Shoulder System 04.01.0184Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630040715928), received between Sep 5, 2023 and Aug 28, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 4 YEARS AND 11 YEARS, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22911272 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2023 THE PATIENT UNDERWENT A TSA, THE SURGEON AIMED AT IMPLANTING A REVERSE SHOULDER BUT THE IMPLANTATION FAILED DUE TO POOR GLENOID BONE STOCK. THE SURGEON CONVERTED THE SURGERY IN A HEMI-ARTHROPLASTY. IN (B)(6) 2025 THE PATIENT REPORTED PAIN OF UNKNOWN CAUSE, THE SURGEON REVISED THE PATIENT TO A REVERSE SHOULDER (COMPETITOR IMPLANTS). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22017270 ↗
• InjuryMay 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 MONTHS FROM PRIMARY, THE PATIENT HAS UNDERGONE REVISION DUE TO INFECTION. THE SURGEON REVISED ALL COMPONENTS SUCCESSFULLY

  Patient problems: Medical device site infection

  MAUDE report 21974540 ↗
• InjuryFeb 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AT ABOUT 3 MONTHS FROM SURGERY, PART OF CLINAL STUDY. SURGEON REVISED ALL COMPONENTS.

  Patient problems: Medical device site infection

  MAUDE report 21353185 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO STEM BREACHING THE LATERAL CORTEX. THE STEM WAS FOUND TO BE WELL FIXED. HOWEVER, IN ORDER TO ALLEVIATE THE PAIN, THE SURGEON REMOVED ALL THE COMPONENTS AND CONVERTED THE PATIENT FROM A PRIMARY TO A REVERSE SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 21157356 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE SHOULDER SURGERY OF THE (B)(6) 2022, A FRACTURE OF THE METAPHYSIS OF THE HUMERUS OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY PERFORMING A CERCLAGE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17681449 ↗