INFINITY™ EVERLAST™ 33685407Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889797074636), received between Jan 30, 2023 and May 8, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN 2024 -2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION ACTIVE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 25122284 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  THE REASON FOR REVISION PERIPROSTHETIC TAR INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24071081 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN JUNE 2025 TO SEPTEMBER 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO LYSIS IN TALUS AND INFECTION - ACTIVE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23687344 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY WITH ADAPTIS (ITAR2) STUDY. (B)(6) 2023: NARRATIVE OF ADVERSE EVENT: THE PATIENT IS A 64 Y.O. YEAR OLD MALE WHO IS HERE FOR FOLLOW UP OF LEFT TAR. HE REPORTS CONTINUED PARESTHESIAS AT THE DORSAL FOREFOOT AND PAIN AT THE MEDIAL ANKLE. HIS PAIN IS OVERALL BETTER COMPARED TO PRE-SURGERY. ON PE, ANKLE MOTION IS 10 DEGREES DORSIFLEXION, 40 DEGREES PLANTARFLEXION. X-RAYS SHOW THE TOTAL ANKLE PROSTHESIS APPEARS STABLE, NO EVIDENCE OF LOOSENING, FRACTURES, AND IN ACCEPTABLE ALIGNMENT. THERE APPEARS TO BE BONY IMPINGEMENT AT THE TIP OF THE MEDIAL MALLEOLUS W/ THE TALUS. I SUSPECT THAT HIS PAIN IS DUE TO MEDIAL ANKLE IMPINGEMENT. OUR NEXT STEP WOULD BE TO EITHER HAVE HIM UNDERGO A DIAGNOSTIC INJECTION OF NUMBING MEDICINE INTO THE MEDIAL ANKLE VERSUS SENDING HIM FOR A SPECT SCAN. HE ELECTS TO PROCEED W/ THE DIAGNOSTIC INJECTION. HE WAS ADVISED TO BE VERY ACTIVE DURING THE NEXT 24 HOURS AND WORK ON ANKLE PUMPS TO DETERMINE THE LEVEL OF RELIEF FROM THE INJECTION. FUTURE OPERATIVE TREATMENT WOULD CONSIST OF A MEDIAL ANKLE GUTTER DEBRIDEMENT IF THE INJECTION WERE TO PROVIDE RELIEF. INJECTION: LEFT ANKLE JOINT. AFTER INFORMED CONSENT WAS OBTAINED, THE INJECTION SITE WAS P

  Patient problems: Joint Impingement; Numbness; Pain

  MAUDE report 23355588 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: STRYKER ITAR-2. SUBJECT: (B)(6). INFECTION, DEEP PATIENT CAME IN FOR 2-YR FOLLOW UP ON MAR 13 AND HAD BEEN DOING VERY CLINICALLY WELL UNTIL THAT POINT. STARTING MAR 27TH, PATIENT STARTED EXPERIENCING SYMPTOMS OF PAIN, REDNESS, AND SWELLING IN AND AROUND THE STUDY ANKLE, FEVER AS WELL FOLLOWING SEVERAL DENTAL PROCEDURES. WORKUP SHOWED INCREASED INFLAMMATORY MARKERS AND AN MRI SUSPICION OF INFECTION AROUND THE ANTERIOR TIBIAL TENDON. PRESUMED IT WAS DEEP ALSO BECAUSE OF THE PROXIMITY OF THE IMPLANT. EXPLAINED RISK AND BENEFITS OF THE RATIONALE FOR URGENT BASED SURGERY TO DO AN I&D AND RETAIN THE PROSTHESIS BUT EXCHANGE THE POLYETHYLENE."

  Patient problems: Fever; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 21948037 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ADAPTIS SUBJECT (B)(6) PATIENT PRESENTED TO CLINIC ON (B)(6) 2022 (5 WEEKS AND 5 DAYS S/P LEFT TAR PROCEDURE), C/O PLANTAR NUMBNESS AND DIFFICULTY WITH TOE FLEXION. UPON EXAM, THE SURGEON CONFIRMED SUPERFICIAL AND PERONEAL NERVES ARE INTACT. SURAL NERVE IS INTACT. THE SURGEON ORDERED AN EMG; ON (B)(6) 2022 EMG REPORT/CLINICAL IMPRESSION: PATIENT HAS COMPRESSIVE NEUROPATHY AT LEFT TARSAL TUNNEL AND FIBULAR HEAD, DUE TO POSTOP SWELLING, CASTING, AND THE BOOT. F/U PENDING. UPDATE 07 MAR 2023: PATIENT CONTINUES TO HAVE TIBIAL NERVE IRRITATION. THE SURGEON DOES NOT BELIEVE THIS EVENT IS DUE TO A TRAUMATIC TIBIAL NERVE LACERATION DURING TAR PROCEDURE, BUT RESIDUAL IRRITATION FROM THE NERVE BLOCK OR SWELLING."

  Patient problems: Loss of Range of Motion; Neuropathy; Numbness; Swelling/ Edema

  MAUDE report 20307754 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: 100-004 INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) PATIENT HAS WOUND BREAKDOWN IN THE MIDDLE PORTION OF THE INCISION."

  Patient problems: Wound Dehiscence

  MAUDE report 20298705 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2): SUBJECT (B)(6). AS REPORTED: "LEFT ANKLE PAIN, SWELLING, AND NUMBNESS PATIENT WAS SEEN FOR 3 MONTH FOLLOW UP OF LEFT ANKLE ON (B)(6) 2023 WITH COMPLAINTS OF PAIN, SWELLING, AND NUMBNESS SINCE LAST VISIT ON (B)(6) 2023. MOST OF THE PAIN WAS REPORTED OUTSIDE ASPECT OF ANKLE. EXAMINATION SHOWED WELL-HEALED SCAR WITH TENDERNESS OF LEFT SUBTALAR JOINT WITH MINIMAL DISCOMFORT LATERAL ASPECT OF THE ANKLE. RADIOGRAPHIC IMAGING SHOWED NO EVIDENCE OF LUCENCY. AROUND THE HARDWARE. PATIENT IS TO CONTINUE WEARING BOOT, PHYSICAL THERAPY, USE VOLTAREN GEL, AND STABILIZE THE ANKLE WITH PRESCRIBED LACE-UP ANKLE BRACE."

  Patient problems: Discomfort; Implant Pain; Numbness; Swelling/ Edema

  MAUDE report 17865029 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EIGHT MONTHS POST-OPERATION WHEN THEY STARTED HAVING PAIN ON INSIDE OF THE ANKLE. IT WAS IDENTIFIED THAT THEY HAD GUTTER IMPINGEMENT MEDIALLY AND LATERALLY. THE PATIENT NEEDED TO HAVE THE POLYETHYLENE PORTION REPLACED AND DEBRIDE THE GUTTERS IN SURGERY.

  Patient problems: Implant Pain

  MAUDE report 17817799 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL IMPLANT REMOVED DUE TO INFECTION THAT WAS UNRELATED TO THE TOTAL ANKLE SURGERY. IMPLANT WAS REMOVED AND ANTIBIOTIC CEMENT SPACER WAS INSERTED. ORAL ANTIBIOTICS PRESCRIBED.

  Patient problems: Unspecified Infection

  MAUDE report 16268919 ↗