INBONE 220220901Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840420124203), received between Aug 30, 2022 and Oct 20, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 LYSIS IN TIBIA AND LYSIS IN TALUS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 23335189 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO PAIN IN JOINTS.

  Patient problems: Cyst(s); Inadequate Osseointegration; Pain

  MAUDE report 23301353 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, LYSIS & PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Implant Pain; Osteolysis; Unspecified Infection

  MAUDE report 20901762 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: UK INFINITY® TOTAL ANKLE SYSTEM SUBJECT: (B)(6). WORSENING CHRONIC PAIN MEDIAL ASPECT OF RIGHT ANKLE WITH DIFFICULTY MOBILIZING. IN YEAR 2 IN 2021, QUESTIONNAIRES STATED WORSENING PAIN AWAITING FURTHER DECISION RE-POTENTIAL REVISION SURGERY, POSSIBLE DEBRIDEMENT, OR BELOW KNEE AMPUTATION. AWAITING TREATMENT PLAN. NO UPDATE AS OF (B)(6) 2024. AWAITING PATIENT DECISION RE SURGERY PREFERENCE AS OF (B)(6) 2024."

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 20451694 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A DEVICE EXPLANT SURGERY DUE TO INFECTION CAUSED BY SEPTIC ARTHRITIS FROM THE SPINE THAT TRAVELED THROUGHOUT THE LOWER EXTREMITIES OF HER BODY. THE PATIENT RECEIVED A CEMENT SPACER. THE INFECTION WAS DISCOVERED DURING THE PURULENT DRAINAGE FROM THE LATERAL ASPECT OF THE ANKLE.

  Patient problems: Arthritis; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 18727662 ↗
• InjuryJun 30, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT IS SEEKING COMPENSATION TO ADDRESS THE SURGERY SHE IS GOING TO NEED TO HAVE. PATIENT HAD THIS SURGERY BECAUSE SHE HAD "DEAD BONE" IN HER FOOT. PATIENT NOTICED ISSUES WITH HER ANKLE A COUPLE MONTHS POST THE PROCEDURE. SHE HAD A WRIGHT MEDICAL ANKLE REPLACEMENT IMPLANTED IN (B)(6) 2016 AND NOW THE BUSHING IS LOOSE. DOCTOR DID X-RAYS LAST WEEK AND NOTICED THE DIFFERENCE BETWEEN THE POST-OP X-RAYS AND THE X-RAYS THAT WERE TAKEN LAST WEEK. PATIENT REPORTS THAT THE DOCTOR STATES THAT HE HAS "NEVER SEEN THIS HAPPEN BEFORE". PATIENT USES A CANE TO WALK AND IS IN A LOT OF PAIN AND THE ANKLE IS SWOLLEN AND THIS PROCEDURE HAS AFFECTING EVERY ASPECT OF HER LIFE. PATIENT MAINTAINS SHE ADHERED TO ALL MOBILITY INSTRUCTIONS PROVIDED BY THE PHYSICIAN POST OPERATIVELY.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Implant Pain; Inadequate Osseointegration; Swelling/ Edema

  MAUDE report 17240587 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT SURGERY. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO REASONS THAT WERE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 15325278 ↗