INFINITY™ EVERLAST™ 33683206Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889797074476), received between Feb 24, 2023 and Feb 12, 2026 — classified as 15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) STUDY: (B)(6). PATIENT SENT A MESSAGE TO THE CLINICAL TEAM ON 24FEB2023 REPORTING INABILITY TO DO HEEL LIFTS DUE TO LACK OF STRENGTH. SHE ALSO REPORTED NUMBNESS THAT RUNS THE LENGTH OF HER SHIN BONE ON THE FRONT OF HER LEG. AN EMG WAS SCHEDULED (B)(6) 2023, DUE TO PATIENT TRAVEL BEFOREHAND. EMG SHOWED EVIDENCE OF LEFT SCIATIC MONONEUROPATHY AFFECTING THE TIBIAL FASCICLES MORE THAN THE PERONEAL FASCICLES, LOCALIZED TO THE POPLITEAL FOSSA. PATIENT HAD INITIAL VISIT WITH PERIPHERAL NERVE INJURY CLINIC ON 17MAY2023. PATIENT WILL CONTINUE PHYSICAL THERAPY TO IMPROVE SYMPTOMS, MEDICATION AND INTERVENTION WERE NOT RECOMMENDED. UPDATE 16 JAN 2026: 30-OCT-2025: ¿NUMBNESS AND TINGLING IN THE LEFT LEG AND FOOT HAVE IMPROVED SINCE THE LAST VISIT. SYMPTOMS ARE LIKELY DUE TO A NERVE INJURY SUSTAINED DURING THE ANKLE REPLACEMENT SURGERY THAT IS PERMANENT, THUS CLASSIFYING IT A SERIOUS ADVERSE EVENT. THE NERVE INJURY IS FOCAL, PRIMARILY AFFECTING ONE NERVE ROOT, CONTRIBUTING TO PAIN AND STIFFNESS. THE NEUROGENIC ELEMENT IS BETTER THAN BEFORE BUT NOT PERFECT. DID THIS ADVERSE EVENT MEET THE CRITERIA OF A SERIOUS ADVERSE EV

  Patient problems: Neuropathy; Numbness

  MAUDE report 24323845 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY SWAP WITH GUTTER DEBRIDEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23927424 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  SUBJECT: (B)(4). INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6) 2022: PATIENT REPORTS PAIN IN LEFT ANKLE. PATIENT HAS SOME TENDERNESS SUB FIBULAR IMPINGEMENT AREA. CT PROPHECY PROTOCOL DONE TO ENSURE THAT IMPLANT IS NOT LOOSE. (B)(6) 2023: SURGICAL INTERVENTION INVOLVING EXPLANT OF DEVICE DUE TO ASEPTIC LOOSENING. PATIENT DISCHARGED (B)(6) 2023.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 23536169 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). STUDY: STRYKER ITAR-2 - INFINITY WITH ADAPTIS. SUBJECT HAS INTERMITTENT SWELLING STILL PRESENT.

  Patient problems: Swelling/ Edema

  MAUDE report 22961237 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). STUDY: STRYKER ITAR-2 - INFINITY WITH ADAPTIS. SUBJECT HAS SOME NEW NUMBNESS ALONG THE PLANTAR DISTAL TOES.

  Patient problems: Numbness

  MAUDE report 22961235 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: 300-007 - INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6) 2021: WORSENING REDNESS AROUND INCISION. DELAYED WOUND HEALING. NO EVIDENCE OF DEEP INFECTION, HOLD MOTION, CONTINUE SOAP AND WATER WASH, BACTRIM ANTIBIOTIC PRESCRIBED. (B)(6) 2021: WORSENING. SMALL AREA OF WOUND DEHISCENCE WITH MILD EXUDATE MILD ERYTHEMA. NO PURULENT DRAINAGE, NO SIGNS OF DEEP INFECTION. CONTINUE WET-TO-DRY DRESSINGS OVER SMALL AREA OF WOUND DEHISCENCE. (B)(6) 2021: NO CHANGE. WOUND DEBRIDED IN OFFICE. HOLD MOTION FOR ANOTHER WEEK. (B)(6) 2021: IMPROVING. WOUND APPEARS LESS IRRITATED, CONTINUE WET-TO-DRY DRESSINGS, REFERRAL TO WOUND CARE. (B)(6) 2021: IMPROVING. GRANULATION TISSUE BED LOOKS EXCEPTIONAL. WOUND APPEARS TO BE RESPONDING EXCELLENT. BACTRIM TO BE CAUTIOUS. (B)(6) 2021: IMPROVING. INCISION HEALING. MILD WOUND DEHISCENCE. MUCH IMPROVED. CONTINUW WITH WOUND CARE. (B)(6) 2021: IMPROVING. INCISION HEALING WELL. MUCH IMPROVED. (B)(6) 2021: RESOLVED. INCISION HEALED. NO DRAINAGE. NO SIGNS OF INFECTION."

