INFINITY™ EVERLAST™ 33684408Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889797074605), received between Sep 26, 2024 and Jun 15, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Loss of Osseointegration; 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. IT WAS REPORTED: THE IMPLANTS WERE INITIALLY SIZED AND PLACED CORRECTLY, SECURED CORRECTLY WITH CEMENT BUT DID LOOSEN SLOWLY OVER THE TIMEFRAME AND BECAME MUCH MORE SYMPTOMATIC RECENTLY. THE EVENT APPEARS TO BE A STRAIGHTFORWARD CASE OF MECHANICAL LOOSENING AND SUBSEQUENT SUBSIDENCE".

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 25512609 ↗
• InjuryDec 10, 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 UNKNOWN REASONS AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 23770043 ↗
• InjurySep 25, 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 REVISION SURGERY MAY BE REQUIRED. A TOTAL ANKLE REPLACEMENT WITH A WRIGHT MEDICAL/STRYKER DEVICE WAS PREVIOUSLY PERFORMED FOR ARTHRITIS AND ANKLE PAIN. REPORTS INCLUDE SWELLING AND MEDIAL ANKLE PAIN, WITH IMAGING SUGGESTING A POSSIBLE MEDIAL MALLEOLUS STRESS FRACTURE AND POTENTIAL TIBIAL TRAY LOOSENING. NO REVISION HAS BEEN PERFORMED TO DATE. BONE QUALITY WAS DESCRIBED AS GOOD, AND COMPLIANCE WITH MOBILIZATION INSTRUCTIONS WAS NOTED, THOUGH A PHYSICALLY ACTIVE LIFESTYLE MAY HAVE CONTRIBUTED TO THE REPORTED SYMPTOMS.

  Patient problems: Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 23142671 ↗
• InjuryOct 11, 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: DORSAL FOOT NEURITIS. PERSISTENT NERVE PAIN. NERVE TINGLING & NUMBNESS-DORSAL FOOT. (B)(6) 2023: IMPROVING. HEALING AND PROGRESSING WELL. TREATMENT UPDATED TO INCLUDE ORTHOTICS. (B)(6) 2023: ORTHOTICS, ULTRASOUND GUIDED INJECTION. (B)(6) 2023: IMPROVING. SIGNIFICANT RELIEF AFTER ULTRASOUND INJECTION."

  Patient problems: Implant Pain; Numbness

  MAUDE report 20426081 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: 700-001 INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). PATIENT PRESENTED TO THE CLINIC FOR A POSTOP FOLLOW UP APPOINTMENT ON (B)(6) 2022 (3 MONTHS S/P LEFT TAR PROCEDURE), CONCERNED ABOUT CONTINUED SIGNIFICANT SWELLING AND DISCOMFORT. THE SURGEON ORDERED AN ULTRASOUND TO RULE OUT A LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) ON (B)(6) 2022. ULTRASOUND REPORT FOUND NO EVIDENCE OF A DVT. PATIENT IS SCHEDULED FOR ANOTHER POSTOP VISIT ON (B)(6) 2022 (6 MONTHS S/P LEFT TAR PROCEDURE). UPDATE 08 DEC 2022: PATIENT REPORTED SWELLING HAS IMPROVED."

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 20307751 ↗