INFINITY ADAPTIS 33680013Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00889797069687), received between Nov 2, 2021 and Mar 31, 2026 — classified as 52 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (22 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 53 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS FALLEN INTO VARUS AND THE PHYSICIAN WOULD LIKE TO REVISE THE TAR.

  Patient problems: Malunion of Bone

  MAUDE report 24744526 ↗
• InjuryFeb 25, 2026Fracture; Loss of Osseointegration

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO PAIN, LOOSENING OF THE TIBIAL IMPLANT AS WELL AS THE BROKEN PEG.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 24447086 ↗
• InjuryJan 15, 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 24081745 ↗
• InjuryDec 23, 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 23875439 ↗
• InjuryDec 22, 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 PATIENT FELL DOWN THE STAIRS AND CONTINUES TO HAVE PAIN AND SWELLING. THERE'S CONCERNS FOR SUBSIDENCE OF THE TIBIAL COMPONENT.

  Patient problems: Ambulation or Postural Difficulties; Fall; Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 23872998 ↗
• 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) ON (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. ON (B)(6) 2023: SURGICAL INTERVENTION INVOLVING EXPLANT OF DEVICE DUE TO ASEPTIC LOOSENING. PATIENT DISCHARGED (B)(6) 2023.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 23536492 ↗
• InjurySep 15, 2025Osseointegration Problem; Implant subsidence; Osseointegration Problem; Implant subsidence

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY. THE REASON FOR THE REVISION IS DUE TO SUBSIDENCE OF THE TIBIAL COMPONENT, MALALIGNMENT, AND MIGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23057828 ↗
• 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 23001822 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Swelling/ Edema

  MAUDE report 22961310 ↗
• 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 22961231 ↗
• 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 22580161 ↗
• InjuryJul 11, 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 A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 22480006 ↗
• InjuryJun 30, 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 OF BOTH TIBIAL AND TALAR COMPONENTS DUE TO SUBSIDENCE OF THE TIBIAL IMPLANT.

  Patient problems: Fall; Inadequate Osseointegration; Insufficient Information

  MAUDE report 22362319 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(4) INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). 25 AUG 2022: SURGICAL INTERVENTION. MULTIPLE INJURIES TO STUDY ANKLE REQUIRING SURGICAL INTERVENTION. PARTIAL EXCISION OF FIBULA FOR OSTEOMYELITIS TRANSFER OF ADJACENT TISSUE. THIS EVENT IS CAPTURED UNDER STRYKER REFERENCE #'S (B)(4). UPDATE 01 SEP 2022: NO CHANGE. SUTURES REMAIN, DRY DRESSING APPLIED. WALKING BOOT CONTINUED. WEIGHT-BEAR FOR TOLERATED IN THE WALKING BOOT. UPDATE 05 OCT 2022: WORSENING. PATIENTS ENTIRE ANKLE JOINT IS INFECTED SUBSEQUENT FROM SEEDING POSTEROLATERAL. PATIENT NOTED SWELLING AND CHILLS. WILL DO CULTURES IMPLANT REMOVAL IRRIGATION DEBRIDEMENT, ANTIBIOTIC SPACER, AND ADMISSION WITH IV ANTIBIOTICS. UPDATE 11 OCT 2022: SURGICAL INTERVENTION DUE TO DEEP INFECTION. REOPERATION WITH REMOVAL OF TIBIAL AND/OR TALAR IMPLANTED COMPONENTS. THIS EVENT IS CAPTURED THIS RECORD."

  Patient problems: Bacterial Infection; Swelling/ Edema

  MAUDE report 21572306 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) INFINITY WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) (B)(6) 2022: ON (B)(6) 2022, A PATIENT WAS PRESENTED WITH LATERAL ANKLE LACERATION FROM A BUSH HOGGING ACCIDENT ON (B)(6) 2022. THEY ORIGINALLY HAD 8 STITCHES BUT CUT THEM AT HOME A WEEK AFTER THAN BEING PLACED WHICH HAS LED TO WOUND DEHISCENCE. IT IS FAIRLY DEEP WITH SEROSANGUINEOUS DRAINAGE. KEFLEX X7 DAYS. DISCUSSED SIGNS AND SYMPTOMS OF INFECTION TO MONITOR FOR AND DRY DRESSING CHANGES EITHER DAILY OR TWICE A DAY DEPENDING ON DRAINAGE TO THE LATERAL LACERATION. UPDATE 24 AUG 2022: WORSENING. PLAN FOR RIGHT ANKLE IRRIGATION AND DEBRIDEMENT, BONE BIOPSY, PARTIAL EXCISION OF FIBULA, WITH POSSIBLE ADJACENT TISSUE TRANSFER. UPDATE 25 AUG 2022: SURGICAL INTERVENTION. MULTIPLE INJURIES TO STUDY ANKLE REQUIRING SURGICAL INTERVENTION. PARTIAL EXCISION OF FIBULA FOR OSTEOMYELITIS TRANSFER OF ADJACENT TISSUE."

