INFINITY™ EVERLAST™ 33685506Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889797074674), received between Dec 9, 2021 and Sep 5, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2023 WITH STRESS REACTION, MEDIAL ANKLE. PAIN & SWELLING OVER MEDIAL SUPRAMALLEOLAR REGION. THE PATIENT DENIES INJURY OR TRAUMA. THE SYMPTOMS WERE WORSE WITH WEIGHT BEARING. THE PATIENT WAS TREATED WITH MEDICATION, BOOT AND ICE. ON (B)(6) 2023, THE PATIENT REPORTED THAT THE PAIN IMPROVED BUT NOT COMPLETELY RESOLVED.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 17687265 ↗
• InjuryJul 28, 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 EXPLANATION SURGERY DUE TO INFECTION. THE PATIENT RECEIVED A CEMENT SPACER IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17413493 ↗
• InjuryDec 9, 2021Adverse 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 WITH TENDON EXPOSURE. NO DEEP INFECTION APPRECIATED, BUT IN PATIENTS BEST INTEREST TO PERFORM SURGICAL IRRIGATION AND DEBRIDEMENT. PATIENT UNDERWENT SURGICAL I&D COMPLETED WITH ANTIBIOTIC POWDER TO WOUND AND WOUND VAC PLACEMENT. MOST RECENT POST OP NOTE ON NOTES INCISION HEALING WELL. PATIENT SEEING WOUND CARE WEEKLY TO CHANGE DRESSINGS AND MONITOR PROGRESS. PHYSICIANS NOTE FROM (B)(6) 2021 STATES THAT WOUND DEHISCENCE STILL PRESENT. REFERRAL TO PLASTIC SURGERY AND PLAN FOR DEBRIDEMENT AND COVERAGE ON (B)(6) 2021. PATIENT STATES THAT OVERALL ANKLE FEELS MUCH BETTER COMPARED TO PRE-OPERATIVELY. SKIN GRAFT DID NOT TAKE AT THE ANTERIOR ASPECT OF THE WOUND. NO EXPOSED TENDON. NOTICEABLE DISCOLORATION VASCULOPATHY CHANGES OF THE LOWER LEG. PATIENT STATE THAT THEY ARE CONSIDERING A MUSCLE FLAP FOR COVERAGE. POSSIBLE REFERRAL TO VASCULAR SPECIALIST TO CONFIRM ADEQUATE BLOOD SUPPLY GIVEN THE ONGOING WOUND HEALING SINCE FEBRUARY. PATIENT STATES THAT HIS ANKLE FEELS BETTER THAN IT DID PRE-OPERATIVELY. VERY PLEASED WITH HIS ANKLE.

  Patient problems: Wound Dehiscence

  MAUDE report 12969557 ↗