Equinoxe 320-15-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862186683), received between Jul 14, 2021 and Jul 29, 2026 — classified as 7 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Unstable

  It was reported that this patient underwent a left shoulder replacement. Subsequently, they were revision due to instability involving the glenoid aspect. Intraoperatively, the glenoid baseplate and glenosphere construct were noted to be posteriorly rotated. During removal of the glenosphere, the glenoid components were removed concurrently with the glenosphere. All implanted components were subsequently explanted and revised to a competitor's hemiarthroplasty. Polyethylene wear of the humeral liner was also observed. The patient was last known to be in stable condition following the event.

  Patient problems: Joint Laxity

  MAUDE report 50068263 ↗
• InjuryJul 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YEARS AND 5 MONTHS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT COMPLAINED ABOUT MILD PAIN IN THE SHOULDER AND PRESENTED WITH LOOSENING ON THE GLENOID SIDE. WHETHER THIS IS CAUSED BY FALL OR INFECTION IS UNCONFIRMED. THE SURGEON REMOVED THE IMPLANTS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT AS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Fall; Pain; Unspecified Infection

  MAUDE report 22558829 ↗
• InjuryDec 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5 YEARS AND 8 MONTHS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO COMPONENT LOOSENING. THERE WAS SEVERE BONE LOSS. 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; Osteolysis

  MAUDE report 20948152 ↗
• InjuryAug 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 79 YO MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED IN (B)(6) 2018, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 7 YEARS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON WITH COMPLAINTS ABOUT SOME MILE PAIN IN THEIR SHOULDER. DURING THE PROCEDURE, WHEN OPENED, THEY PRESENTED WITH LOOSENING ON THE GLENOID SIDE AND A SNAPPED SCREW. IT WAS INDICATED A FALL WAS SUSPECTED. ALL DEVICES WERE REMOVED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. NO EXPLANTED DEVICES WERE AVAILABLE FOR RETURN AS THEY WERE SENT TO ¿RPH FOR STUDY¿. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Implant Pain

  MAUDE report 19962495 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP THE INITIAL LEFT TSA, THIS FEMALE PATIENT WAS REVISED DUE TO INFECTION. THIS WAS A SUSPECTED INFECTION AS BOTH THE GLENOID BASEPLATE AND HUMERAL STEM HAD BECOME LOOSE. THE PATIENTS GLENOID HAD COMPLETELY ERODED SO THE SURGEON DECIDED TO REMOVE ALL IMPLANTS AND PUT A SPACER IN SITU UNTIL THE INFECTION WAS CLEARED. SPACER WAS REMOVED ON (B)(6) 2022 AND REPLACED BY HEMI PROSTHESES. ALL IMPLANTS WERE REMOVED FROM PATIENT. THE REPORTED EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNING.

  Patient problems: Bacterial Infection

  MAUDE report 14781662 ↗
• InjuryJun 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY AN EQUINOXE SHOULDER STUDY, APPROXIMATELY 3 YEARS POST OP THE INITIAL TSA, THIS (B)(6) Y/O MALE PATIENT WAS EXPERIENCING ASEPTIC GLENOID LOOSENING. PATIENT WAS PUSHING A SHOPPING CART, FELT POP, AND HAD INCREASED PAIN. SURGEON ORDERED A CT SCAN AND THE OUTCOME IS STILL CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND DEFINITELY NOT RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant

  MAUDE report 14567470 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS WAS REPORTED, APPROXIMATELY 3.2 YRS POSTOP THE INITIAL L TSA, THIS (B)(6) Y/O MALE PATIENT WAS REVISED. EVERYTHING WAS REMOVED AND A CEMENT SPACER WAS INSERTED DUE TO INFECTION. AFFECTED. THIS PRODUCT IS NOT AVAILABLE FOR RETURN.

  Patient problems: Bacterial Infection

  MAUDE report 12165679 ↗