INFINITY™ 33680022Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00889797101523), received between Nov 1, 2021 and Jan 26, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Adverse 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 PERSISTENT PAIN.

  Patient problems: Pain

  MAUDE report 24184410 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  SUBJECT: (B)(6). INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6) 2022: PATIENT REPORTS PAIN IN LEFT ANKLE. PATIENT HAS SOME TENDERNESS SUB FIBULAR IMPINGEMENT AREA. CT PROPHECY PROTOCOL DONE TO ENSURE THAT IMPLANT IS NOT LOOSE. (B)(6) 2023: SURGICAL INTERVENTION INVOLVING EXPLANT OF DEVICE DUE TO ASEPTIC LOOSENING. PATIENT DISCHARGED ON (B)(6) 2023.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 23536171 ↗
• InjurySep 9, 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. SUBJECT HAS PERSISTENT PAIN IN HIS LEFT ANKLE.

  Patient problems: Pain

  MAUDE report 23001788 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: STRYKER ITAR-2. SUBJECT: (B)(6). (B)(6) 2024: PI REVIEWED HER SPECT/CT SCAN WITH HER TODAY, AND PI FEELS THAT HER IMAGES ARE MOST CONSISTENT WITH LATERAL GUTTER IMPINGEMENT. THIS IS ALSO CONCORDANT WITH HER EXAM AND FOCAL PAIN IN THE LATERAL GUTTER. PATIENT ELECTED TO PROCEED WITH A GUTTER DEBRIDEMENT. TREATMENT FOR THIS CONDITION WOULD CONSIST OF A LATERAL GUTTER DEBRIDEMENT. (B)(6) 2024: PATIENT HAD SURGERY ON THIS DAY FOR A RIGHT ANKLE ARTHROTOMY AND BONY DEBRIDEMENT OF LATERAL GUTTER.

  Patient problems: Joint Impingement; Pain

  MAUDE report 22963654 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). STUDY: (B)(4). SUBJECT HAS INTERMITTENT SWELLING STILL PRESENT.

  Patient problems: Swelling/ Edema

  MAUDE report 22961240 ↗
• InjurySep 4, 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. SUBJECT HAS SOME NEW NUMBNESS ALONG THE PLANTAR DISTAL TOES.

  Patient problems: Numbness

  MAUDE report 22961232 ↗
• InjuryJul 23, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO GUTTER IMPINGEMENT AND POSSIBLE LOOSENING OF PROSTHESES.

  Patient problems: Inadequate Osseointegration; Joint Impingement; Pain

  MAUDE report 22580193 ↗
• InjuryMar 18, 2025Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; 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 DUE TO IMPLANT SIZE.

  Patient problems: Implant Pain; Pain

  MAUDE report 21636843 ↗
• InjuryFeb 26, 2025Adverse 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) 2021: WORSENING REDNESS AROUND INCISION. DELAYED WOUND HEALING. NO EVIDENCE OF DEEP INFECTION, HOLD MOTION, CONTINUE SOAP AND WATER WASH, BACTRIM ANTIBIOTIC PRESCRIBED. (B)(6) 2021: WORSENING. SMALL AREA OF WOUND DEHISCENCE WITH MILD EXUDATE MILD ERYTHEMA. NO PURULENT DRAINAGE, NO SIGNS OF DEEP INFECTION. CONTINUE WET-TO-DRY DRESSINGS OVER SMALL AREA OF WOUND DEHISCENCE. (B)(6) 2021: NO CHANGE. WOUND DEBRIDED IN OFFICE. HOLD MOTION FOR ANOTHER WEEK. (B)(6) 2021: IMPROVING. WOUND APPEARS LESS IRRITATED, CONTINUE WET-TO-DRY DRESSINGS, REFERRAL TO WOUND CARE. (B)(6) 2021: IMPROVING. GRANULATION TISSUE BED LOOKS EXCEPTIONAL. WOUND APPEARS TO BE RESPONDING EXCELLENT. BACTRIM TO BE CAUTIOUS. (B)(6) 2021: IMPROVING. INCISION HEALING. MILD WOUND DEHISCENCE. MUCH IMPROVED. CONTINUE WITH WOUND CARE. (B)(6) 2021: IMPROVING. INCISION HEALING WELL. MUCH IMPROVED. (B)(6) 2021: RESOLVED. INCISION HEALED. NO DRAINAGE. NO SIGNS OF INFECTION."

