INFINITY ADAPTIS 33680001Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00889797069632), received between Feb 2, 2023 and Dec 30, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryDec 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. IMAGING SUGGESTS LOOSENING OF THE TIBIAL COMPONENT ONLY, WITH CONSIDERATION FOR A STEMMED TIBIAL REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23927426 ↗
• InjuryDec 16, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Implant subsidence; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Implant subsidence

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO HARDWARE FAILURE AND SUBSEQUENT LOOSENING AND SUBSIDENCE OF THE TIBIAL COMPONENT.

  Patient problems: Inadequate Osseointegration; Joint Dislocation; Pain

  MAUDE report 23820470 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6) 2024: PATIENT IMPROVING 4 WEEKS POST OP AND SITE IS HEALING. (B)(6) 2024: MOST RECENT UPDATE STATES PATIENT REPORTS PAIN IS WORSENING. ( PI #3).

  Patient problems: Pain

  MAUDE report 23574498 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6) 2023: PATIENT REPORTED PAIN WAS WORSENING. AE UPGRADED TO SAE AND PATIENT SCHEDULED FOR BONE GRAFT FIXATION OF THE CALCANEUS ON THE LEFT FOOT. (PI #2) (B)(6) 2024: UNDERWENT SURGICAL INTERVENTION FOR ARTHROTOMY OF ANKLE JOINT WITH DEBRIDEMENT OF ARTHRITIS TO REMOVE LOOSE BODY LATERAL GUTTER, LEFT; PARTIAL EXCISION DISTAL FIBULA FOR DECOMPRESSION; MEDIAL DISPLACEMENT CALCANEAL OSTEOTOMY (SEE ATTACHED OPERATIVE NOTES). (PI #2).

  Patient problems: Arthritis; Pain

  MAUDE report 23572566 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6). 2022: PATIENT REPORTED PERSISTENT SUBTALAR JOINT PAIN FROM ARTHRITIS ACCOMPANIED BY STIFFNESS AND SWELLING. PATIENT WAS TREATED WITH A STEROID INJECTION AND THIS WAS NOT CONSIDERED AN SAE AT THE TIME. (PI #1). (B)(6). 2023: SURGICAL INTERVENTION FOR ARTHROTOMY W DEBRIDEMENT & LOOSE BODY REMOVAL; DISTAL FIBULAR DECOMP; MEDIAL DISPLACEMENT CALCANEAL OSTEOTOMY. (PI #1).

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 23536367 ↗
• InjuryApr 1, 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 21748609 ↗
• InjuryDec 16, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  REPORTER CALLED TO INFORM THE FDA THAT A STRYKER RIGHT ANKLE IMPLANT THAT SHE RECEIVED IN 2022 HAS FAILED. IMPLANT FAILURE WAS CONFIRMED WITH A COMPUTED TOMOGRAPHY (CT) WHERE, THE DEVICE HAS BEEN SHOWN TO HAVE SEPARATED AND COME APART. REPORTER STATED THAT SINCE HAVING THE IMPLANT, SHE HAS BEEN VERY SICK AND BELIEVES SHE MAY BE HAVING A REACTION TO THE IMPLANT. PRESENTLY, HER RIGHT ANKLE HAS MASSIVE EDEMA THAT CAUSES HER LEG TO SWELL. ADDITIONALLY, THERE IS SHARP PAIN AND A CONTINUOUS BURNING SENSATION AT THE IMPLANT SITE. SHE HAS AN APPOINTMENT TO GET A BIOPSY ON THE (B)(6) 2024 TO RULE OUT INFECTION.

  Patient problems: Burning Sensation; Failure of Implant; Implant Pain; Swelling/ Edema

  MAUDE report 20946447 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: 200-002 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 20426071 ↗
• InjurySep 27, 2024Insufficient 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 20326719 ↗
• InjuryJul 9, 2024Break; Fracture; Osseointegration Problem; Break; Fracture; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A REVISION SURGERY BECAUSE THE TIBIAL IMPLANT'S POSTERIOR PEG BROKE OFF. IT WAS UNKNOWN IF THE BREAK HAPPENED DURING THE REMOVAL OF IMPLANTS OR IF IT WAS COMPROMISED PRIOR AND REASON FOR IMPLANT FAILURE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19707309 ↗
• InjuryJul 3, 2024Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration

  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 19670889 ↗
• InjuryFeb 29, 2024Osseointegration Problem; Insufficient Device Problem Information; Migration; Osseointegration Problem; Insufficient Device Problem Information; Migration

  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); Inadequate Osseointegration; Insufficient Information

  MAUDE report 18813218 ↗
• InjuryFeb 22, 2024Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REMOVAL SURGERY OF THE CURRENT TALAR IMPLANT DUE TO EARLY COLLAPSE OF THE TIBIAL SIDE WITHOUT TRAUMA. THERE IS A FRACTURE PRESENT IN THE TIBIA. THE PHYSICIAN REPORTED THAT THE PATIENT WILL NEED INTRAMEDULLARY FIXATION.

