INFINITY ADAPTIS 33680004Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00889797069663), received between Dec 1, 2022 and Jun 8, 2026 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (16 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Loss of Osseointegration

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 FOR THE MONTHLY REPORT OF MAY 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING OF TIBIAL COMPONENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 25426886 ↗
• InjuryMay 1, 2026Insufficient 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 25057141 ↗
• InjuryJan 27, 2026Loss of Osseointegration; Osseointegration Problem

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO PROGRESSIVE ANTERIOR TIBIAL SUBSIDENCE AS WELL AS POSTERIOR TALAR LUCENCY CONSISTENT WITH SUBCHONDRAL CYST FORMATION DUE TO ABNORMAL ANKLE JOINT MECHANICS/PRESSURES.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 24194246 ↗
• InjuryOct 28, 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. ANKLE IMPINGEMENT SYNDROME. PERSISTENT PAIN. PHYSICIANS NOTE DOCUMENTS LIMITED DORSIFLEXION AND ANTERIOR IMPINGEMENT PAIN. PLAN FOR ARTHROSCOPIC DEBRIDEMENT ANTERIORLY TO HELP WITH PAIN AND MAY IMPROVE MOTION ALSO. OPERATION PERFORMED (B)(6) 2021: PATIENT UNDERWENT REOPERATION FOR RIGHT ANKLE ARTHROSCOPIC DEBRIDEMENT. AE UPDATE 11-JAN-2022: PATIENT REPORTS ARE IMPROVING. DIRECTED TO WEIGHT BEAR AS TOLERATED AND AGGRESSIVE PHYSICAL THERAPY WORKING ON RANGE OF MOTION RECOMMENDED.

  Patient problems: Joint Impingement; Pain

  MAUDE report 23402215 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). STUDY: STRYKER ITAR-2 - INFINITY WITH ADAPTIS. GUTTER IMPINGEMENT: NARRATIVE OF ADVERSE EVENT : PATIENT PRESENTED WITH CONTINUED PAIN IN HIS MEDIAL ANKLE. EXAM OF ANKLE FOUND SLIGHT ANKLE VARUS, TENDERNESS PALPATION OVER THE MEDIAL GUTTER, ESPECIALLY DISTALLY. ISOLATED RIGHT ANKLE MEDIAL GUTTER DEBRIEDMENT PERFORMED.

  Patient problems: Joint Impingement; Pain

  MAUDE report 23402204 ↗
• InjurySep 17, 2025Osseointegration Problem; Implant subsidence; Osseointegration Problem; Implant subsidence

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT REVISION SURGERY MAY BE REQUIRED. A TOTAL ANKLE REPLACEMENT WITH A WRIGHT MEDICAL/STRYKER DEVICE WAS PREVIOUSLY PERFORMED FOR ARTHRITIS AND ANKLE PAIN. REPORTS INCLUDE SWELLING AND MEDIAL ANKLE PAIN, WITH IMAGING SUGGESTING A POSSIBLE MEDIAL MALLEOLUS STRESS FRACTURE AND POTENTIAL TIBIAL TRAY LOOSENING. NO REVISION HAS BEEN PERFORMED TO DATE. BONE QUALITY WAS DESCRIBED AS GOOD, AND COMPLIANCE WITH MOBILIZATION INSTRUCTIONS WAS NOTED, THOUGH A PHYSICALLY ACTIVE LIFESTYLE MAY HAVE CONTRIBUTED TO THE REPORTED SYMPTOMS.

  Patient problems: Cyst(s); Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 23074454 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(4). STUDY: STRYKER ITAR-2 - INFINITY WITH ADAPTIS. TALAR COMPONENT IMPINGEMENT AND CONTINUED PAIN. SUBJECT CONTINUES TO HAVE SUSTAINED ANTERIOR MEDIA ANKLE AND DISTAL TIBIAL PAIN. PAIN IS LIKELY DUE TO IMPINGEMENT BETWEEN HIS MEDIAL MALLEOLUS AND TALAR COMPONENT, LIKELY RELATED TO HIS MILD VARUS ALIGNMENT.

