INFINITY™ 33680024Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00889797101530), received between Dec 9, 2021 and Jun 15, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 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.

• InjuryJun 15, 2026Loss of Osseointegration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY. IT WAS REPORTED: THE IMPLANTS WERE INITIALLY SIZED AND PLACED CORRECTLY, SECURED CORRECTLY WITH CEMENT BUT DID LOOSEN SLOWLY OVER THE TIMEFRAME AND BECAME MUCH MORE SYMPTOMATIC RECENTLY. THE EVENT APPEARS TO BE A STRAIGHTFORWARD CASE OF MECHANICAL LOOSENING AND SUBSEQUENT SUBSIDENCE".

  Patient problems: Inadequate Osseointegration

  MAUDE report 25512610 ↗
• InjuryJun 15, 2026Fracture

  AS REPORTED: "AN INFINITY ADAPTIS TALAR DOWN PEG BROKE. REVISED BROKEN TALUS IMPLANT TO A NEW ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25512556 ↗
• InjuryMay 19, 2026Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 25222113 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 25122288 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "FATIGUE FRACTURE OF THE MEDIAL MALLEOLUS AFTER TOTAL KNEE REPLACEMENT ON (b)(6)2025, DIAGNOSED ON (b)(6)2026. I (THE PATIENT) HAVE SUFFERED A FATIGUE FRACTURE ON THE RIGHT INNER ANKLE. I WOULD LIKE TO KNOW WHETHER THIS COMPLICATION IS KNOWN. FURTHERMORE, IN THE 13TH POSTOPERATIVE WEEK, I NOTICED SPONTANEOUS NECROSIS IN THE SCAR AREA.NOTE: AS OF (b)(6)2026, THE ONLY X-RAYS AND IMPLANT INFORMATION PROVIDED ARE FOR AN INFINITY ANKLE."

  Patient problems: Limb Fracture; Necrosis

  MAUDE report 24532252 ↗
• 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 JUNE 2025 TO SEPTEMBER 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 23687362 ↗
• 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 23402189 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY WITH ADAPTIS (ITAR2) STUDY (B)(6) 2023. NARRATIVE OF ADVERSE EVENT: THE PATIENT IS A 64 Y.O. YEAR OLD MALE WHO IS HERE FOR FOLLOW UP OF LEFT TAR. HE REPORTS CONTINUED PARESTHESIAS AT THE DORSAL FOREFOOT AND PAIN AT THE MEDIAL ANKLE. HIS PAIN IS OVERALL BETTER COMPARED TO PRE-SURGERY. ON PE, ANKLE MOTION IS 10 DEGREES DORSIFLEXION, 40 DEGREES PLANTARFLEXION. X-RAYS SHOW THE TOTAL ANKLE PROSTHESIS APPEARS STABLE, NO EVIDENCE OF LOOSENING, FRACTURES, AND IN ACCEPTABLE ALIGNMENT. THERE APPEARS TO BE BONY IMPINGEMENT AT THE TIP OF THE MEDIAL MALLEOLUS W/ THE TALUS. I SUSPECT THAT HIS PAIN IS DUE TO MEDIAL ANKLE IMPINGEMENT. OUR NEXT STEP WOULD BE TO EITHER HAVE HIM UNDERGO A DIAGNOSTIC INJECTION OF NUMBING MEDICINE INTO THE MEDIAL ANKLE VERSUS SENDING HIM FOR A SPECT SCAN. HE ELECTS TO PROCEED W/ THE DIAGNOSTIC INJECTION. HE WAS ADVISED TO BE VERY ACTIVE DURING THE NEXT 24 HOURS AND WORK ON ANKLE PUMPS TO DETERMINE THE LEVEL OF RELIEF FROM THE INJECTION. FUTURE OPERATIVE TREATMENT WOULD CONSIST OF A MEDIAL ANKLE GUTTER DEBRIDEMENT IF THE INJECTION WERE TO PROVIDE RELIEF. INJECTION. LEFT ANKLE JOINT. AFTER INFORMED CONSENT WAS OBTAINED, THE INJECTION SITE WAS PR

  Patient problems: Joint Impingement; Numbness; Pain

  MAUDE report 23355590 ↗
• InjuryOct 28, 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 MAY REQUIRE A REVISION SURGERY DUE TO PAIN AND LOOSE TIBIAL TRAY.

