Equinoxe 320-35-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862534910), received between May 25, 2022 and Jan 12, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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.

• InjuryJan 12, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 71 YO FEMALE PATIENT, WHO HAD A LEFT RTSA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN. THE BASEPLATE WAS OBSERVED TO BE DISLODGED FROM THE GLENOID ON CT. ONE OF THE SCREWS WAS OBSERVED TO BE BROKEN. THE HUMERAL LINER & TRAY WERE REMOVED. THE STEM WAS STILL WELL-FIXED DESPITE PROXIMAL HUMERAL BONE LOSS. THE GLENOSPHERE WAS REMOVED. THE BASEPLATE WITH ALL FOUR SCREWS WAS PULLED OUT AS ONE PIECE. ONE OF THE SCREWS WAS BROKEN. THE SURGEON FILLED THE BONE VOID WITH CAP & USED COMPETITOR¿S COMPONENTS FOR THE GLENOID BASEPLATE & GLENOSPHERE. THE SURGEON THEN IMPLANTED A NEW HUMERAL TRAY & LINER. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY IMAGE WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 24049022 ↗
• InjurySep 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. APPROXIMATELY 25 MONTHS POST-OP, THE PATIENT EXPERIENCED EARLY PAIN FROM POST-OP ALLODYNIA/PLEXOPATHY. SUBSEQUENTLY THE GLENOID AND HUMERUS BECAME SEPTICALLY LOOSE. AS A RESULT, APPROXIMATELY 30 MONTHS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT REVISION PROCEDURE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain; Septic loosening

  MAUDE report 23027582 ↗
• InjuryFeb 23, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 1 YEAR AND 5 MONTHS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT'S BASEPLATE LOOSENED AND THE PATIENT WAS REVISED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21442756 ↗
• InjuryFeb 12, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 9 MONTHS POST INITIAL OPERATION. IT WAS STATED THAT THE IMPLANT HAD FAILED AND THE INFERIOR SCREW HAD BROKEN. UPON REVISION, FOUND OUT THAT THE IMPLANT WAS PUT IN UPSIDE DOWN. SURGEON REMOVED AS MUCH OF THE BROKEN SCREW AS HE COULD, BUT PART OF THE SCREW WAS STILL LEFT FRAGMENTED IN THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 21364476 ↗
• MalfunctionMar 19, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY, THAT INTRA-OP, THE 76 YO FEMALE PATIENT SUSTAINED A SCAPULAR FRACTURE OF THE TIP OF THE CORACOID THROUGH ANTERIOR SCREW, LIKELY FROM PULL OF ANTERIOR GLENOID RETRACTOR. THERE WAS NO ACTION TAKEN. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16570566 ↗
• InjuryMay 25, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP THE TSA, THIS (B)(6) FEMALE PATIENT WAS REVISED TO A STANDARD REVERSE DUE TO ASEPTIC GLENOID LOOSENING. BASEPLATE LOOSENED WHICH WAS FOLLOWED BY STEM LOOSENING. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant

  MAUDE report 14498404 ↗