Shoulder System 04.01.0187Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040715959), received between Sep 1, 2021 and Sep 9, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  At about 1 month from the primary, the patient came in presenting pain due to a fractured humerus and the cause is unknown. The surgeon revised the reverse metaphysis from +0mm/0° to +9mm/0°, revised the rev. constrained E-CROSS liner D 39/+6 to a reverse HC liner D 39/+3mm, and revised the Short humeral diaphysis - Cementless - 14 to a Long humeral diaphysis - L200 - 13. The surgery was completed successfully.

  Patient problems: Bone Fracture(s)

  MAUDE report 50692288 ↗
• InjuryMay 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 7 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED DUE TO INFECTION. SURGERY COMPLETED SUCCESSFULLY. ALL SHOULDER DEVICES REVISED.

  Patient problems: Medical device site infection

  MAUDE report 21974457 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem

  1-YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON REVISED ALL IMPLANTS DUE TO INFECTION OF BACTERIA (PROPIONIBACTERIUM).

  Patient problems: Bacterial Infection

  MAUDE report 12406281 ↗