INFINITY™ EVERLAST™ 33683306Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889797074513), received between Feb 8, 2022 and Nov 12, 2025 — classified as 8 injuries.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). STRYKER ITAR-2 (INFINITY WITH ADAPTIS) STUDY PERSISTENT PAIN. PT REPORTED HIS PAIN HAS BEEN GRADUALLY INCREASING OVER THE PAST 6 MONTHS. HE HAS PAIN WHEN AMBULATING. DENIES REST PAIN. DENIES FEVERS CURRENTLY. ENDORSES 6/10 PAIN, SHARP, DULL, CONSTANT WHEN WALKING.

  Patient problems: Pain

  MAUDE report 23535930 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(4) INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). 25 AUG 2022: SURGICAL INTERVENTION. MULTIPLE INJURIES TO STUDY ANKLE REQUIRING SURGICAL INTERVENTION. PARTIAL EXCISION OF FIBULA FOR OSTEOMYELITIS TRANSFER OF ADJACENT TISSUE. THIS EVENT IS CAPTURED UNDER STRYKER REFERENCE #'S (B)(4). UPDATE 01 SEP 2022: NO CHANGE. SUTURES REMAIN, DRY DRESSING APPLIED. WALKING BOOT CONTINUED. WEIGHT-BEAR FOR TOLERATED IN THE WALKING BOOT. UPDATE 05 OCT 2022: WORSENING. PATIENTS ENTIRE ANKLE JOINT IS INFECTED SUBSEQUENT FROM SEEDING POSTEROLATERAL. PATIENT NOTED SWELLING AND CHILLS. WILL DO CULTURES IMPLANT REMOVAL IRRIGATION DEBRIDEMENT, ANTIBIOTIC SPACER, AND ADMISSION WITH IV ANTIBIOTICS. UPDATE 11 OCT 2022: SURGICAL INTERVENTION DUE TO DEEP INFECTION. REOPERATION WITH REMOVAL OF TIBIAL AND/OR TALAR IMPLANTED COMPONENTS. THIS EVENT IS CAPTURED THIS RECORD."

  Patient problems: Bacterial Infection; Swelling/ Edema

  MAUDE report 21572308 ↗
• InjuryOct 9, 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: DROPFOOT. PATIENT SEEN ON (B)(6) 2022, FOR FOLLOW UP AND TO CONSIDER LEFT LOWER EXTREMITY NERVE CONDUCTION STUDY/EMG ORDERED TO EVALUATE DROP FOOT IF NOT IMPROVED BY NEXT VISIT. PATIENT STATED HE NOTICED THIS EVER SINCE COMING OUT OF CAST AND STARTING ANKLE RANGE OF MOTION EXERCISES AT HOME WHEN HE CANNOT ACTIVELY BRING HIS FOOT UP. (B)(6) 2022: IMPROVING. PATIENT IS SHOWING SOME ELEMENT OF FIRING DORSIFLEXORS, NO EMG NERVE CONDUCTION STUDY AT THIS TIME. MAY EVENTUALLY REQUIRE EMG NERVE CONDUCTION STUDY."

  Patient problems: Loss of Range of Motion; Nerve Damage

  MAUDE report 20407954 ↗
• InjuryJun 30, 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 NERVE PAIN AT THE RIGHT ANKLE. THE TREATMENT INVOLVED THE EFFECTED LEG BEING PLACED IN SHORT LEG CAST, ICE, ELEVATE. OVERALL, PATIENT IS HEALING AND DOING WELL POST-OPERATIVELY. TREATMENT INCLUDED MEDICATION AND INCREASED ACTIVITY. HEALING AND PROGRESSING WELL POSTOPERATIVELY. NERVE PAIN SHOULD CONTINUE TO IMPROVE. TREATMENT INCLUDED MEDICATION AND VISCOSE PAD FOR SHOE.

  Patient problems: Implant Pain; Nerve Damage

  MAUDE report 17241429 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED FROM WOUND CARE WHO EXPRESSED CONCERN OVER A WORSENING WOUND ON HIS ANTERIOR ANKLE. THE PATIENT UNFORTUNATELY HAS A NON-HEALING WOUND OVER THEIR ANTERIOR ANKLE WHICH PROBES DOWN TO BONE. GIVEN THE LARGE WOUND AND LIKELY EXPOSED PROSTHESIS, THE PATIENT NEEDS TO RETURN TO OR FOR I&D AND POLY EXCHANGE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 16765799 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER PATIENT UNDERWENT A DEBRIDEMENT AND IRRIGATION WITH A POLY SWAP, THE PATIENTS CONDITION IMPROVED. HOWEVER, A COUPLE OF WEEKS LATER THE PATIENT WORSENED AND HAD INCOMPLETE HEALING OF THE TENDON EXPOSURE. IRRIGATION DEBRIDEMENT OF THE SUPERFICIAL SKIN. IF IT APPEARED TO BE DEEPLY INFECTED AND A REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANTS AND INSERT AN ANTIBIOTIC IMPLANT ALONG WITH A WOUND VAC AND SYNOVECTOMY OF EXTENSOR TENDON.

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 13501979 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POSTOPERATIVE WOUND DEHISCENCE IN A SMALL AREA WITH NO DRAINAGE. THE PATIENT WAS ADVISED TO WASH THE AREA WITH SOAP AND WATER AND MAINTAIN A DRY DRESSING APPLIED TO WOUND DEHISCENCE. EIGHT DAYS LATER IT WAS FOUND THAT THE AREA WAS WORSENING AND INSPECTION FOUND MODERATE ERYTHEMA WITH PURULENT DRAINAGE. THERE WAS ALSO MODERATE SWELLING. PALPATION TENDERNESS AROUND THE INCISIONAL AREA. PATIENT IS DIGRESSING WITH WORSENING PAIN REDNESS AND DRAINAGE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR LEFT ANKLE REVISION WITH IRRIGATION DEBRIDEMENT AND A POLYETHYLENE EXCHANGE.

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

  MAUDE report 13501845 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AND INFINITY SYSTEM IMPLANTED. THE ANKLE AREA BECAME INFECTED. THE PHYSICIAN PERFORMED A WASH OUT AND POLY SWAP. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY FOR INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13485695 ↗