INFINITY™ EVERLAST™ 33684307Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889797074551), received between Apr 7, 2022 and Oct 28, 2025 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(4). STUDY: STRYKER ITAR-2 - INFINITY WITH ADAPTIS. GUTTER IMPINGEMENT: NARRATIVE OF ADVERSE EVENT: PATIENT PRESENTED WITH CONTINUED PAIN IN HIS MEDIAL ANKLE. EXAM OF ANKLE FOUND SLIGHT ANKLE VARUS, TENDERNESS PALPATION OVER THE MEDIAL GUTTER, ESPECIALLY DISTALLY. ISOLATED RIGHT ANKLE MEDIAL GUTTER DEBRIEDMENT PERFORMED.

  Patient problems: Joint Impingement; Pain

  MAUDE report 23402241 ↗
• InjurySep 10, 2025Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO IMPLANT FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 23018818 ↗
• 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. TALAR COMPONENT IMPINGEMENT AND CONTINUED PAIN SUBJECT CONTINUES TO HAVE SUSTAINED ANTERIOR MEDIA ANKLE AND DISTAL TIBIAL PAIN. PAIN IS LIKELY DUE TO IMPINGEMENT BETWEEN HIS MEDIAL MALLEOLUS AND TALAR COMPONENT, LIKELY RELATED TO HIS MILD VARUS ALIGNMENT.

  Patient problems: Implant Pain; Joint Impingement

  MAUDE report 22963646 ↗
• InjuryJul 2, 2025Adverse 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 UNDERWENT A DEVICE EXPLANT SURGERY BECAUSE THE PATIENT HAD SOME PAIN AND WAS TAKEN FOR POLY SWAP/GUTTER DEBRIDEMENT AND CULTURING. THE CULTURES SHOWED INFECTION SO THE IMPLANTS WERE REMOVED. THE PATIENT RECEIVED A CEMENT ANTIBIOTIC SPACER. THE PLAN IS TO CONVERT TO INVISION SYSTEM FOLLOWING ANTIBIOTIC TREATMENT AND CLEARANCE OF ANY ACTIVE INFECTION.

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 22386706 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). ADVERSE EVENT" DELAYED WOUND HEALING PATIENT ARRIVES TO CLINIC WITH A WOUND TO THE ANTERIOR ANKLE. HAS BEEN TAKING ANTIBIOTICS. HAS SHOOTING PAINS UP THE ANTEROMEDIAL ANKLE. THERASKIN SKIN GRAFT WAS APPLIED IN OFFICE TO PROMOTE HEALING OF WOUND."

  Patient problems: Implant Pain; Wound Dehiscence

  MAUDE report 20543749 ↗
• 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 DRAINAGE. DELAYED WOUND HEALING. NOTED A VERY SMALL AREA OF DRAINAGE ON THE INCISION ANTERIOR TO ANKLE (B)(6) 2022. TOPICAL ANTIBIOTIC WAS PRESCRIBED. ON (B)(6) 2022 SMALL ESCHAR 1CM FROM WOUND WAS NOTED. DRAINAGE WAS NOTED IN (B)(6) 2022 PATIENT RECEIVED 3 WEEK COURSE OF KEFLEX AND THE GRANULOMA WAS INSPECTED. (B)(6) 2022 NO FURTHER ISSUES. DRAINAGE RESOLVED."

  Patient problems: Wound Dehiscence

  MAUDE report 20426078 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: SUBJECT: (B)(6) INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) PERSISTENT PAIN. PATIENT WHO WAS 15 MONTHS OUT FROM TAA EXPRESSED DISSATISFACTION WITH POSTOPERATIVE PAIN RELIEF. POSTOPERATIVE X-RAYS AND CT DID NOT REVEAL ANY INFECTION, HARDWARE LOOSENING, POLYETHYLENE SPACER WEAR, NOR PERIPROTHESIS LUCENCY, BUT DEMONSTRATED SOME EVIDENCE OF BONY OVERGROWTH OR IMPINGEMENT TO THE MEDIAL GUTTER. PATIENT WAS THEN RECOMMENDED OPTION OF SURGERY WHICH HE ELECTED TO PROCEED WITH. REVISION SURGERY ON (B)(6) 2023 WITH REPLACEMENT OF THE POLYETHYLENE INSERT."

  Patient problems: Implant Pain; Joint Impingement

  MAUDE report 20298702 ↗
• InjuryJun 25, 2024Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "ADVERSE EVENT : IMPLANT FAILURE. NARRATIVE OF ADVERSE EVENT : IMPLANT FAILED. LOOSENING AND SUBSIDENCE WAS NOTICED ON IMAGING POST-OP ON (B)(6) 2024. IT NEEDS TO BE REMOVED AND REPLACED." REVISION SURGERY WAS PERFORMED ON (B)(6) 2024."

