Equinoxe 320-15-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862242556), received between Apr 3, 2019 and Feb 20, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 6 YEAR(S), 1 MONTH(S) AND 10 DAY(S) POST-OPERATIVE OF A REVISED LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. LOOSE BASEPLATE IN RTSA REVISED FROM TSA FOR FAILED GLENOID (SEE CASE (B)(4)) LUCENCY ON X-RAY SINCE 2019. GRADUAL INCREASED PAIN AND LOSS OF FUNCTION; WITH SUDDEN INCREASE IN PAIN WHILE PLAYING PICKLEBALL. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION WITH THE REPORTED REMOVAL OF TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW, GLENOID BASE PLATE, AND COMPRESSION SCREW/LOCKING CAP COMPONENTS. ADDITIONALLY, THE PATIENT WAS REVISED TO A HEMIARTHROPLASTY AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain

  MAUDE report 21428507 ↗
• InjurySep 11, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY TWO MONTHS POST INITIAL TSA, THE 57 Y/O MALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. THE BASEPLATE BECAME LOOSE EARLY AFTER SURGERY BUT BECAME COMPLETELY DISPLACED AFTER FALL IN 7/2018. EVENT IS STILL ONGOING, THE SURGEON DISCUSSED REVISION BUT SUBJECT IS OPTING OUT FOR NOW. PER CLINICAL REPORT, THE REPORTED EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Failure of Implant; Medical device site infection

  MAUDE report 17722207 ↗
• InjuryAug 29, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 4 YEARS POST OP INITIAL RTSA, THIS 73 Y/O FEMALE PATIENT WAS REVISED DUE TO ASEPTIC GLENOID LOOSENING. RTSA GLENOID LOOSENING FIRST NOTED (B)(6) 2021. WORSENING PAIN AND EVENTUAL DISLOCATION ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant; Joint Dislocation; Pain

  MAUDE report 17644787 ↗
• InjuryAug 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 66 YO FEMALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING AND GRADUAL BASEPLATE LOOSENING WITH BROKEN SCREW. NO SPECIFIC MECHANISM WAS NOTED. THE DATE OF ONSET IS (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2022. THE OUTCOME WAS LAST KNOWN AS RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 17452205 ↗
• InjurySep 6, 2019Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE REVISION WAS DUE TO THE GLENOSPHERE BECOMING DISASSOCIATED FROM THE BASE PLATE TWO MONTHS AFTER THE INITIAL IMPLANT SURGERY. THE SURGEON USED THE SUPERIOR POSTERIOR GLENOID PLATE, A 38 GLENOSPHERE AND THE GLENOSPHERE LOCKING SCREW. HE ENCOUNTERED NO PROBLEM DURING THE FIRST SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 8969016 ↗
• InjuryApr 3, 2019Loose or Intermittent Connection

  REVISION DUE TO INFECTION. IT WAS INFECTED AND LOOSE.

  Patient problems: Unspecified Infection

  MAUDE report 8477579 ↗