GLOBAL ICON 1140-20-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295381235), received between Jul 9, 2020 and Apr 6, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 18, 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.

• MalfunctionApr 6, 2026Incomplete or Missing Packaging; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT INTRAOPERATIVELY IN PRESENCE OF THE DPS SALES REP THE SHRINK-WRAPPED PRODUCT WAS OPENED. INSIDE BOTH STERILE PACKAGES WERE ALREADY OPENED AND THE IMPLANT WAS FOUND TO BE IN THE PACKAGE WITHOUT THE ELASTIC "SOCK". ANOTHER IMPLANT WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, NOR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789299 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RAISED CRP LAB RESULT EVENT IS NOT SERIOUS AND IS CONSIDERED MILD EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT SHOULDER) TREATMENT: NONE.

  Patient problems: Cardiac Arrest; Unspecified Infection

  MAUDE report 14713535 ↗
• InjuryJul 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS AN IMPLANT LOOSENING OF THE GLENOID COMPONENT. THE IMPLANT WAS FULLY INTACT AND WELL POSITIONED. LOOSENING MIGHT HAVE BEEN RELATED TOT HE SUSPECTED OVERSTUFFED NATURE OF THE JOINT.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10251640 ↗