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 19610599 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT, WHO UNDERWENT AN INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT, REPORTED STIFFNESS AND MEDIAL PAIN IN THE ANKLE DURING A CLINIC VISIT. RELIEF WAS FOUND FROM A PREVIOUS GUTTER DEBRIDEMENT PROCEDURE, BUT MEDIAL PAIN PERSISTED, EXACERBATED BY ACTIVITY. SWELLING WAS RELIEVED WITH REST AND ELEVATION. SPECT CT SCAN SHOWED INCREASED UPTAKE ALONG THE MEDIAL ANKLE AND TALUS, BUT NO IMPLANT LOOSENING WAS FOUND. TREATMENT INCLUDED CONTINUATION OF A HOME EXERCISE PROGRAM AND PRESCRIBED VOLTAREN GEL, WITH CONSIDERATION OF FUTURE MEDIAL GUTTER DEBRIDEMENT AND PLACEMENT OF A MEDIAL OSSIO SCREW. AN UPDATE INDICATED THAT THE PATIENT UNDERWENT A PLANNED OUTPATIENT PROCEDURE, INCLUDING ANKLE OPEN REDUCTION INTERNAL FIXATION MEDIAL MALLEOLUS WITH EXCISION OF MEDIAL LATERAL SPURS, GUTTER DEBRIDEMENT, AND RIGHT ANKLE SYNOVECTOMY, ADDRESSING THE PREVIOUSLY REPORTED ADVERSE EVENTS. FURTHER DETAILS WERE PENDING COMPLETION AND SIGNING OF THE OPERATIVE NOTE. IT WAS NOTED THAT THE PATIENT HAD UNDERGONE THE OUTPATIENT PROCEDURE TO ADDRESS THE ADVERSE EVENTS MENTIONED EARLIER.

  Patient problems: Implant Pain; Loss of Range of Motion; Synovitis

  MAUDE report 19110030 ↗
• InjuryDec 21, 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 UNDERWENT A DEVICE EXPLANT PROCEDURE DUE TO INFECTION. THE PATIENT WAS IMPLANTED WITH A CEMENT SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 18379234 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED 6 WEEKS POST LEFT TOTAL ANKLE REPLACEMENT PROCEDURE. IT WAS NOTED THAT THERE WAS ANTERIOR SURGICAL WOUND DEHISCENCE AND SEROUS FLUID DRAINAGE. THE PHYSICIAN COMPLETED AND IRRIGATION AND DEBRIDEMENT ON (B)(6) 2023. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Fluid Discharge; Wound Dehiscence

  MAUDE report 18034803 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED 6 WEEKS POST PROCEDURE WITH MRSA INFECTION. THE PATIENT HAD ABOUT ONE MONTH WITH WOUND DEHISCENCE THAT CHRONICALLY DIDN'T HEAL THAT EVENTUALLY HAD PSEUDOMONAS THAT GOT LONG TERM ANTIBIOTICS. THE PHYSICIAN EXPLANTED ALL IMPLANTS AND IMPLANTED A CEMENT SPACER. WHEN THE PHYSICIAN INITIALLY SAW THE PATIENT THEY PRESENTED WITH HUGE ANTERIOR WOUND AND A POSTEROMEDIAL DRAINING SINUS. ON THE ENSUING DAYS AFTER EXPLANT PATIENT SEEDED LEFT ARTIFICIAL KNEE AND LEFT NATIVE ANKLE. THE PHYSICIAN SAYS THAT HE WENT BACK TO OPERATING ROOM A COUPLE MORE TIMES (DIDN'T STATE PROCEDURES). THE PHYSICIAN STATES THE PHYSICIAN IS HEALING APPROPRIATELY NOW AND DOING FINE. THE SURGEON STATES ROUGHLY TWO TO THREE MONTHS AND THEY WILL REVISE WITH INVISION TOTAL ANKLE.

  Patient problems: Bacterial Infection; Fluid Discharge; Wound Dehiscence

  MAUDE report 17599444 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THEIR 6 MONTH FOLLOW UP ON (B)(6) 2023, THE PATIENT COMPLAINED OF ANKLE SWELLING, PAIN, AND STIFFNESS. THE PI RECOMMENDED THE PATIENT UNDERGO RIGHT ANKLE DEBRIDEMENT. PATIENT AGREED AND THE PROCEDURE WAS SCHEDULED FOR (B)(6) 2023. DURING THE PROCEDURE THE MEDIAL LATERAL GUTTERS WERE CLEARED OUT OF ANY SPURS AND BONE. PATIENT WAS DISCHARGED ON THE SAME DAY.

  Patient problems: Implant Pain; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 17062425 ↗
• InjuryApr 7, 2022Adverse 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 REMOVAL DUE TO INFECTION TWO WEEKS POST IMPLANT PROCEDURE. THE PATIENT HAS A REVISION PROCEDURE SCHEDULED FOR A LATER DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 14039859 ↗