CEMENT RESTRICTOR EBO101Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03700386922053), received between Dec 21, 2021 and Aug 7, 2026 — classified as 20 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 20 most recent of 20 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 50176954 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  CEMENT HAD LEAKED NEAR THE ELBOW, RESTRICTING PATIENT'S MOVEMENT.

  Patient problems: Loss of Range of Motion

  MAUDE report 25830550 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED STRYKER COLLABORATIVE STUDY (SCS) NAMED "A RETROSPECTIVE DATA COLLECTION FOR THE PREVENTION OF CEMENT PROGRESSION IN THE DIAPHYSIS UTILIZING THE TORNIER CEMENT RESTRICTOR DURING IMPLANT PROCEDURES" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF CEMENT RESTRICTOR. THE DATA WAS COLLECTED BETWEEN 28 NOV 2022 AND 20 JAN 2023. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: SUPERFICIAL INFECTION IN 2 CASES IT IS FOR PATIENT 2 OUT OF 2.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24773138 ↗
• 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 24733514 ↗
• InjuryNov 25, 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 23649269 ↗
• 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 23649064 ↗
• 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 23430895 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A PATIENT WAS BOOKING IN FOR A REVISION PROCEDURE DUE TO ONGOING PAIN AND STIFFNESS. DURING THE DISSECTION LOTS OF FLUID/ PUSS WAS SEEN AND THE DECISION WAS MADE TO DO A 2 STAGE PROCEDURE TO CLEAR THE INFECTION. ANOTHER REVISION PROCEDURE WILL BE NEEDED AFTER THE INFECTION HAS CLEARED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Infection

  MAUDE report 23083920 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT WAS REVISED DUE TO AN INFECTION. ALL THE IMPLANTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22668781 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT HAD PRIMARY LEFT SHOULDER REPLACEMENT ON (B)(6) 2022. THE PATIENT COMPLAINED OF PAIN, HAD ARTHROSCOPIC DEBRIDEMENT ON (B)(6) 2024, THE SPECIMENS TAKEN SHOWED INFECTED WITH C. ACNES BACTERIUM. MULTIPLE ARTHROSCOPIC WASHOUTS / DEBRIDEMENT PROCEDURES, WITH INSERTION OF ANTIBIOTIC BEADS INTO JOINT SPACE AND LONG TERM ANTIBIOTIC THERAPY, WITH LAST PROCEDURE ON (B)(6) 2025. FURTHER SPECIMENS TAKEN DURING THIS PROCEDURE SHOWED PERSISTENT C. ACNES INFECTION, THOUGH SCANT. DURING THIS PROCEDURE, THE SURGEON MADE THE INTRA-OPERATIVE DECISION, TO REMOVE ALL PRIMARY IMPLANTS AND INSERT A ANTIBIOTIC SPACER, & CONTINUE ANTIBIOTIC (IV AND ORAL) THERAPY, AND HAVE A 2ND STAGE JOINT REPLACEMENT PROCEDURE IN THE FOLLOWING MONTHS, WHEN ALL CLINICAL MARKERS INDICATE THE INFECTION IS ABSENT. ADDITIONAL INFORMATION OF THE 2ND STAGE REVISION, WHERE THE ANTIBIOTIC CEMENT SPACER (INSITU FOR APPROX 6 WEEKS) WAS REMOVED. CLINICAL MARKERS INDICATIVE THAT THE CHRONIC INFECTION AHS RESOLVED, ACCORDING TO THE SURGEON. THOROUGH DEBRIDEMENT / LAVAGE ATTENDED TO; MULTIPLE SPECIMENS TAKEN. FULL SET OF REVISION PROSTHESIS (REVERSE SHOULDER REPLACEMENT) IMPLANTED. CEMENT USED FOR THE F

  Patient problems: Bacterial Infection

  MAUDE report 22518757 ↗
• 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) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO LYSIS AND ASEPTIC LOOSENING IN THE ULNAR AND RADIAL HEAD, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 20150221 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: 001-003 - 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 20096490 ↗
• 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 19502417 ↗
• InjuryMay 31, 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) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19434625 ↗
• InjuryMar 27, 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) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 18987431 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18903041 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED HEIGHTENED PAIN DURING MAXIMUM FLEXION, COUPLED WITH 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 WAS ORDERED TO ASSESS THE SITUATION FURTHER. THE SURGEON NOTED THAT THE INFECTION IS NOT DIRECTLY LINKED TO THE IMPLANT BUT IS RELATED TO THE INITIAL SURGERY.

  Patient problems: Implant Pain; Inflammation; Unspecified Infection

  MAUDE report 18440284 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A SHOULDER REPLACEMENT. THE PATIENT REPORTED OOZING OF THE WOUND POST-PROCEDURE. AN EXPLORATION SURGERY AND CULTURE REVEALED THE PRESENCE OF AN INFECTION. THE FIRST STAGE OF THE REVISION WAS COMPLETED WITH A WASH OUT.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 15815276 ↗
• InjuryJul 18, 2022Adverse 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 DUE TO AN INFECTION 12 MONTHS POST-OP. THE METAL DEVICES WERE REMOVED AND A COMPETITOR'S CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 15044272 ↗
• 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 13057008 ↗