Equinoxe 315-03-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862084774), received between Feb 24, 2021 and Aug 30, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2021Break; Break

  AS REPORTED, THE SURGEON WAS DISLOCATING SHOULDER AFTER TRIALING IMPLANTS AND SKID SNAPPED. GLENOID SKID SNAPPED IN 2 DIFFERENT AREAS. THE SMALLEST PIECE WAS RETRIEVED FROM THE WOUND BY THE SURGEON. IT WAS MEASURED AGAINST ANOTHER SKID TO ENSURE WE OBTAINED THE ENTIRE SKID. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389308 ↗
• MalfunctionAug 17, 2021Break; Break

  AS REPORTED, THE SURGEON WAS TRIALING IMPLANT SIZES, USED SKID TO DISLOCATE SHOULDER AND IT SNAPPED. THE MALE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PARTS OR PIECES FELL INTO THE PATIENT. THE DEVICE IS TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331139 ↗
• MalfunctionApr 9, 2021Break; Break

  AS REPORTED, THE SURGEON WAS TRYING TO GET THE RETRACTOR OUT FROM BEHIND THE GLENOSPHERE AND WHEN HE PULLED OUT THE SKID IT BROKE. NO PARTS OR PIECES, NO EFFECT ON PATIENT. DEVICE TO RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640343 ↗
• MalfunctionFeb 24, 2021Break; Break

  AS REPORTED, DURING A INITIAL SHOULDER PROCEDURE ON A (B)(6) FEMALE, THE SURGEON REDUCED SHOULDER TO TRIAL SELECTED IMPLANTS, UTILIZED SKID TO DISLOCATE TRIALS, AND SKID SNAPPED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL RETURN FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11373843 ↗
• InjuryFeb 24, 2021Break; Break

  AS REPORTED, DURING AN INITIAL TSA PROCEDURE, THE SURGEON WAS RELOCATING THE PATIENT'S SHOULDER AT THE END OF THE PROCEDURE WHEN THE SKID SNAPPED, CAUSING A SHORT DELAY. THERE WERE NO EFFECTS TO THE PATIENT CAUSED BY THE DELAY. SURGEON HAD TO REMOVE PART FROM THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11371602 ↗