Shoulder System 04.01.0401Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630542714634), received between Aug 29, 2025 and Jul 14, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryJul 14, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AFTER 3 MONTHS FROM THE PRIMARY DUE TO A LOOSE GLENOID CAUSED BY A SUSPECTED INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE PATIENT TO A HEMI. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25813731 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING PAIN DUE TO A BASEPLATE THAT WAS IMPLANTED TOO SUPERIOR ON THE GLENOID FACE DURING THE PRIMARY SURGERY. ABOUT 5 MONTHS AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE BASEPLATE AND GLENOSPHERE TO A COMPETITOR BASEPLATE AND GLENOSPHERE, AND THE LINER TO A REV. CONSTRAINED E-CROSS LINER D 36/+0. THE MEDACTA STEM REMAINED AS IT WAS WELL FIXED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 25313932 ↗
• InjuryJan 23, 2026Loosening of Implant Not Related to Bone-Ingrowth; Migration

  DURING A POST-OPERATION FOLLOW UP AT 1 YEAR FROM PRIMARY, THE SURGEON DISCOVERED THAT THE BASEPLATE HAD MIGRATED AFTER THE PATIENT`S PRIMARY LEFT SHOULDER SURGERY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE BASEPLATE TO A THREADED BASEPLATE, THE GLENOSPHERE AND METAPHYSIS TO A SAME SIZE GLENOSPHERE AND METAPHYSIS, AND REVISED THE LINER TO A REVERSE CONSTRAINED LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24162769 ↗
• InjuryAug 29, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT PRESENTED WITH PAIN DUE TO A FAILED SUBSCAPULARIS MUSCLE, THE CAUSE OF WHICH WAS UNKNOWN. THE SURGEON REVISED THE IMPLANT FROM AN ANATOMIC SHOULDER TO A REVERSE SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT AGAIN PRESENTED WITH PAIN, THIS TIME DUE TO A LOOSE BASEPLATE, WITH THE CAUSE REMAINING UNKNOWN. THE SURGEON REVISED THE REVERSE SHOULDER TO A HEMI SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 22922921 ↗