INFINITY ADAPTIS 33680003Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00889797069656), received between Apr 19, 2022 and Apr 21, 2026 — classified as 36 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (11 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY WITH ADAPTIS TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) STUDY. SUBJECT CALLED THE SURGEON TO REPORT CONTINUED LEFT ANKLE PAIN AND ASKED TO PROCEED WITH A MEDIAL GUTTER DEBRIDEMENT. THE SURGEON CONSIDERS THE MEDIAL GUTTER IMPINGEMENT A PROCEDURE-RELATED AE. SURGERY ON STUDY ANKLE. UPDATE ON 15 APR 2026: (B)(6) 2025: SUBJECT CALLED THE SURGEON TO REPORT CONTINUED LEFT ANKLE PAIN AND ASKED TO PROCEED WITH A MEDIAL GUTTER DEBRIDEMENT. (B)(6) 2025 ¿ SURGERY: LEFT MEDIAL TIBIAL AND MEDIAL TALUS EXOSTOSIS EXCISION FROM THE MEDIAL GUTTER OF THE ANKLE. NO PRODUCTS WERE REMOVED DURING THIS PROCEDURE.

  Patient problems: Joint Impingement; Pain

  MAUDE report 24936001 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) STUDY: SUBJECT (B)(6). PATIENT SENT A MESSAGE TO THE CLINICAL TEAM ON (B)(6) 2023 REPORTING INABILITY TO DO HEEL LIFTS DUE TO LACK OF STRENGTH. SHE ALSO REPORTED NUMBNESS THAT RUNS THE LENGTH OF HER SHIN BONE ON THE FRONT OF HER LEG. AN EMG WAS SCHEDULED (B)(6) 2023, DUE TO PATIENT TRAVEL BEFOREHAND. EMG SHOWED EVIDENCE OF LEFT SCIATIC MONONEUROPATHY AFFECTING THE TIBIAL FASCICLES MORE THAN THE PERONEAL FASCICLES, LOCALIZED TO THE POPLITEAL FOSSA. PATIENT HAD INITIAL VISIT WITH PERIPHERAL NERVE INJURY CLINIC ON (B)(6) 2023. PATIENT WILL CONTINUE PHYSICAL THERAPY TO IMPROVE SYMPTOMS, MEDICATION AND INTERVENTION WERE NOT RECOMMENDED. UPDATE 16 JAN 2026: 30-OCT-2025 ¿NUMBNESS AND TINGLING IN THE LEFT LEG AND FOOT HAVE IMPROVED SINCE THE LAST VISIT. SYMPTOMS ARE LIKELY DUE TO A NERVE INJURY SUSTAINED DURING THE ANKLE REPLACEMENT SURGERY THAT IS PERMANENT, THUS CLASSIFYING IT A SERIOUS ADVERSE EVENT. THE NERVE INJURY IS FOCAL, PRIMARILY AFFECTING ONE NERVE ROOT, CONTRIBUTING TO PAIN AND STIFFNESS. THE NEUROGENIC ELEMENT IS BETTER THAN BEFORE BUT NOT PERFECT. DID THIS ADVERSE EVENT MEET THE CRITERIA OF A SERIOUS

  Patient problems: Neuropathy; Numbness

  MAUDE report 24323842 ↗
• InjuryJan 26, 2026Adverse 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 DUE TO PERSISTENT PAIN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 24184409 ↗
• InjuryDec 9, 2025Device Dislodged or Dislocated; Implant subsidence; Device Dislodged or Dislocated; Implant subsidence

