Shoulder System 04.01.0116Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630040706230), received between Dec 5, 2019 and Jul 10, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA OR A FALL. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LAT. GLENOSPHERE 32XD 24.5 TO A LAT. GLENOSPHERE 39XD 24.5 AND REVISED THE REVERSE HC LINER D 32/+0MM TO A CONSTRAINED E-CROSS LINER D 39/+3 TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25778121 ↗
• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO JOINT LUXATION BETWEEN LINER AND COMPETITOR GLENOSPHERE AFTER ABOUT 1 YEAR AND 4 MONTHS FROM PRIMARY. THE SURGEON REVISED LINER AND METAPHYSIS.

  Patient problems: Joint Dislocation

  MAUDE report 25747737 ↗
• InjuryMar 31, 2026Device Dislodged or Dislocated

  REVISION SURGERY DUE TO INSTABILITY ABOUT 8 MONTHS AFTER PRIMARY SURGERY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA IMPLANTS (METAPHYSIS, LINER, DIAPHYSIS, GLENOSPHERE, AND BASEPLATE) TO COMPETITOR IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24741263 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT ONE MONTH AND A HALF FROM PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE D 32 LINER TO A D 36+6 CONSTRAINED LINER, AND REVISED THE 32XD 24.5 GLENOSPHERE TO A 36XD 24.5 GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24399529 ↗
• InjuryMar 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON THE (B)(6) 2025 THE PATIENT UNDERGONE REVERSE SHOULDER ARTHROPLASTY. ON THE (B)(6) 2025 THE PATIENT UNDERGONE REVISION SURGERY DUE TO JOINT LUXATION, LINER, DIAPHYSIS AND METAPHYSIS REVISED. ON THE (B)(6) 2025 THE PATIENT UNDERGONE A SECOND REVISION SURGERY DUE TO JOINT LUXATION, LINER, METAPHYSIS AND GLENOSPHERE REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 21709024 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 2 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE PATIENT BY CONVERTING THE REVERSE SHOULDER TO A HEMI-SHOULDER ARTHROPLASTY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16813631 ↗
• InjurySep 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN THE EMERGENCY ROOM REPORTING PAIN DUE TO DISLOCATION AND THE CAUSE IS UNKNOWN. THE EMERGENCY ROOM DOCTOR REDUCED THE PATIENT AND PUT HER IN A SHOULDER SLING. WHEN THE PATIENT WENT TO A VISIT WITH THE OPERATING SURGEON, HE WAS PLANNING ON CEMENTING A NEW STEM, BUT AFTER OPENING THE PATIENT HE DECIDED THAT THE STEM WAS SOLID AND WAS NOT GOING TO SUBSIDE. THE SURGEON REVISED LINER FROM A +0 TO +6. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15518430 ↗
• InjuryDec 5, 2019Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A SHOULDER DISLOCATION 1 MONTH AFTER PRIMARY. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NEW LINER: HUMERAL REVERSE HC LINER Ø32/+6MM.

  Patient problems: Joint Dislocation

  MAUDE report 9416218 ↗