INFINITY™ EVERLAST™ 33683208Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889797074483), received between Dec 20, 2022 and Apr 21, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• 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: ON (B)(6) 2025: SUBJECT CALLED THE SURGEON TO REPORT CONTINUED LEFT ANKLE PAIN AND ASKED TO PROCEED WITH A MEDIAL GUTTER DEBRIDEMENT. ON (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 24936004 ↗
• 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 23361054 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(4) STUDY: STRYKER ITAR-2 - INFINITY WITH ADAPTIS. SUBJECT HAS PERSISTENT PAIN IN HIS LEFT ANKLE.

  Patient problems: Pain

  MAUDE report 23001795 ↗
• InjuryAug 28, 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 THE UPCOMING REVISION SURGERY DUE TO SOME STIFFNESS OF THE JOINT AND SOME BONE OVERGROWTH NEAR THE IMPLANT SO NOT NECESSARILY IMPLANT FAILURE. THE SURGEON WANTS TO REVISE TO CLEAR OUT BONE, GET MORE SPACE AND MORE ARTICULATION.

  Patient problems: Extraskeletal ossification; Joint Impingement; Loss of Range of Motion

  MAUDE report 22912386 ↗
• 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 20854121 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: 400-006 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 20298709 ↗
• 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 20240931 ↗
• 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 19499710 ↗
• InjuryApr 13, 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 MAY REQUIRE A REVISION SURGERY DUE TO PAIN IN THE ANKLE.

  Patient problems: Implant Pain

  MAUDE report 19102770 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN. THE PHYSICIAN REPORTED THAT BASED ON THE CT SCANS THERE ARE PERI-IMPLANT FRACTURES AND THE TIBIAL TRAY APPEARS TO HAVE SHIFTED/SUBSIDED. IT WILL NEED TO BE REVISED AND IN ORDER TO ACCESS THAT, THE TALAR DOME IMPLANT WOULD NEED TO BE REVISED TOO. IT WAS NOTED THAT THE PATIENT OVERDID PHYSICALLY THAT MAY HAVE LED TO THE PAIN/LOOSENING AND MIGRATION OF THE IMPLANT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Limb Fracture

  MAUDE report 17232493 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. THE PATIENT PRESENTED WITH INFECTION AND UNDERWENT A REVISION PROCEDURE.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 16018970 ↗