INFINITY 33654408Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840420122797), received between Dec 20, 2021 and Feb 13, 2025 — classified as 6 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2025Osseointegration 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION (INCLUDES DAIR WITH MODULAR EXCHANGE AND MODULAR EXCHANGE FOR INDICATIONS OTHER THAN INFECTION)

  Patient problems: Inadequate Osseointegration

  MAUDE report 21381897 ↗
• InjuryDec 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN (B)(6) 2018 ¿ (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 20840947 ↗
• InjuryNov 14, 2024Adverse 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. SMALL GAPE AT THE DISTAL END OF THE SURGICAL WOUND WITH SOME OOZING. NARRATIVE OF ADVERSE EVENT: PATIENTS WIFE CONTACTED FOOT AND ANKLE HELPLINE REPORTED SMALL GAPE AT THE DISTAL END OF THE PATIENTS WOUND. WAS TO KEEP WOUND CLEAN AND DRY, THERE WERE NO SIGNS OF INFECTION. REVIEWED IN CLINIC (B)(6) 2018, SOME OOZING BUT IMPROVING, CLEANED AND REDRESSED AND TO BE KEPT DRY UNTIL SCAB FORMED."

  Patient problems: Wound Dehiscence

  MAUDE report 20682336 ↗
• InjuryOct 28, 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). PATIENT HAD NUMBNESS."

  Patient problems: Numbness

  MAUDE report 20543325 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING CLINICAL FOLLOW UP THAT THE PATIENT HAD "HOT SWOLLEN RIGHT ANKLE, DEEP SEATED INFECTION DIAGNOSED. EMERGENCY ADMISSION FOLLOWING A MONTH HISTORY OF SWELLING, REDNESS AND HOT RIGHT ANKLE. PATIENT WAS TAKEN TO THEATRE ON FOR A DEBRIDEMENT AND WASHOUT OF ABSCESS ON ANTERIOR ASPECT OF RIGHT ANKLE, FOLLOWED BY SURGERY ON THE FOLLOWING DAY FOR AN EXPLORATION OF LATERAL SIDE OF ANKLE (RIGHT) DEBRIDEMENT CURETTAGE OF CYSTS AND INSERTION OF STIMULATION PLUS CEREMET. TREATED WITH ORAL ANTIBIOTICS FOR 3 MONTHS, INFECTION THEN RESOLVED."

  Patient problems: Bacterial Infection; Cyst(s); Inflammation; Swelling/ Edema

  MAUDE report 17730412 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINS OF RIGHT ANKLE PAIN AND SWELLING. HE HAS PAIN WITH INCREASED WALKING. HE HAS PAIN BOTH MEDIALLY AND LATERALLY. THE PATIENT HAS FAILED CONSERVATIVE MEASURES AND WOULD BENEFIT FROM SURGICAL INTERVENTION. THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 31 MONTHS AFTER INITIAL SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Swelling/ Edema

  MAUDE report 13044395 ↗