Shoulder System 04.01.0127Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630040706346), received between May 29, 2019 and Mar 31, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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. How this data works · Data updated Oct 13, 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.

• InjuryMar 31, 2026Device Dislodged or Dislocated

  REVISION SURGERY DUE TO INSTABILITY ABOUT 4 MONTHS AFTER LAST REVISION SURGERY AND THE CAUSE IS UNKNOWN. NO TRAUMA WAS REPORTED. THE SURGEON REMOVED THE SPHERE AND CHECKED THE BASEPLATE FOR LOOSENESS, BUT IT WAS SECURE. THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD PRIMARY ON (B)(6) 2023. ON (B)(6) 2025 FIRST REVISION DUE TO STIFFNESS. ON (B)(6) 2025 SECOND REVISION SURGERY DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 24738811 ↗
• InjuryFeb 26, 2026Device Dislodged or Dislocated

  AT ABOUT 1 YEAR AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN ASSOCIATED WITH A DISLOCATION OF THE GLENOSPHERE AND THE POLY. THE CAUSE IS UNKNOWN AS THERE IS NO TRAUMA REPORTED. THE SURGEON REVISED THE METAPHYSIS FROM +0/0° TO +9/0° THE LINER TO A LINER OF THE SAME SIZE, AND THE GLENOSPHERE TO A GLENOSPHERE OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24454885 ↗
• InjuryAug 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2023. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE AND LINER, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. (MDR 2023-01105) ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. (MDR 2024-00134) ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. (MDR 2024-00693) PRESENTLY, ON (B)(6) 2025, AT ABOUT 1 YEAR AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED ONLY THE LINER, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22770679 ↗
• InjuryFeb 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT ONE WEEK AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 21408530 ↗
• InjuryJun 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY DUE TO DISLOCATION (LINER-GLENOSPHERE). ALL COMPONENTS REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 19583551 ↗
• InjuryJun 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 WEEK AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS, BASEPLATE, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 19517429 ↗
• InjuryNov 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15869298 ↗
• InjuryMay 29, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  ON (B)(4) 2019 WE WERE INFORMED OF A SHOULDER DISLOCATION, THE GLENOSPHERE DISLOCATED FROM THE LINER. THE PATIENT HAS BEEN REVISED ON (B)(6) 2019, AFTER ABOUT 5 WEEKS FROM THE PRIMARY SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 8649825 ↗