Equinoxe 300-62-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862536761), received between Sep 29, 2021 and Aug 24, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that the patient underwent a left shoulder replacement. Subsequently, the patient developed shoulder pain following an episode of locking while swimming breaststroke. The patient had been functioning well prior to this event.Radiographs confirmed loosening of the stemless humeral component. The surgeon removed the humeral components without complication. The glenoid component was found to be well fixed in situ; however, minor wear and fraying of the polyethylene was noted along the posterior edge, consistent with a posterior dislocation event. The consultant removed frayed polyethylene to reduce the risk of further fragmentation and intra-articular entrapment and left the glenoid component in situ.The humeral components were revised to stemmed anatomic components. A slightly oversized humeral head was implanted to increase joint stability. Postoperatively, imaging was satisfactory. Samples were obtained and remained pending at the time of reporting. The consultant did not suspect an infectious etiology. The patient was last known to be in stable condition following the event. No further information is available.

  Patient problems: Aseptic loosening; Joint Dislocation; Pain

  MAUDE report 50412475 ↗
• InjurySep 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 3 MOS POSTOP THE INITIAL LTSA, THIS (B)(6) Y/O MALE PATIENT HAD A FAILED GLENOID THAT HAD BEEN REMOVED ARTHROSCOPICALLY. NOW, APPROXIMATELY 3 MOS LATER, THE PATIENT HAD CONTINUED PAIN AND OPTED FOR A FULL REVISION. A STEMLESS SHOULDER WAS REMOVED, AND A REVERSE WAS PUT IN ITS PLACE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN DUE TO HOSPITAL POLICY. ASSOCIATED WITH 1038671-2021-00332.

  Patient problems: Failure of Implant

  MAUDE report 12545727 ↗