Shoulder System 04.01.0400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630542714627), received between Jan 10, 2025 and Sep 30, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Osseointegration Problem

  The patient had primary right shoulder surgery on (b)(6) 2022.On (b)(6) 2023, the patient came in reporting pain due to a malpositioned baseplate and the cause of the malpositioned baseplate is unknown. The surgeon revised the baseplate, glenosphere and liner. The surgery was completed successfully. (b)(4).On (b)(6) 2026, the patient came in reporting pain due to a loose baseplate due to poor bone quality. The surgeon revised the baseplate, the glenosphere and the liner. The surgery was completed successfully.Presently, on (b)(6) 2026 the patient came in reporting pain due to a loose baseplate and the cause is unknown. The surgeon revised the reverse HC liner Ø42/+6mm to a rev. constrained E-CROSS liner Ø42/+0, revised the Ø42x24.5 glenosphere to a same size glenosphere, and revised the Ø24.5x20 - Full wedge 10° baseplate to a same size baseplate. The surgery was completed successfully.

  Patient problems: Aseptic loosening

  MAUDE report 50946796 ↗
• InjuryFeb 26, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY RIGHT SHOULDER ON (B)(6) 2019 WITH AN ANATOMICAL SHOULDER SYSTEM. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A FAILED ROTATOR CUFF AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT FROM AN ANATOMIC SHOULDER TO REVERSE SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA IMPLANTS AND IMPLANTED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24454902 ↗
• InjuryDec 18, 2025Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME REPORTING PAIN DUE TO A LOOSE BASEPLATE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE ALL COMPONENTS EXCEPT THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23837336 ↗
• InjuryJan 10, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE GLENOID BASEPLATE AND THE CAUSE IS UNKNOWN. ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE BASEPLATE, LINER, METAPHYSIS, GLENOSPHERE, AND SCREWS (METAPHYSIS WAS REMOVED TO ACCESS THE GLENOID COMPONENTS). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21122215 ↗