INFINITY™ EVERLAST™ 33681108Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889797074360), received between Apr 20, 2023 and May 28, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Insufficient Device Problem Information

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO POTENTIAL GUTTER ISSUES AND TIBIAL CONCERNS.

  Patient problems: Insufficient Information

  MAUDE report 25323456 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO HARDWARE FAILURE AND PAIN.

  Patient problems: Pain

  MAUDE report 23864012 ↗
• 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 23576110 ↗
• InjuryNov 17, 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) 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. (PI #2).

  Patient problems: Arthritis; Pain

  MAUDE report 23572873 ↗
• 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 23536385 ↗
• InjurySep 17, 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 MAY REQUIRE A REVISION SURGERY DUE TO POSSIBLE IMPLANT LOOSENING, WITH CONSIDERATION FOR A GUTTER AND POLY SWAP.

  Patient problems: Inadequate Osseointegration; Joint Impingement

  MAUDE report 23077186 ↗
• InjuryDec 11, 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. IN ADDITION, THERE IS ALSO SUSPECTED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18300620 ↗
• 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 18022634 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2023 WITH THE COMPLAINT OF INCREASED PAIN AND SWELLING IN ANKLE FOLLOWING THE USE OF DYNASPLINT FOR 2 DAYS. ADDITIONALLY, THERE WAS PURULENT DRAINAGE COMING FROM THE PATIENT'S ANTERIOR ANKLE WOUND AND SURROUNDING ERYTHEMA. THERE IS OBVIOUS OPENING OF THE SURGICAL WOUND AND SUSPECTED DEEP INFECTION. THE PATIENT NEEDS TO RETURN TO OR FOR I&D AND POLY EXCHANGE. THE PATIENT WAS GIVEN MEDICATIONS AND UNDERWENT A REVISION SURGERY OF THE POLYETHYLENE INSERT ON (B)(6) 2023.

  Patient problems: Implant Pain; Post Operative Wound Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 17725938 ↗
• 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 17410432 ↗
• InjuryApr 20, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THERE IS AN UPCOMING REVISION OF THE INFINITY TOTAL ANKLE REPLACEMENT. BOTH TIBIA AND TALUS REQUIRE REVISION AS THEY ARE LOOSE.

  Patient problems: Cyst(s); Inadequate Osseointegration; Insufficient Information

  MAUDE report 16782289 ↗