INFINITY™ 33680025Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889797101554), received between Dec 9, 2021 and Sep 23, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Study: Stryker ITAR-2.Site: (b)(6).Subject: (b)(6).Painful right total ankle replacement, four and a half years post-implantation with associated ankle pain, burning sensation, and increased numbness dorsally to the great toe.Procedure Related: Yes.Device Related: No.

  Patient problems: Neuralgia; Numbness; Pain

  MAUDE report 50865171 ↗
• InjuryMay 22, 2026Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF BOTH THE TIBIAL AND TALAR COMPONENTS FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25257092 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY WITH ADAPTIS ANKLE (ITAR-2) STUDY. ON (B)(6) 2021 PATIENT NOTICED NUMBNESS IN LATERAL ASPECT OF RIGHT FOOT ABOUT 2 MONTHS AFTER OPERATION. NO PAIN WAS REPORTED. THE NUMBNESS IS REPORTED ON THE OPERATIVE ANKLE. ADDITIONALLY, SEVERAL AE UPDATES WERE PROVIDED. AE UPDATE (B)(6) 2022: PATIENT REPORTS NO PAIN BUT HAS NUMBNESS AND A STINGING SENSATION IN FOOT AFTER PROLONGED WALKING. AE UPDATE 2 (B)(6) 2023: NUMBNESS STILL REPORTED. ON (B)(6) 2025: AFTER REVIEW BY THE MEDICAL EXPERT THIS AE WAS QUERIED TO DETERMINE IF IT WAS PROCEDURE RELATED DUE TO PROXIMITY TO THE SURGERY. THE STUDY COORDINATOR REPLIED AFTER CONFIRMING WITH THE PI THAT THE NUMBNESS WAS PROCEDURE RELATED DUE TO ANESTHESIA BLOCK.

  Patient problems: Numbness

  MAUDE report 23347796 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: 200-009 INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6) 2022: DELAYED WOUND HEALING. SMALL OPEN WOUND NOTED. PATIENT REFERRED TO WOUND CARE MANAGEMENT. (B)(6) 2022: IMPROVING. SLIGHT REDNESS THAT IS HEALING. (B)(6) 2022: RESOLVED. CLEAN, DRY, AND INTACT WITHOUT SIGNS OF INFECTION."

  Patient problems: Wound Dehiscence

  MAUDE report 20426084 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2023 WITH STRESS REACTION, MEDIAL ANKLE. PAIN & SWELLING OVER MEDIAL SUPRAMALLEOLAR REGION. THE PATIENT DENIES INJURY OR TRAUMA. THE SYMPTOMS WERE WORSE WITH WEIGHT BEARING. THE PATIENT WAS TREATED WITH MEDICATION, BOOT AND ICE. ON (B)(6) 2023, THE PATIENT REPORTED THAT THE PAIN IMPROVED BUT NOT COMPLETELY RESOLVED.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 17686754 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POSTOPERATIVE WOUND DEHISCENCE WITH TENDON EXPOSURE. NO DEEP INFECTION APPRECIATED, BUT IN PATIENTS BEST INTEREST TO PERFORM SURGICAL IRRIGATION AND DEBRIDEMENT. PATIENT UNDERWENT SURGICAL I&D COMPLETED WITH ANTIBIOTIC POWDER TO WOUND AND WOUND VAC PLACEMENT. MOST RECENT POST OP NOTE ON NOTES INCISION HEALING WELL. PATIENT SEEING WOUND CARE WEEKLY TO CHANGE DRESSINGS AND MONITOR PROGRESS. PHYSICIANS NOTE ON (B)(6) 2021 STATES THAT WOUND DEHISCENCE STILL PRESENT. REFERRAL TO PLASTIC SURGERY AND PLAN FOR DEBRIDEMENT AND COVERAGE ON (B)(6) 2021. PATIENT STATES THAT OVERALL ANKLE FEELS MUCH BETTER COMPARED TO PRE-OPERATIVELY. SKIN GRAFT DID NOT TAKE AT THE ANTERIOR ASPECT OF THE WOUND. NO EXPOSED TENDON. NOTICEABLE DISCOLORATION VASCULOPATHY CHANGES OF THE LOWER LEG. PATIENT STATE THAT THEY ARE CONSIDERING A MUSCLE FLAP FOR COVERAGE. POSSIBLE REFERRAL TO VASCULAR SPECIALIST TO CONFIRM ADEQUATE BLOOD SUPPLY GIVEN THE ONGOING WOUND HEALING SINCE FEBRUARY. PATIENT STATES THAT HIS ANKLE FEELS BETTER THAN IT DID PRE-OPERATIVELY. VERY PLEASED WITH HIS ANKLE.

  Patient problems: Wound Dehiscence

  MAUDE report 12969210 ↗