INFINITY 33654307Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00840420122742), received between Apr 13, 2023 and Nov 19, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT REQUIRED A REVISION SURGERY BECAUSE OF A STAGED REVISION APPROACH, REQUIRING THE IMPLANTING A CEMENT SPACER DUE TO PERITIBIAL CYSTIC LOOSENING WITH INFECTION. THE TIBIAL COMPONENT DEMONSTRATED LOOSENING. WITH THE TALAR COMPONENTS THE MORSE TAPER BETWEEN THE TALAR DOME AND THE TALAR STEM HAD NOT BEEN PROPERLY ENGAGED AND INSPECTION AFTER REMOVAL OF THE TALAR STEM REVEALED DELAMINATION OF THE PLASMA COATING.

  Patient problems: Inadequate Osseointegration; Medical device site infection

  MAUDE report 23596191 ↗
• InjuryNov 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY. THE PRIMARY IMPLANT CONSISTED OF A TIBIAL TRAY AND TALAR DOME. THE PATIENT LATER REQUIRED REMOVAL OF THE IMPLANT AND PLACEMENT OF AN ANTIBIOTIC CEMENT SPACER DUE TO SUSPECTED INFECTION, ALONG WITH NOTED POOR BONE QUALITY AND A LARGE BONE CYST SUPERIOR TO THE TIBIAL TRAY.

  Patient problems: Arthritis; Cyst(s); Inadequate Osseointegration; Post Operative Wound Infection

  MAUDE report 23528283 ↗
• InjuryOct 20, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN 2016 TO 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Pain

  MAUDE report 23335171 ↗
• InjuryMay 21, 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 ANKLE 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 & PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE- STAGE 2 OF 2 STAGE REVISION.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 22059329 ↗
• InjuryMay 21, 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 ANKLE 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.

  Patient problems: Unspecified Infection

  MAUDE report 22059322 ↗
• InjuryMay 15, 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 ANKLE 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 - ACTIVE WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22029946 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6). UK INFINITY TOTAL ANKLE SYSTEM STUDY. (B)(6) 2024 - START UP STIFFNESS: SMALL DEGREE OF START UP STIFFNESS LASTING ONLY 10 STEPS OR SO. PREVIOUSLY NO COMPLAINTS OF STIFFNESS AT ALL FOLLOW-UP APPOINTMENTS. AT VISIT PATIENT REPORTED STIFFNESS. X-RAYS FROM VISIT ON (B)(6) 2024 SHOW DEGREE OF LICENCE AND PREVIOUSLY IDENTIFIED OSTEOCYTES BUT NO CHANGE FROM LAST X-RAYS."

  Patient problems: Loss of Range of Motion

  MAUDE report 21945047 ↗
• InjuryApr 3, 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 ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025, A PATIENT REQUIRED REVISION SURGERY DUE TO MALALIGNMENT, UNEXPLAINED PAIN AND PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s); Implant Pain; Subluxation

  MAUDE report 21760801 ↗
• InjuryDec 11, 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 OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN JANUARY 2018 ¿ DECEMBER 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO HIGH SUSPICION (E.G. PUS OR CONFIRMED MICRO), WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 20901654 ↗
• InjuryDec 4, 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 OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN JANUARY 2018 ¿ DECEMBER 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION & ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 20840948 ↗
• InjuryNov 7, 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 OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN JANUARY 2018 ¿ DECEMBER 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO HIGH SUSPICION (E.G. PUS OR CONFIRMED MICRO), WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 20634218 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT HAD WOUND INFECTION. PRESENTED AT CLINIC SIX WEEKS POST OP WITH POOR HEALING. THERE WAS A 2X1CM SECTION OF NECROTIC TISSUE. ORAL ANTIBIOTICS COMMENCED AND REFERRED TO PLASTIC TEAM. ADMITTED FOR WOUND WASHOUT AND SPLIT SKIN GRAFT. ANKLE JOINT ASPIRATION COMPLETED ON (B)(6) 2017 WITH NO GROWTH ON DIRECT CULTURE."

  Patient problems: Bacterial Infection; Necrosis

  MAUDE report 19696953 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REVISION SURGERY TO REMOVE THE IMPLANTS AND REPLACE WITH A CEMENT SPACER DUE TO INFECTION. THE PATIENT DIDN'T HAVE THE NORMAL AMOUNT OF POST-OP APPOINTMENTS DUE TO THE COVID LOCKDOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19484706 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS AN UPCOMING REVISION SURGERY. THE DOCTORS ARE PLANNING TO REVISE BOTH THE TIBIA AND TALUS FOR THE PATIENT. PATIENT CAME TO THE DOCTOR WITH PAIN IN THE ANKLE JOINT. WHILE TAKING X RAY PHOTOS THE DOCTOR CONCLUDED THAT THE IMPLANT POSITION WAS SUBPAR ON THE TIBIAL COMPONENT AND TALUS. TIBIAL COMPONENT HAS SOME SUBSIDENCE. THEY JUST SAW THIS PATIENT FOR THE FIRST TIME RECENTLY, THE ORIGINAL SURGERY WAS DONE BY ANOTHER SURGEON. THE DOCTOR HASN'T DONE ANY OTHER PROCEDURES ON THE PATIENT YET.

  Patient problems: Implant Pain

  MAUDE report 16736391 ↗