Shoulder System 04.01.0111Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630040706186), received between Dec 15, 2017 and Nov 28, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT HAD PRIMARY LEFT SHOULDER SURGERY. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING A WITH TIGHT SHOULDER AND LIMITED MOBILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY (B)(4). ON (B)(6) 2025, THE PATIENT CAME IN REPORTING STABILITY ISSUES AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS AND UPSIZED THE LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23669504 ↗
• InjuryJul 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 5 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER, METAPHYSIS, AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22664404 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2024. ON (B)(6) 2024, 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 METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS, AND LINER. THER SURGERY WAS COMPLETE SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21771468 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS AND LIMITED MOBILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21617414 ↗
• InjuryApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 3 YEARS AND 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19059643 ↗
• InjuryMar 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR GLENOSPHERE AND MEDACTA METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16596968 ↗
• InjuryOct 19, 2021Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING LATERAL INSTABILITY AND THE CAUSE OF THE INSTABILITY IS LAXITY. ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12655740 ↗
• InjuryDec 15, 2017Device Dislodged or Dislocated

  REVISION SURGERY WAS NECESSARY DUE TO LUXATION.

  Patient problems: Joint Dislocation

  MAUDE report 7120560 ↗