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT FRACTURED THE TIBIA AND THE TIBIA COMPONENT IS NOW DISPLACED DORSALLY AND INVOLVING THE TIBIA ANTERIOR AND MAY REQUIRE A REVISION SURGERY.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 23758447 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(4). INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6) 2024: PATIENT REPORTED PERSISTENT PAIN AND SWELLING. NO FURTHER INFORMATION (B)(6) 2024: PATIENT REPORTED PAIN WAS WORSENING. AE UPGRADED TO SAE AND PATIENT HAD THE FOLLOWING PROCEDURES PERFORMED: TARSAL TUNNEL RELEASE; RIGHT TENOSYNOVECTOMY FLEXOR HALLUCIS LONGUS RIGHT; EXCISION MEDIAL TALUS AND CALCANEUS OSTEOPHYTE RIGHT; BONE GRAFT MEDIAL MALLEOLAR CYST AND DEBRIDEMENT, MEDIAL ANKLE JOINT. (SEE ATTACHED OPERATIVE NOTES) (B)(6) 2024: PATIENT IMPROVING POST-OP BUT STILL EXPERIENCING ONGOING PERSISTENT PAIN IN SUBTALAR JOINT. STEROID INJECTION ADMINISTERED. (B)(6) 2025: MOST RECENT UPDATE STATES PATIENT REPORTS NO CHANGE AND STILL HAVING PAIN IN ANKLE JOINT AREA. ANOTHER STEROID INJECTION WAS ADMINISTERED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23536455 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). STRYKER ITAR-2 (INFINITY WITH ADAPTIS) STUDY. PERSISTENT PAIN. PT REPORTED HIS PAIN HAS BEEN GRADUALLY INCREASING OVER THE PAST 6 MONTHS. HE HAS PAIN WHEN AMBULATING. DENIES REST PAIN. DENIES FEVERS CURRENTLY. ENDORSES 6/10 PAIN, SHARP, DULL, CONSTANT WHEN WALKING.

  Patient problems: Pain

  MAUDE report 23535861 ↗
• InjuryOct 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 23361030 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). STRYKER ITAR-2 STUDY. NARRATIVE OF ADVERSE EVENT: PATIENT REPORTED FALLING OFF A CURB ON (B)(6) 2025, RESULTING IN A CLOSED FIBULA FRACTURE OF THE RIGHT ANKLE, A SMALL TENDON TEAR OF THE RIGHT ANKLE, AS WELL AS SELF-REPORTED PAIN/DISCOMFORT OF THE LEFT ANKLE (STUDY ANKLE). RIGHT ANKLE FRACTURE TREATMENT (NON-STUDY ANKLE): THE EMERGENCY ROOM MD PLACED THE PATIENT IN A WALKING BOOT X 1 WEEK, AND AFTER FOLLOW-UP WITH AN ORTHOPAEDIC MD, THE PATIENT WAS PLACED IN AN ANKLE BRACE X 2 WEEKS AND PRESCRIBED PHYSICAL THERAPY. THE PATIENT TOOK TYLENOL PRN. RIGHT ANKLE TENDON TEAR TREATMENT (NON-STUDY ANKLE): PATIENT RETURNED TO THE ORTHOPAEDIC MD 3 MONTHS POST-FRACTURE DIAGNOSIS COMPLAINING OF CONTINUED RIGHT ANKLE PAIN. MRI SHOWED A SMALL TENDON TEAR AND THE ORIGINAL PHYSICAL THERAPY SCRIPT WAS EXTENDED TO TREAT ASSOCIATED PAIN. LEFT ANKLE SELF-REPORTED PAIN TREATMENT (STUDY ANKLE): ORTHOPAEDIC MD RECOMMENDED PHYSICAL THERAPY TO HELP STRENGTHEN THE ANKLE AND REDUCE PAIN/DISCOMFORT. AE STATUS AS OF JULY 2, 2025: BOTH RIGHT AND LEFT ANKLE PAIN ARE IMPROVING, BUT THE PATIENT CONTINUES TO GO TO PHYSICAL THERAPY. PLANNED REASSESSMENT OF THIS AE (#6) AT 2 YEAR STUDY VISIT SCHEDULED

  Patient problems: Pain

  MAUDE report 23347470 ↗
• InjuryOct 7, 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 LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23237624 ↗
• InjuryAug 28, 2025Adverse 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 UNDERWENT A REVISION SURGERY WHERE A CEMENT SPACER WAS IMPLANTED. THE REASON FOR THE REVISION IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 22912505 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Implant subsidence; Adverse Event Without Identified Device or Use Problem; Implant subsidence

