INFINITY™ EVERLAST™ 33681106Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889797074353), received between Dec 20, 2022 and Jan 23, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

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

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 21215851 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: STRYKER ITAR-2 SUBJECT: (B)(6)." DURING 2Y FOLLOW-UP VISIT ON (B)(6) 2024, SUBJECT REPORTED INCREASING PAIN AND SWELLING TO THE INSIDE ASPECT OF THE LEFT ANKLE. MUSCULOSKELETAL EXAM INDICATED DIFFUSE TENDERNESS TO THE MEDIAL REGION OF THE LEFT ANKLE AND SIGNIFICANT DISCOMFORT TO THE MEDIAL GUTTER. IMAGING RESULTS SHOWED A STABLE APPEARING LEFT TOTAL ANKLE REPLACEMENT WITH NO LUCENCY AROUND THE HARDWARE. POSSIBLE IMPINGEMENT OF THE MEDIAL GUTTER WAS NOTED. SUBJECT WILL CONTINUE TO FOLLOW-UP WITH SURGEON AND IF PAIN CONTINUES THE PATIENT COULD REQUIRE MEDIAL GUTTER DEBRIDEMENT OR POSSIBLY A SPECT CT SCAN. SUBJECT WAS PRESCRIBED MELOXICAM FOR PAIN.

  Patient problems: Discomfort; Implant Pain; Joint Impingement; Swelling/ Edema

  MAUDE report 21035636 ↗
• InjuryAug 26, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A DEVICE EXPLANT SURGERY DUE TO PATIENT HAVING PAIN AND POSSIBLE LOOSENING. THE PLAN IS TO EITHER FUSE OR REVISE WITH INVISION INBONE SYSTEM.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 20071910 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT AS JUST UNDER 2 WEEKS OUT FROM TOTAL ANKLE REPLACEMENT WITH MEDIAL MALL SCREW. THE PATIENT CAME IN FOR ROUTINE POSTOP VISIT ON (B)(6) 2022. IT WAS NOTED UPON WOUND INSPECTION THAT THERE WAS SOME DRAINAGE FROM THE MEDIAL WOUND. UPON PALPATION THERE WAS A FRANK PURULENCE. BECAUSE OF THIS, INDICATED FOR I&D. AN MRI SHOWED SOME POSSIBLE CONNECTION OF THE FLUID MEDIALLY ALONG WITH OUT OF THE ANTERIOR TIBIA ALONG THE SIDE OF THE IMPLANT. THE PATIENT HAS BEEN ON IV ANTIBIOTIC THERAPY WITH ROCEPHIN AND DAPTOMYCIN. THE PATIENT IS KEEPING THE FOOL ELEVATED, HAS BEEN NON-WEIGHT BEARING IN A SPLINT AND TAKING A BABY ASPIRIN TWICE DAILY FOR DVT PROPHYLAXIS. THE PAIN IS WELL CONTROLLED AND THE INFECTION IS IMPROVING.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 16019210 ↗