Equinoxe 314-13-14 (UDI 10885862657954)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862657954), received between Apr 21, 2026 and Jun 12, 2026 — classified as 3 injuries.

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 18, 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.

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

  IT WAS REPORTED VIA CLINICAL STUDY THAT PATIENT UNDERWENT A LEFT SHOULDER REPLACEMENT. SUBSEQUENTLY, THE PATIENT DEVELOPED ASEPTIC GLENOID LOOSENING, PRESENTING WITH SHOULDER PAIN. X-RAYS DEMONSTRATE STABLE ALIGNMENT WITH SLIGHT LUCENCY AT THE INFERIOR GLENOID PEGS. THE DEVICE REMAINS IMPLANTED AT THIS TIME AS A REVISION IS PLANNED FOR ON (B)(6) 2026. THE OUTCOME IS CONSIDERED CONTINUING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain; Radiolucent Lines

  MAUDE report 25485589 ↗
• InjuryMay 4, 2026Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SHOULDER REPLACEMENT AND WAS SUBSEQUENTLY REVISED. DURING THE REVISION PROCEDURE, THE GLENOID EXHIBITED METALLOSIS. THE GLENOID CAGE WAS NOTED TO BE LOOSE AND DID NOT REQUIRE THE USE OF PEG EXTRACTORS FOR REMOVAL. THERE WAS NOTED WEAR. ALL IMPLANTED COMPONENTS WERE EXPLANTED. THE SURGEON IMPLANTED A COMPETITOR¿S HUMERAL COMPONENTS ALONG WITH A CUSTOM GLENOID COMPONENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology

  MAUDE report 25072085 ↗
• InjuryApr 21, 2026Detachment of Device or Device Component

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 10 YEARS AND 2 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO DISASSOCIATION OF THE POLYETHYLENE. THE PATIENT HAD BEEN EXPERIENCING PAIN AND WEAKNESS SINCE 2024 WITHOUT A SPECIFIC MECHANISM OF INJURY/TRAUMA. TOTAL SHOULDER ARTHROPLASTY GLENOID POLY SHEAR FAILURE WAS FOUND ON X-RAY. THE REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD AND GLENOID WERE REMOVED AND THE PATIENT WAS REVISED TO AN EXACTECH HYBRID IMPLANT. THE OUTCOME IS CONSIDERED TO BE RESOLVED.

  Patient problems: Muscle Weakness/Atrophy; Pain

  MAUDE report 24945325 ↗