  Patient problems: Osteomyelitis; Wound Dehiscence

  MAUDE report 21572304 ↗
• InjuryMar 4, 2025Adverse 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 REQUIRES A REVISION SURGERY DUE TO A MEDIAL MALLEOLUS FRACTURE THAT IS NOT HEALING AND LUCENCY UNDER THE TIBIAL IMPLANT. BOTH SIDES ARE BEING REVISED. THE SURGERY WAS COMPLETED AND ALL COMPONENTS WERE EXPLANTED AND A CEMENT SPACER WAS PLACED.

  Patient problems: Bone Fracture(s); Impaired Healing; Inadequate Osseointegration; Nonunion/Delayed-union Bone Fracture; Osteolysis

  MAUDE report 21515537 ↗
• 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 21468385 ↗
• InjuryFeb 25, 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 TIBIAL AND TALAR COMPONENTS DUE TO LOOSENING OF TIBIAL PLATE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21463943 ↗
• InjuryFeb 7, 2025Osseointegration 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 A FAILED TIBIAL COMPONENT.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 21333272 ↗
• InjuryOct 9, 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: DROPFOOT. PATIENT SEEN ON (B)(6) 2022, FOR FOLLOW UP AND TO CONSIDER LEFT LOWER EXTREMITY NERVE CONDUCTION STUDY/EMG ORDERED TO EVALUATE DROP FOOT IF NOT IMPROVED BY NEXT VISIT. PATIENT STATED HE NOTICED THIS EVER SINCE COMING OUT OF CAST AND STARTING ANKLE RANGE OF MOTION EXERCISES AT HOME WHEN HE CANNOT ACTIVELY BRING HIS FOOT UP. (B)(6) 2022: IMPROVING. PATIENT IS SHOWING SOME ELEMENT OF FIRING DORSIFLEXORS, NO EMG NERVE CONDUCTION STUDY AT THIS TIME. MAY EVENTUALLY REQUIRE EMG NERVE CONDUCTION STUDY."

  Patient problems: Loss of Range of Motion; Nerve Damage

  MAUDE report 20407857 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). PROGRESSIVE OSTEOLYTIC LESIONS (IDENTIFIED BY CT) PATIENT WHO IS 1.5 YEARS OUT FROM TAA EXPRESSES PERSISTENT PAIN. X-RAYS AND CT REVEALED CYSTIC LUCUENCY AT THE TIBIAL BONE-PROTHESIS INTERFACE, INCREASED AS COMPARED TO HIS PRIOR CT. PATIENT WAS RECOMMENDED SURGERY FOR TAA EXPLANT AND REVISION. PATIENT WISHED TO PROCEED WITH SURGERY. REVISION SURGERY WITH DEVICE EXPLANT ON (B)(6) 2024."

  Patient problems: Implant Pain; Osteolysis

  MAUDE report 20298697 ↗
• InjuryJul 22, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY BECAUSE THE TIBIAL AND TALAR COMPONENTS ARE LOOSE. THE PATIENT WAS NON COMPLIANT AFTER SURGERY AND WEIGHT PLAYED A FACTOR.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19798990 ↗
• InjuryJul 12, 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 LOOSENING.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 19732149 ↗
• InjuryJun 28, 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 THE TIBIAL COMPONENT DUE TO ASEPTIC LOOSENING.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 19634399 ↗
• InjuryMay 23, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO TALAR BONE LOSS. THE MAIN REASON FOR REVISION IS ASEPTIC LOOSENING. UNSURE IF THERE'S INFECTION THERE. CULTURES HAS BEEN NEGATIVE BUT HAS ELEVATED ESR AND CRP. AS A RESULT, WILL CONSIDER OPEN CULTURE 1ST AND IF NEGATIVE, WILL GO AHEAD WITH REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19388791 ↗