patient problems: Implant Pain; Inflammation; Unspecified Infection

  MAUDE report 18449987 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TO UNDERGO A REVISION SURGERY DUE TO A FREE FLOATING SCREW FROM THE ULNAR CAP. FOLLOWING THIS SURGERY THE PATIENT HAD TO UNDERGO ANOTHER REVISION DUE TO STAPHYLOCOCCUS EPIDERMIDIS. THE INITIAL PLAN WAS TO SWAP THE SPOOL AND CAP, HOWEVER THE INFECTION LOOSENED THE HUMERAL AND ULNAR COMPONENTS. COMPONENTS WERE REMOVED AND AN ANTIBIOTIC CEMENT SPACER WAS PLACED INSITU. THE PATIENT WILL BE NEED A SUBSEQUENT OPERATION AFTER INFECTION CLEARS TO HAVE NEW COMPONENTS IMPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 13057013 ↗