  Patient problems: Implant Pain; Joint Impingement

  MAUDE report 22961234 ↗
• InjuryAug 20, 2025Loss of Osseointegration; Insufficient Device Problem Information; Migration; Loss of Osseointegration; Insufficient Device Problem Information; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO IMPLANT FAILURE.

  Patient problems: Cyst(s); Inadequate Osseointegration; Insufficient Information

  MAUDE report 22853875 ↗
• InjuryJul 18, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT HAS PAIN AT THE ANKLE JOINT MAY REQUIRE A REVISION SURGERY OF BOTH THE TIBIAL AND TALAR COMPONENTS. IT LOOKS LIKE THE PRIMARY TIBIAL CUT WAS OFF AXIS AND THE ANKLE IS IN VARUS AND THE PHYSICIAN IS TRYING TO DETERMINE IF THE PATIENT NEEDS A TIBIA OSTEOTOMY AND LEAVE THE ANKLE OR IGNORE THE TIBIA AND REVISE THE TIBIA SO IT¿S NOT IN VARUS.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22547056 ↗
• InjuryJul 2, 2025Osseointegration Problem; Implant subsidence; Osseointegration Problem; Implant subsidence

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY BECAUSE THE TIBIAL COMPONENT IS LOOSE AND THERE IS ANTERIOR SUBSIDENCE. THE PATIENT IS ALSO COMPLAINING OF PAIN. THE TALAR IMPLANT WILL BE REVISED TO MATCH THE TIBIAL INBONE COMPONENT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22383466 ↗
• InjuryJun 17, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO TIBIAL COMPONENT LOOSENING AND CLINICAL PAIN. THE SURGEON PLANS TO REVISE BOTH THE TIBIA AND TALUS.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22231191 ↗
• InjuryMay 20, 2025Osseointegration Problem; Insufficient Device Problem Information; Implant subsidence; Osseointegration Problem; Insufficient Device Problem Information; Implant subsidence

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR THE UPCOMING REVISION SURGERY. IT WAS ALSO REPORTED THAT THERE WAS: "SINTERING OF THE TIBIAL COMPONENT WITH TILTING, INTERNAL MALLEOLUS FRACTURE."

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 22053983 ↗
• InjuryFeb 26, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF TIBIAL COMPONENT FOR REASON OF LOOSENING OF TIBIA AND ONGOING PAIN .

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21475139 ↗
• InjuryFeb 26, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF TIBIAL COMPONENT FOR REASONS OF LOOSE TIBIAL TRAY AND ASEPTIC LOOSENING OF THE TIBIA WITH ONGOING PAIN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21471115 ↗
• InjuryFeb 26, 2025Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "SUBJECT: (B)(6). INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). ASEPTIC LOOSENING: SUBJECT REPORTED GRADUAL WORSENING PAIN IN THE STUDY ANKLE. [THE SURGEON'S] PA NOTED THAT THE PAIN SEEMED "SOMEWHAT MIGRATORY AROUND THE ANTERIOR ANKLE, MEDIAL AND LATERAL HINDFOOT EVEN UP INTO THE LOWER LEG WITH SOME TENDERNESS MEDIALLY ALONG TIBIA." PA DID NOT NOTE ANY SUBSIDENCE OF HARDWARE ON X-RAYS. SUBJECT RECEIVED FLUOROSCOPIC GUIDED RIGHT SUBTALAR JOINT INJECTION AS TREATMENT. (B)(6) 2023: WORSENING. LOOSENING OF TIBIAL COMPONENT NOTED ON X-RAYS. (B)(6) 2023: NO CHANGE. NO PROGRESSION OF LOOSENING. PI ATTRIBUTED ANKLE PAIN TO LOOSENING AT THIS VISIT. (B)(6) 2024: PAIN WAS RESOLVED AND X-RAYS SHOWED NO FURTHER PROGRESSION. RESOLVED WITHOUT SEQUELAE."

