INFINITY ADAPTIS 33680015Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00889797069700), received between Dec 9, 2021 and Sep 23, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

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

  Study: (b)(6). Site: 200 --- (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 50865159 ↗
• InjuryMay 8, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 2024 -2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION ACTIVE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 25122287 ↗
• InjuryDec 1, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 (B)(6) 2025 TO (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO LYSIS IN TALUS AND INFECTION - ACTIVE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23687364 ↗
• InjuryNov 20, 2025Loss of Osseointegration; Implant subsidence; Loss of Osseointegration; Implant subsidence

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO ASEPTIC LOOSENING AND SUBSIDENCE OF THE TIBIAL COMPONENT.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 23607422 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY WITH ADAPT IS ANKLE (ITAR-2) STUDY. (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 1 09-NOV-2022: PATIENT REPORTS NO PAIN BUT HAS NUMBNESS AND A STINGING SENSATION IN FOOT AFTER PROLONGED WALKING. AE UPDATE 2 01-NOV-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 23347797 ↗
• InjuryMay 20, 2025Osseointegration Problem; Implant subsidence; Osseointegration Problem; Implant subsidence

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT IS EXPERIENCING PAIN AND MAY REQUIRE A REVISION SURGERY. THE PHYSICIAN BELIEVES THAT THE TIBIAL COMPONENT HAS SUBSIDED AND MAY BE LOOSE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22056786 ↗
• InjuryMay 7, 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 FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 21980880 ↗
• InjuryApr 16, 2025Adverse 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 MAY REQUIRE REVISION SURGERY DUE TO AN INFECTION. THE WOUND REPORTEDLY DEVELOPED IN LATE FEBRUARY OR EARLY MARCH. NOTABLY, FOOT DROP RELATED TO A PREOPERATIVE NERVE BLOCK WAS IDENTIFIED AS A REMARKABLE CIRCUMSTANCE IN THIS EVENT. A REVISION SURGERY IS PLANNED FOR MID TO LATE (B)(6).

  Patient problems: Loss of Range of Motion; Nerve Damage; Post Operative Wound Infection

  MAUDE report 21849766 ↗
• InjuryOct 28, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO PAIN AND LOOSE TIBIAL TRAY.

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

  MAUDE report 20550176 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) 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 20426133 ↗
• InjuryOct 2, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE TIBIAL IMPLANT AND FRACTURE OF TIBIA AROUND IMPLANT.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 20352186 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ADAPTIS SUBJECT (B)(6) PATIENT PRESENTED TO CLINIC ON (B)(6) 2022 (5 WEEKS AND 5 DAYS S/P LEFT TAR PROCEDURE), C/O PLANTAR NUMBNESS AND DIFFICULTY WITH TOE FLEXION. UPON EXAM, THE SURGEON CONFIRMED SUPERFICIAL AND PERONEAL NERVES ARE INTACT. SURAL NERVE IS INTACT. THE SURGEON ORDERED AN EMG; ON (B)(6) 2022 EMG REPORT/CLINICAL IMPRESSION: PATIENT HAS COMPRESSIVE NEUROPATHY AT LEFT TARSAL TUNNEL AND FIBULAR HEAD, DUE TO POSTOP SWELLING, CASTING, AND THE BOOT. F/U PENDING. UPDATE 07 MAR 2023: PATIENT CONTINUES TO HAVE TIBIAL NERVE IRRITATION. THE SURGEON DOES NOT BELIEVE THIS EVENT IS DUE TO A TRAUMATIC TIBIAL NERVE LACERATION DURING TAR PROCEDURE, BUT RESIDUAL IRRITATION FROM THE NERVE BLOCK OR SWELLING."

  Patient problems: Loss of Range of Motion; Neuropathy; Numbness; Swelling/ Edema

  MAUDE report 20307753 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: 100-004 INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) PATIENT HAS WOUND BREAKDOWN IN THE MIDDLE PORTION OF THE INCISION."

  Patient problems: Wound Dehiscence

  MAUDE report 20298708 ↗
• InjuryJun 25, 2024Unintended Movement; Unintended Movement

  AS REPORTED: "ADVERSE EVENT : IMPLANT FAILURE NARRATIVE OF ADVERSE EVENT : IMPLANT FAILED. LOOSENING AND SUBSIDENCE WAS NOTICED ON IMAGING POST-OP ON 19 JAN 2024. IT NEEDS TO BE REMOVED AND REPLACED." REVISION SURGERY WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 19608313 ↗
• InjuryMay 31, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF BOTH TIBIAL AND TALAR COMPONENTS DUE TO LOOSENING.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 19436347 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2): SUBJECT: (B)(6). AS REPORTED: "LEFT ANKLE PAIN, SWELLING, AND NUMBNESS. PATIENT WAS SEEN FOR 3 MONTH FOLLOW UP OF LEFT ANKLE ON (B)(6) 2023 WITH COMPLAINTS OF PAIN, SWELLING, AND NUMBNESS SINCE LAST VISIT ON (B)(6) 2023. MOST OF THE PAIN WAS REPORTED OUTSIDE ASPECT OF ANKLE. EXAMINATION SHOWED WELL-HEALED SCAR WITH TENDERNESS OF LEFT SUBTALAR JOINT WITH MINIMAL DISCOMFORT LATERAL ASPECT OF THE ANKLE. RADIOGRAPHIC IMAGING SHOWED NO EVIDENCE OF LUCENCY. AROUND THE HARDWARE. PATIENT IS TO CONTINUE WEARING BOOT, PHYSICAL THERAPY, USE VOLTAREN GEL, AND STABILIZE THE ANKLE WITH PRESCRIBED LACE-UP ANKLE BRACE."

  Patient problems: Discomfort; Implant Pain; Numbness; Swelling/ Edema

  MAUDE report 17864750 ↗
• InjuryJul 28, 2023Adverse 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 EXPLANATION SURGERY DUE TO INFECTION. THE PATIENT RECEIVED A CEMENT SPACER IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17413479 ↗
• 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 FROM 05/12/2021 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 (B)(6). PATIENT STATES THAT HIS ANKLE FEELS BETTER THAN IT DID PRE-OPERATIVELY. VERY PLEASED WITH HIS ANKLE.

  Patient problems: Wound Dehiscence

  MAUDE report 12969190 ↗