  Patient problems: Erythema; Wound Dehiscence

  MAUDE report 21468382 ↗
• InjuryJan 3, 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 BOTH THE TIBIAL AND TALAR COMPONENTS DUE TO FAILURE OF TIBIAL INGROWTH WITH SECONDARY STRESS FRACTURE MEDIAL MALLEOLUS.

  Patient problems: Bone Fracture(s); Cyst(s); Inadequate Osseointegration

  MAUDE report 21071406 ↗
• InjuryDec 10, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF TALAR COMPONENT FOR REASONS OF LOOSE COMPONENT. PLAN TO REVISE TO INBONE TALUS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20891207 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6), STUDY: STRYKER ITAR-2 - INFINITY WITH ADAPTIS. PERSISTENT NERVE PAIN. SUBJECT CONTINUES TO HAVE PAIN IN HER ANKLE AND HAS SIGNIFICANT SWELLING, WHICH IS WORSE AT THE END OF THE DAY. SHE DESCRIBES A BURNING PAIN OVER THE ANTERIOR ANKLE."

  Patient problems: Extraskeletal ossification; Joint Impingement; Neuralgia; Swelling/ Edema

  MAUDE report 20854444 ↗
• 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) ON (B)(6) 2021: INTRA-OPERATIVE FRACTURE (R LATERAL DISTAL TIBIAL FX). AFTER MAKING TIBIAL CUT, A FRACTURE WAS NOTED IN R LAT DISTAL TIBIA-NON-DISPLACED. NO ADDITIONAL PROCEDURES OR FIXATION WAS NEEDED. COMPONENTS WERE STABLE, ANKLE WAS STABLE AT END OF PROCEDURE."

  Patient problems: Bone Fracture(s)

  MAUDE report 20426123 ↗
• 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) 2021: SUPERFICIAL WOUND DEHISCENCE, NO SIGN OF DEEP INFECTION. HEALED WITH LOCAL WOUND CARE AND PO ANTIBIOTIC. NO FUTURE SURGERY REQUIRED.".

  Patient problems: Wound Dehiscence

  MAUDE report 20426076 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: 200-003INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) (B)(6) 2021: PERSISTENT PAIN. PATIENT STATES SHE IS HAVING SIGNIFICANT PAIN ON THE MEDIAL ASPECT OF HER ANKLE. (B)(6) 2022: RESOLVED. DENIES PAIN AT OFFICE VISIT.".

  Patient problems: Implant Pain

  MAUDE report 20426067 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use 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 PAIN AND LOOSE TIBIAL TRAY.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 18479643 ↗
• InjuryNov 22, 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 MAY REQUIRE A REVISION SURGERY DUE TO PAIN AND TIBIAL TRAY LOOSENING.

  Patient problems: Implant Pain

  MAUDE report 18196249 ↗
• InjurySep 15, 2023Osseointegration Problem; Insufficient Device Problem Information; Osseointegration Problem; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO CONTINUED PAIN FOR TWO YEARS SINCE THE IMPLANT PROCEDURE. THE PHYSICIAN PRESUMES LOOSENING WITH ASSOCIATED PAIN.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 17757701 ↗
• InjuryJul 6, 2023Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT GETS A STRESS FRACTURE AND IMPLANT LOOSENING FOLLOWING STRESS FRACTURE. THE PATIENT WILL BE UNDERGOING A REVISION PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s)

  MAUDE report 17264121 ↗
• InjuryNov 1, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT SURGERY. ALLEGEDLY, THE PATIENT WILL NEED TO UNDERGO A REVISION SURGERY DUE TO TALOR COMPONENT COLLAPSE. WITHIN PAST COUPLE OF MONTHS, TALUS/IMPLANT STARTING TO COLLAPSE AND FORCING IMPLANT ANTERIOR AND STRUCTURE NO LONGER SUPPORTIVE AS SEEN ON CURRENT LATERAL WEIGHT BEARING X-RAY.

  Patient problems: Failure of Implant

  MAUDE report 12733221 ↗