INFINITY™ EVERLAST™ 33684406Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889797074599), received between Dec 9, 2021 and May 19, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Insufficient 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 25222115 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "FATIGUE FRACTURE OF THE MEDIAL MALLEOLUS AFTER TOTAL KNEE REPLACEMENT ON (b)(6) 2025, DIAGNOSED ON (b)(6), 2026. I (THE PATIENT) HAVE SUFFERED A FATIGUE FRACTURE ON THE RIGHT INNER ANKLE. I WOULD LIKE TO KNOW WHETHER THIS COMPLICATION IS KNOWN. FURTHERMORE, IN THE 13TH POSTOPERATIVE WEEK, I NOTICED SPONTANEOUS NECROSIS IN THE SCAR AREA.NOTE: AS OF (b)(6) 2026, THE ONLY X-RAYS AND IMPLANT INFORMATION PROVIDED ARE FOR AN INFINITY ANKLE."

  Patient problems: Limb Fracture; Necrosis

  MAUDE report 24532258 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY WITH ADAPTIS ANKLE (ITAR-2) STUDY. ANKLE IMPINGEMENT SYNDROME. PERSISTENT PAIN. PHYSICIANS NOTE DOCUMENTS LIMITED DORSIFLEXION AND ANTERIOR IMPINGEMENT PAIN. PLAN FOR ARTHROSCOPIC DEBRIDEMENT ANTERIORLY TO HELP WITH PAIN AND MAY IMPROVE MOTION ALSO. OPERATION PERFORMED 2(B)(6) 2021: PATIENT UNDERWENT REOPERATION FOR RIGHT ANKLE ARTHROSCOPIC DEBRIDEMENT. AE UPDATE 11-JAN-2022: PATIENT REPORTS ARE IMPROVING. DIRECTED TO WEIGHT BEAR AS TOLERATED AND AGGRESSIVE PHYSICAL THERAPY WORKING ON RANGE OF MOTION RECOMMENDED.

  Patient problems: Joint Impingement; Pain

  MAUDE report 23402222 ↗
• 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: WOUND DEHISCENCE. DELAYED WOUND HEALING. SMALL AREA OF WOUND DEHISCENCE NOTED IN THE FLAP AREA OF THE INCISION AT THE 3 WEEK POST OP VISIT. RECOMMENDATIONS INCLUDED XEROFORM DRY DRESSING CHANGES DAILY, WASH WITH SOAP AND WATER, CONTINUE NONWEIGHT BEARING, AND FOLLOW-UP IN 1 WEEK. (B)(6) 2022: IMPROVING. INCISION IS HEALING WELL. 1 SMALL AREA OF ESCHAR. FOLLOW-UP 2-3 WEEKS. (B)(6) 2022: WORSENING. REDNESS AROUND INCISION SITE WITH NEW DRAINAGE. RECOMMEND IRRIGATION AND DEBRIDEMENT WITH IV ANTIBIOTICS AND REVISION WITH POLY EXCHANGE. EVERLAST POLY WAS REMOVED AND DISCARDED. (B)(6) 2022: IMPROVING. (B)(6) 2022: IMPROVING. INCISION HEALING WELL. MEDIHONEY AND GAUZE DRESSING. DAILY DRESSING CHANGES. OKAY TO WASH WITH SOAP AND WATER. NONWEIGHT BEARING. HOME PT, VERY GENTLE ANKLE RANGE OF MOTION. (B)(6) 2022: IMPROVING. INCISION HEALING WELL. INCISION HAS ALMOST FULLY HEALED, JUST 1 PINPOINT AREA THAT HE CAN CONTINUE MEDIHONEY AND GAUZE IN THE NEXT FEW DAYS UNTIL THIS HEALS UP. GRADUAL PROGRESSION TO FULL WEIGHTBEARING IN THE TALL BOOT. COMMENCE PHYSICAL THERAPY. (B)(6) 2022: IMPR

  Patient problems: Inflammation; Wound Dehiscence

  MAUDE report 20426069 ↗
• InjuryMay 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THERE IS AN UPCOMING REVISION SURGERY TO REVISE BOTH TIBIA AND TALUS. THE SURGEONS WANTS TO USE THE INVISION, LIKELY SOME TIBIA BASE BUILD UP AND AN INBONE 2 TIBIAL STEM THAT EXTENDS ENOUGH UP THAT FEELS SECURE. ALSO WILL REVISE THE TALUS COMPONENT AND DROP DOWN A SIZE ON THE TALUS FOR FEEL THE WIDTH OF THE ORIGINAL ONE PUT IN MAY HAVE BEEN A BIT WIDE FOR THE LATERAL GUTTER. ORIGINAL WAS A SIZE 4 INFINITY TIBIA AND SIZE 4 INFINITY CHAMFER TALUS

  Patient problems: Insufficient Information

  MAUDE report 16898609 ↗
• InjurySep 22, 2022Adverse 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) 2022, CONCERNED ABOUT AN INFECTION OF THE ANTERIOR ANKLE INCISION. THE PHYSICIAN NOTED A SURGICAL WOUND COMPLICATED BY DEHISCENCE, DRAINAGE OF PURULENT FLUID, SWELLING, AND ERYTHEMA. FOLLOWING A RIGHT ANKLE WOUND IRRIGATION AND DEBRIDEMENT ON (B)(6) 2022, THE PHYSICIAN NOTED NO EVIDENCE OF A DEEP INFECTION. ROUTINE CULTURE FINAL REPORT ON (B)(6) 2022, CONFIRMED A STAPHYLOCOCCUS AUREUS INFECTION. PATIENT WAS PRESCRIBED KEFLEX.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema; Wound Dehiscence

  MAUDE report 15463602 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN OFFICE EVALUATION IT WAS FOUND THAT THE PATIENT HAD MILD WOUND DEHISCENCE IN THE MID PORTION INCISIONAL AREA. MINIMAL SEROSANGUINEOUS DRAINAGE NOTED. THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE SURGEON TOOK MULTIPLE CULTURES, PERFORMED IRRIGATION DEBRIDEMENT OF THE WOUND AND SWAPPED OUT THE POLY. A NEGATIVE PRESSURE WOUND THERAPY WAS APPLIED OVER SMALL AREA OF WOUND DEHISCENCE.

  Patient problems: Wound Dehiscence

  MAUDE report 12971009 ↗