Shoulder System 04.01.0209Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630040728089), received between May 3, 2023 and Feb 26, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY SHOULDER SURGERY ON (B)(6) 2022. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE BASEPLATE WAS LEFT IN PLACE. NEW SCREWS AND A NEW GLENOSPHERE WERE IMPLANTED, WHILE THE HUMERAL COMPONENT WAS FROM A COMPETITOR. THE SURGERY WAS COMPLETED SUCCESSFULLY (EMDR (B)(4). PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GLENOSPHERE TO A SAME SIZE GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24454890 ↗
• InjuryApr 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2019. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A FAILED ANATOMIC SHOULDER AFTER FALLING. THE SURGEON CONVERTED THE PATIENT TO A REVERSE SHOULDER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION AFTER MOVING FURNITURE. THE EFFORT IS REPORTED TO BE A NORMAL ONE, NOT ANYTHING RISKY. THE SURGEON REVISED THE METAPHYSIS, GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO PERSISTENT SUBLUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT TO A SALVAGE HEMI ARTHROPLASTY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21889978 ↗
• InjuryJun 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2023. 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. ON (B)(6) 2024 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 LINER, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, 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 GLENOSPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19481303 ↗
• InjuryMay 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT CAME REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE LINER AND GLENOSPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME 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: Implant Pain

  MAUDE report 16859024 ↗