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 21468381 ↗
• InjuryNov 13, 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 TIBIAL COMPONENT LOOSENING.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 20679624 ↗
• 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: WOUND DEHISCENCE. DELAYED WOUND HEALING. SMALL AREA OF WOUND DEHISCENCE NOTED IN THE FLAP AREA OF THE INCISION AT THE 3 WEEK POST OP VISIT. RECOMMENDATIONS INCLUDED XEROFORM DRY DRESSING CHANGES DAILY, WASH WITH SOAP AND WATER, CONTINUE NONWEIGHT BEARING, AND FOLLOW-UP IN 1 WEEK. (B)(6) 2022: IMPROVING. INCISION IS HEALING WELL. 1 SMALL AREA OF ESCHAR. FOLLOW-UP 2-3 WEEKS. (B)(6) 2022: WORSENING. REDNESS AROUND INCISION SITE WITH NEW DRAINAGE. RECOMMEND IRRIGATION AND DEBRIDEMENT WITH IV ANTIBIOTICS AND REVISION WITH POLY EXCHANGE. EVERLAST POLY WAS REMOVED AND DISCARDED. (B)(6) 2022: IMPROVING. (B)(6) 2022: IMPROVING. INCISION HEALING WELL. MEDIHONEY AND GAUZE DRESSING. DAILY DRESSING CHANGES. OKAY TO WASH WITH SOAP AND WATER. NONWEIGHT BEARING. HOME PT, VERY GENTLE ANKLE RANGE OF MOTION. (B)(6) 2022: IMPROVING. INCISION HEALING WELL. INCISION HAS ALMOST FULLY HEALED, JUST 1 PINPOINT AREA THAT HE CAN CONTINUE MEDIHONEY AND GAUZE IN THE NEXT FEW DAYS UNTIL THIS HEALS UP. GRADUAL PROGRESSION TO FULL WEIGHTBEARING IN THE TALL BOOT. COMMENCE PHYSICAL THERAPY. (B)(6) 2022: IMPR

  Patient problems: Inflammation; Wound Dehiscence

  MAUDE report 20426141 ↗
• 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: DORSAL FOOT NEURITIS. PERSISTENT NERVE PAIN. NERVE TINGLING & NUMBNESS-DORSAL FOOT. (B)(6) 2023: IMPROVING. HEALING AND PROGRESSING WELL. TREATMENT UPDATED TO INCLUDE ORTHOTICS. (B)(6) 2023: ORTHOTICS, ULTRASOUND GUIDED INJECTION. (B)(6) 2023: IMPROVING. SIGNIFICANT RELIEF AFTER ULTRASOUND INJECTION."

  Patient problems: Implant Pain; Numbness

  MAUDE report 20426094 ↗
• InjuryOct 1, 2024Osseointegration Problem; Osseointegration Problem

  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 DUE TO SUBSIDENCE.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 20344523 ↗
• InjuryJul 18, 2024Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 19777607 ↗
• InjuryJun 26, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO IMPLANT LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19620748 ↗
• InjuryJun 24, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  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 DUE TO LOOSENING OF THE TIBIAL COMPONENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19601676 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; 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: Cyst(s); Insufficient Information

  MAUDE report 19262571 ↗
• InjuryNov 7, 2023Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PHYSICIAN NOTED THAT TIBIAL COMPONENT WILL HAVE TO BE REVISED DUE TO BEING LOOSE AND IN VARUS. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND COLLAPSED. THE PATIENT MAY REQUIRE A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 18088284 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED 6 WEEKS POST PROCEDURE WITH MRSA INFECTION. THE PHYSICIAN EXPLANTED ALL IMPLANTS AND IMPLANTED A CEMENT SPACER.

  Patient problems: Bacterial Infection; Fluid Discharge; Wound Dehiscence

  MAUDE report 17599446 ↗