  Patient problems: Inadequate Osseointegration; Joint Dislocation; Limb Fracture

  MAUDE report 18763889 ↗
• InjuryDec 28, 2023Loss of Osseointegration; Osseointegration Problem; Migration; Loss of Osseointegration; Osseointegration Problem; Migration

  AS REPORTED: "SUBSIDENCE OF THE TIBIAL COMPONENT SEEN ON IN OFFICE X-RAY. PATIENT WAS SENT FOR CT SCAN FOR FURTHER EVALUATION. ACTIONS TAKEN: ORAL ANTIBIOTICS, DOUBLE UPRIGHT BRACE LOCKED IN NEUTRAL."

  Patient problems: Inadequate Osseointegration

  MAUDE report 18415759 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A REPORT INDICATING THE NEED FOR A REVISION FOR REASONS CURRENTLY UNKNOWN. THE PLAN IS TO PROCEED WITH THE INVISION CASE IN THE NEAR FUTURE. TALAR SUBSIDENCE IS NOTED AS AN ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 18297684 ↗
• InjuryNov 22, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH LUCENCY AROUND TIBIAL HARDWARE AND CONCERN FOR HARDWARE MALFUNCTION. THE NURSE PRACTITIONER REQUESTED A CT SCAN FROM THE DIGITAL STRYKER PROPHECY TEAM INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY. THE PATIENT IS TREATED WITH MEDICATION (UNKNOWN), CUSHIONED ATHLETIC SHOE, POWER STEP ARCH SUPPORT, ICE THERAPY, CRYOTHERAPY AND VOLTAREN GEL AND BRACE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18196616 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DELAYED WOUND HEALING AT ANTERIOR ANKLE INCISION. TREATMENT INCLUDES ORAL ANTIBIOTICS AND KEEPING INCISION COVERED AND DRY. ON (B)(6) 2023, THERE WAS SLIGHT IMPROVEMENT OF THE INCISION SINCE PREVIOUS VISIT, HOWEVER, DELAYED HEALING WAS STILL PRESENT. ON (B)(6) 2023, IT WAS NOTED THAT THERE WAS DELAYED WOUND HEALING IMPROVING WITH OUTPATIENT WOUND CARE.

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 18022783 ↗
• InjuryOct 17, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH PAIN. UPON X-RAYS IT WAS NOTED THAT THE TIBIAL COMPONENT WAS LOOSE. THE PATIENT WILL BE UNDERGOING A REVISION SURGERY TO USE A STEMMED IMPLANT TO CORRECT THE LOOSENING. THE PHYSICIAN DEFINITELY PLANS ON REVISING THE TIBIAL COMPONENT AND WILL LIKELY NEED TO REVISE THE TALAR COMPONENT AND WELL.

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

  MAUDE report 17953984 ↗
• InjuryAug 23, 2023Migration; 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 SUSPECTED SUBSIDENCE. IT WAS ALSO REPORTED THAT THE PATIENT CONTINUES TO HAVE PAIN, DISCOMFORT AND SWELLING.

  Patient problems: Discomfort; Implant Pain; Swelling/ Edema

  MAUDE report 17606512 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A REPORT THAT THERE IS AN UPCOMING REVISION SURGERY DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17410436 ↗
• InjuryFeb 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. THE TIBIAL COMPONENT SUBSIDED INTO ANTERIOR TIBIAL BONE. PATIENT WAS TESTED MULTIPLE TIMES FOR INFECTION. NO PRESENCE DETECTED. TIBIAL, TALAR, AND POLY IMPLANT WERE EXPLANTED. NO REMARKABLE PATIENT CIRCUMSTANCES INVOLVED. THE PATIENT WAS REVISED.

  Patient problems: Insufficient Information

  MAUDE report 16282697 ↗