  Patient problems: Pain

  MAUDE report 20551778 ↗
• 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). 27 MAY 2022: DORSAL FOOT NEURITIS. PERSISTENT NERVE PAIN. NERVE TINGLING & NUMBNESS-DORSAL FOOT 09 JAN 2023: IMPROVING. HEALING AND PROGRESSING WELL. TREATMENT UPDATED TO INCLUDE ORTHOTICS. 31 JAN 2023: ORTHOTICS, ULTRASOUND GUIDED INJECTION 24 MAY 2023: IMPROVING. SIGNIFICANT RELIEF AFTER ULTRASOUND INJECTION."

  Patient problems: Implant Pain; Numbness

  MAUDE report 20426149 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: 300-034 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: IMP

  Patient problems: Inflammation; Wound Dehiscence

  MAUDE report 20426129 ↗
• 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 20298700 ↗
• InjuryJul 2, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY BECAUSE THE TALUS TOO WIDE AND THE PATIENT IS GETTING SOME IMPINGEMENT. THE PHYSICIAN IS PLANNING A FLAT TOP TALUS REVISION GUTTER CLEAN UP AND POLY SWAP DUE TO PAIN AND LIMITED MOTION.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 19661975 ↗
• InjuryNov 14, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO TALAR IMPLANT SUBSIDENCE AND PAIN.

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

  MAUDE report 18133737 ↗
• InjurySep 1, 2023Migration; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO MARKED ANTERIOR TIBIA SUBSIDENCE WITH TIBIAL TRAY TILTING AS WELL AS PERSISTENT PAIN/SWELLING.

  Patient problems: Implant Pain; Inflammation

  MAUDE report 17671655 ↗
• InjuryMay 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THERE IS AN UPCOMING REVISION SURGERY TO REVISE BOTH TIBIA AND TALUS. THE SURGEONS WANTS TO USE THE INVISION, LIKELY SOME TIBIA BASE BUILD UP AND AN INBONE 2 TIBIAL STEM THAT EXTENDS ENOUGH UP THAT FEELS SECURE. ALSO WILL REVISE THE TALUS COMPONENT AND DROP DOWN A SIZE ON THE TALUS FOR FEEL THE WIDTH OF THE ORIGINAL ONE PUT IN MAY HAVE BEEN A BIT WIDE FOR THE LATERAL GUTTER. ORIGINAL WAS A SIZE 4 INFINITY TIBIA AND SIZE 4 INFINITY CHAMFER TALUS.

  Patient problems: Insufficient Information

  MAUDE report 16898520 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL IMPLANT REMOVED DUE TO INFECTION THAT WAS UNRELATED TO THE TOTAL ANKLE SURGERY. IMPLANT WAS REMOVED AND ANTIBIOTIC CEMENT SPACER WAS INSERTED. ORAL ANTIBIOTICS PRESCRIBED.

  Patient problems: Unspecified Infection

  MAUDE report 16268920 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN OFFICE EVALUATION IT WAS FOUND THAT THE PATIENT HAD MILD WOUND DEHISCENCE IN THE MID PORTION INCISIONAL AREA. MINIMAL SEROSANGUINEOUS DRAINAGE NOTED. THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE SURGEON TOOK MULTIPLE CULTURES, PERFORMED IRRIGATION DEBRIDEMENT OF THE WOUND AND SWAPPED OUT THE POLY. A NEGATIVE PRESSURE WOUND THERAPY WAS APPLIED OVER SMALL AREA OF WOUND DEHISCENCE.

  Patient problems: Wound Dehiscence

  MAUDE report 12970967 ↗