Equinoxe 320-35-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862534903), received between Nov 2, 2021 and Apr 24, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2024Break; Material Deformation; Positioning Problem; Break; Material Deformation; Positioning Problem

  AS REPORTED, THE IMPLANT WAS OPENED AND LOADED WITH BONE GRAFT BY THE SURGICAL TECH BEFORE IMPACTION. DURING IMPACTION THE IMPLANT WOULD NOT FULLY SEAT AND WAS PULLED OUT TO REASSESS. UPON LOADING THE IMPLANT BACK ON THE INSERTER IT WAS NOTICED BY THE TECH THAT THE CAGE HAD WARPED. THE SURGEON THEN DECIDED TO WASTE THE IMPLANT AND PUT IN A NEW ONE. THE NEW BASEPLATE WAS IMPACTED WITH NO ISSUES. THIS EVENT IS NOT ASSOCIATED WITH A REVISION OF EXACTECH IMPLANTS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177879 ↗
• InjuryMay 23, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP INITIAL TSA, THIS 77 Y/O FEMALE PATIENT WAS REVISED DUE TO ASEPTIC GLENOID LOOSENING WITH INCREASED PAIN. SURGEON REVISED TO A HEMIARTHROPLASTY. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND UNLIKELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Aseptic loosening; Failure of Implant; Pain

  MAUDE report 16987479 ↗
• InjuryNov 2, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 1 YR. POSTOP THE IMPLANTED LTSA AND ENTERED THIS CLINICAL STUDY, THIS (B)(6) FEMALE PATIENT WHO HAD A HISTORY OF INFECTIONS IN PRIOR IMPLANTED DEVICES (MANUFACTURERS UNKNOWN) PRESENTED WITH ASEPTIC GLENOID LOOSENING. RADIOGRAPHS SHOWED ASEPTIC GLENOID LOOSENING AND THAT THE BONE GRAFT HAD NOT INCORPORATED. THE SURGEON OPTED TO DO A STAGED REVISION WITH BONE GRAFTING OF THE ILIAC CREST TO THE GLENOID FOLLOWED BY A REVISION TO A REVERSE TSA. THE FIRST PROCEDURE (REMOVAL OF COMPONENTS, BONE GRAFTING, AND PLACING ANTIBIOTIC SPACERS) WAS PERFORMED ON (B)(6) 2021. THE CONVERSION TO A REVERSE TSA WAS PERFORMED ON (B)(6) 2021. THE PATIENT WAS AN INPATIENT FOR 2 DAYS AND DISCHARGED HOME. THIS EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2021. THE CASE REPORT FORM INDICATES THIS EVENT IS NOT RELATED TO DEVICES AND DEFINITELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant

  MAUDE report 12736810 ↗