  Patient problems: Erythema; Wound Dehiscence

  MAUDE report 21468380 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY AND THE IMPLANT WAS REPLACED WITH A CEMENT SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 19254915 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A A DEVICE EXPLANT SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 18797947 ↗
• InjuryDec 15, 2023Adverse 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 OF THE POLY DUE TO PAIN AND POSSIBLE IMPINGEMENT ISSUE.

  Patient problems: Implant Pain

  MAUDE report 18340417 ↗
• InjuryOct 23, 2023Material Fragmentation; Naturally Worn; Material Fragmentation; Naturally Worn

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO SUSPECTED INFECTION. UPON TESTING IT WAS NOTED THAT THERE WAS NO INFECTION BUT THERE WAS POLYETHYLENE DEBRIS. THE PATIENT RECEIVED A CEMENT SPACER.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 17983989 ↗
• InjuryOct 20, 2023Adverse 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. UPON FOLLOW UP VISITS POST PROCEDURE THE FOLLOWING WAS NOTED ON (B)(6) 2021: MILD BLISTERING FROM SWELLING. NO DRAINAGE OR TUNNELING. ON (B)(6) 2021: STILL HAS BLISTERING. ON (B)(6) 2021:WOUND HEALING. SOME ESCHAR IN MIDPORTION. NO TUNNELING. NO DRAINAGE. ON (B)(6) 2021: WET TO DRY DRESSING, START ROM AND POSSIBLY WEIGHT BEARING. THE PATIENT HAD DELAYED HEALING OF WOUND BUT SUPERFICIAL IN NATURE. NO SIGNS OF INFECTION OR DEEP TUNNELING. NO DRAINAGE. MINIMAL SWELLING. ON (B)(6) 2021: MILD WOUND DEHISCENCE WITH ESCHAR, NO EVIDENCE OF DEEP INFECTION OR TUNNELING. ON (B)(6) 2021: WOUND SEEMS TO BE GRANULATING VERY WELL. SMALLER NATURE TODAY FROM STAND POINT AS WELL AS DEPTH. NO DRAINAGE, NO SIGNS OF DEEP INFECTION, NO SIGNS OF SUPERFICIAL INFECTION. WOUND VAC PLACED. REMAIN WITH WOUND CARE. ON (B)(6) 2021: INCISION HEALING WELL. GRANULATING TISSUE. WOUND MUCH SMALLER, NO TUNNELING, NO SIGNS OF DEEP/SUPERFICIAL INFECTION. ON (B)(6) 2021: WOUND LOOKS SUBSTANTIALLY BETTER. INCISIONS HEALING WELL. GRANULATING TISSUE. WOUND MUCH SMALLER. NO TUNNELING, NO SIGNS OF DEEP INFECTION. MINIMAL SWELLING. ON (B)(6) 2021: WOUND TOT

  Patient problems: Blister; Impaired Healing; Swelling/ Edema; Wound Dehiscence

  MAUDE report 17980896 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN, DRAINAGE AND SWELLING. THE PATIENT HAD SEPTIC ARTHRITIS IN THE ANKLE DUE TO AN UNSPECIFIED ORGANISM. THE IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED.

  Patient problems: Fluid Discharge; Implant Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17966212 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED DURING A FOLLOW UP VISIT WITH INFECTION. ASPIRATION CULTURES WERE POSITIVE FOR INFECTION AND IMPLANT REMOVAL WITH WASH OUT PERFORMED. ANTIBIOTIC CEMENT SPACER WAS PLACED AND PATIENT WAS PLACED ON ANTIBIOTIC COURSE. REVISION IS PLANNED FOR SOMETIME IN (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 17326935 ↗
• InjuryApr 10, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THERE IS AN UPCOMING REVISION SURGERY. THE REASON FOR THE REVISION IS PAINFUL LOOSENING HARDWARE. REVISION HAS NOT HAPPENED YET, STILL IN THE PLANNING STAGES WITH PROPHECY BUT IT IS LIKELY EVERYTHING (ALL THE HARDWARE) WILL COME OUT. NO MEDICAL INTERVENTION AND/OR SURGICAL INTERVENTION HAS OCCURRED WITH THE PATIENT SINCE THE PRIMARY TAR SURGERY.

  Patient problems: Implant Pain

  MAUDE report 16710420 ↗
• InjuryFeb 24, 2023Adverse 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 WOUND BREAK DOWN AND PAIN. UPON A CT SCAN IT LOOKED LIKE THERE WAS LOOSENING BUT ONCE IT WAS CLEANED OUT, THE IMPLANT WAS STABLE ASEPTIC, CULTURED DURING WASH OUT AND NOTHING GREW.

  Patient problems: Implant Pain; Wound Dehiscence

  MAUDE report 16439558 ↗