Equinoxe 314-02-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862175069), received between Sep 1, 2023 and Feb 20, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Mar 6, 2024Open, Classified

   The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

   Z-1407-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Mar 6, 2024Open, Classified

   The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

   Z-1406-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

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

  APPROXIMATELY 12 YEAR(S) AND 7 DAY(S) POST-OPERATIVE OF A LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING WITH GRADUAL INCREASED PAIN, DECREASED FUNCTION, AND LOOSENING ON X-RAY. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION WITH THE REPORTED REMOVAL OF THE REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, AND GLENOID COMPONENTS. ADDITIONALLY, THE PATIENT WAS REVISED TO A HEMIARTHROPLASTY AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. 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; Aseptic loosening; Pain

  MAUDE report 21428194 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  WHILE INVESTIGATING A 2023 REVISION FOR THIS PATIENT, IT WAS FOUND THAT A 63 YO MALE PATIENT HAD A PRIOR REVISION ON (B)(6) 2018. NO FURTHER INFORMATION KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18268505 ↗
• InjurySep 1, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE EQUINOXE SHOULDER STUDY THAT THIS 56 Y/O MALE PATIENT HAD A SHOULDER DISLOCATION. POST OP X-RAY REVEALED SHOULDER WAS DISLOCATED. ACTION TAKEN: REDUCED IN THEATRE NEXT DAY. PATIENT WAS DISCHARGED IN A SLING ON (B)(6) 2019. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 17669421 ↗