Equinoxe 314-13-03 (UDI 10885862657923)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862657923), received between Nov 25, 2025 and Sep 18, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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.

• InjurySep 18, 2026Insufficient Device Problem Information

  As reported, approximately 9 years and 3 months post the initial left total shoulder arthroplasty, the patient complained of pain and was revised due to a failed glenoid component. During the revision surgery, the stem came up when trying to get the head off. 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: Pain

  MAUDE report 50827617 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED BONE DAMAGE. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 24680238 ↗
• InjuryFeb 24, 2026Structural Problem; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT A SUCCESSFUL SHOULDER ARTHROPLASTY APPROXIMATELY 10 YEARS AGO. RECENTLY, THE CAGED GLENOID COMPONENT DEMONSTRATED SIGNS OF LOOSENING. AS A RESULT, A FIRST-STAGE REVISION PROCEDURE WAS PERFORMED, ALL IMPLANTS WERE REMOVED WITHOUT COMPLICATION. PHOTOGRAPHS OF THE EXPLANTS WERE PROVIDED, AND WEAR WAS OBSERVED ON THE GLENOID COMPONENT. THE PATIENT WAS LAST REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Septic loosening

  MAUDE report 24434267 ↗
• InjuryFeb 16, 2026Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A 61 YO MALE PATIENT, WHO HAD AN INITIAL TSA NOTED INCREASED PAIN AND REDUCE ROM SINCE (B)(6) 2025. GLENOID LOOSENING NOTED ON A FOLLOW UP CT SCAN. ACTION TAKEN WAS MEDICATION. THE EVENT WAS POSSIBLY RELATED TO THE DEVICES BUT UNLIKELY RELATED TO THE PROCEDURE. OUTCOME INDICATES CONTINUING. NO DEVICES AVAILABLE FOR RETURN DUE TO CLINICAL STUDY. NO FURTHER INFORMATION.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Pain

  MAUDE report 24353348 ↗
• InjuryFeb 9, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YEARS AND 1 MONTH POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PAIN FROM A LOOSE GLENOID. 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: Aseptic loosening; Pain

  MAUDE report 24292310 ↗
• InjuryNov 25, 2025Fracture; Naturally Worn; Lack of Effect; Fracture; Naturally Worn; Lack of Effect

  IT WAS REPORTED THAT A 71 YO MALE PATIENT WHO HAD A RIGHT TSA, UNDERWENT A REVISION PROCEDURE. THE SHOULDER WAS REVISED DUE TO INCREASED PAIN AND REDUCED ROM OVER THE LAST 12 MONTHS. ON X-RAY THERE WAS EVIDENCE OF LYSIS OF BOTH HUMERAL AND GLENOID COMPONENTS. ALL IMPLANTS WERE REMOVED AS INFECTION COULD NOT BE RULED OUT. TESTING CONFIRMED THAT ALL SAMPLES WERE NEGATIVE EXCEPT ONE - STAPH EPI ON ENRICHED GROWTH. SIGNIFICANT GLENOID WEAR WAS NOTED, LIKELY REQUIRING A CUSTOM GLENOID. THE CUFF WAS STILL IN TACT ON THE DAY OF THE REVISION. A CEMENT SPACER IS NOW INSITU. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. . NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Bacterial Infection; Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 23641080 ↗