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR THE UPCOMING REVISION SURGERY. THE REASON FOR THE REVISION IS DUE TO STIFFNESS OF THE JOINT AND BONE OVERGROWTH NEAR THE IMPLANT.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 22904943 ↗
• InjuryMay 20, 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 22055763 ↗
• InjuryMay 15, 2025Migration; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE REVISION SURGERY DUE TO INCREASED PAIN AND THE RECEDING OF THE TIBIAL TRAY. THE DOCTOR NOTICED THE ISSUE WHEN THE PATIENT WAS GETTING X-RAYS. THE PATIENT WAS COMPLIANT WITH TO MOBILIZATION INSTRUCTIONS OF THE SURGEON. IT WAS REPORTED THAT THE PATIENT WAS HEALTHY WITH GOOD BONE QUALITY AND HAD INITIALLY PRESENTED WITH ANKLE ARTHRITIS.

  Patient problems: Implant Pain

  MAUDE report 22028595 ↗
• InjuryMay 7, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN DUE TO IMPLANT SIZE.

  Patient problems: Implant Pain; Pain

  MAUDE report 21980919 ↗
• 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 21071391 ↗
• InjuryDec 20, 2024Osseointegration 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 FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 20995182 ↗
• InjuryOct 10, 2024Osseointegration 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 SUBSIDENCE AND CYSTIC CHANGES.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 20416623 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT (B)(6). INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). PERSISTENT PAIN ((B)(6) 2024) PATIENT REPORTED WORSENING LEFT ANKLE PAIN S/P 1 YEAR TAR. SYMPTOMS STARTED AFTER COMPLETING FORMAL PHYSICAL THERAPY AROUND THE HOLIDAYS/ (B)(6) 2024. SURGEON ORDERED CT SCAN, RESULTS ARE PENDING. PERSISTENT SWELLING ((B)(6) 2024). PATIENT REPORTED WORSENING LEFT ANKLE SWELLING S/P 1 YEAR TAR. SYMPTOMS STARTED AFTER PATIENT COMPLETED FORMAL PHYSICAL THERAPY AROUND THE HOLIDAYS/JANUARY. SURGEON ORDERED A CT SCAN, RESULTS ARE PENDING.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 20240957 ↗
• InjuryAug 22, 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 FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT HAD THE ORIGINAL SURGERY ON (B)(6) 2022 BECAUSE THE PATIENT HAD A 18 DEGREES OF VARUS AND THE PATIENT IS COMPLAINING OF PAIN.

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 20032062 ↗
• InjuryJul 1, 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 BECAUSE THE PATIENT MEDIAL TIBIA SUBSIDED AND WENT INTO VALGUS. THE PATIENT HAS LOW PARATHYROID HORMONE LEVELS WHICH NEEDS TO BE OPTIMIZED BEFORE THE REVISION SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19651662 ↗
• InjuryJun 10, 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 WAS HAVING INCISION WOUND ISSUES AND UNDERWENT A DEVICE EXPLANT SURGERY. THE PATIENT RECEIVED A CEMENT SPACER.

  Patient problems: Wound Dehiscence

  MAUDE report 19499704 ↗
• InjuryMay 30, 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 ASEPTIC LOOSENING.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 19430841 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use 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 IMPLANTS DUE TO PAIN AND LUCENCY.

  Patient problems: Implant Pain

  MAUDE report 19305456 ↗
• InjuryApr 9, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A REVISION SURGERY OF BOTH THE TIBIAL AND TALAR COMPONENTS DUE TO ASEPTIC LOOSENING OCCURRING LESS THAN A YEAR AFTER IMPLANTATION. NO TRAUMA, NO ABNORMAL EVENT, NO EVIDENCE OF INFECTION. PATIENT HAS RHEUMATOID ARTHRITIS AND HISTORY OF FRACTURE MANY YEARS AGO.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 19076511 ↗
• InjuryFeb 16, 2024Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO A LOOSE/PAINFUL TIBIA IMPLANT. IF THEY SWITCH TO A STEMMED IMPLANT ON THE TIBIA THEN THE TALAR COMPONENT MUST ALSO BE REMOVED AS A RESULT.

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

  MAUDE report 18722440 ↗