Equinoxe 320-02-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862186751), received between Dec 23, 2019 and Nov 6, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY ONE MONTHS POST OPERATION. HRP WAS DISLOCATING DUE TO LACK OF SOFT TISSUE TENSION. PATIENT REVISED TO EXACTECH DEVICES: LINER AND GLENOSPHERE WERE UPSIZED TO 42MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: DISCARDED AT THE HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 20616861 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN 89 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6)2022 , UNDERWENT A REVISION PROCEDURE ON (B)(6)2022 , APPROXIMATELY 5 MONTHS POST THE INITIAL PROCEDURE DUE TO DISLOCATION, SCAPULAR NOTCHING INDICATED AS THE REASON. THE PATIENT WAS REVISED TO EXACTECH DEVICES. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION REPORTED. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE. THE DEVICES WILL NOT TO BE RETURNED DUE TO BEING DISCARDED BY THE HOSPITAL. NO ADDITIONAL INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16140987 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A (B)(6) MALE ORIGINAL SHOULDER IMPLANT DISLOCATED. THE SURGEON TRIED TO DO A CLOSED REDUCTION ON THE PATIENT AND WAS UNSUCCESSFUL, THEREFORE THE PATIENT RECEIVED A REVISION OF THE RIGHT HRP WITH A SMALLER SIZE SO THE JOINT COULD BE REDUCED. REVISED THE GLENOSPHERE FROM A 38 +4 TO JUST A 38 AND REVISED THE PROXIMAL BODY FROM A LARGE TO AN EXTRA SMALL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE AVAILABLE FOR RETURN., . REVISED THE GLENOSPHERE FROM A 38 +4 TO JUST A 38 AND REVISED THE PROXIMAL BODY FROM A LARGE TO AN EXTRA SMALL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE AVAILABLE FOR RETURN.

  Patient problems: Joint Dislocation

  MAUDE report 10152533 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MALE PATIENT¿S ORIGINAL LEFT TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2019. THE PATIENT WAS DISLOCATING AND WAS REVISED ON (B)(6) 2019. A SECOND REVISION WAS COMPLETED ON (B)(6) 2019 DUE TO DISLOCATING. THE SURGEON STATED ¿HE BELIEVES THAT ON THE ORIGINAL CASE, HE MAY NOT HAVE MADE IT (THE SHOULDER) TIGHT ENOUGH. DURING THE REVISION, THE HUMERAL LINER WAS REMOVED ALONG WITH THE GLENOSPHERE AND LOCKING SCREW. AFTER TRIALING COMPONENTS, A NEW EXPANDED GLENOSPHERE TO LATERALIZE THE CENTER OF ROTATION WAS IMPLANTED. THEN TRIALED WITH A CONSTRAINED LINER AND DECIDED THAT THIS GAVE THE PATIENT A VERY STABLE SHOULDER. ALL FINAL IMPLANTS WERE IMPLANTED, THE SHOULDER WAS REDUCED AND CLOSED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WERE DISPOSED OF BY THE HOSPITAL. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 9512872 ↗