GLOBAL ADVANTAGE 1128-52-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295005193), received between May 31, 2018 and Apr 15, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MAUDE REPORT RECEIVED. IT WAS REPORTED THAT THE PATIENT RECEIVED A LEFT HEMI SHOULDER ARTHROPLASTY WITH A DEPUY SYNTHES GLOBAL ADVANTAGE SYSTEM INVOLVING A 52MM GLOBAL ADVANTAGE COCR HUMERAL HEAD AND SIZE 8 GLOBAL ADVANTAGE STANDARD STEM. ON 2017, SHE EXPERIENCED SUDDEN AND NEW ONSET OF FATIGUE, DYSPNEA, CONFUSION, POLYNEUROPATHY, BALANCE ISSUES, HEADACHES, TINNITUS, VISION AND HEARING ISSUES, WORD FINDING ISSUES, TREMOR/CHANGES IN HANDWRITING, MOOD CHANGES, AND DIFFICULTY WITH MULTITASKING. THE HUMERAL STEM WAS REVISED BECAUSE DEPUY DID NOT HAVE A NON-COBALT HEAD OPTION. THE GLENOID HAD SIGNIFICANT POSTERIOR EROSION BUT ADEQUATE BONE REMAINED FOR RESURFACING WITH THE POSTERIORLY AUGMENTED CORTILOCK SMALL GLENOID. PATHOLOGY REPORT OF FROZEN SECTION OF LEFT SHOULDER SYNOVIAL TISSUE NOTABLE FOR SIGNS OF CHRONIC INFLAMMATION INCLUDING MILD TO MODERATE LYMPHOHISTIOCYTIC INFLAMMATION AND DENSE CHRONIC PERIVASCULAR LYMPHOCYTIC INFLAMMATION (ALVAL). COBALT LEVEL OF LEFT SHOULDER FLUID WAS 64 MCG/L AND CHROMIUM LEVEL WAS 78 MCG/L, HER BLOOD AND URINE COBALT LEVELS INITIALLY DROPPED FOLLOWING REVISION OF THE LEFT SHOULDER. DOI: (B)(6) 2015. DOR: (B)(6) 2018. LEFT SHOULDER.

  Patient problems: Ambulation or Postural Difficulties; Dyspnea; Fatigue; Foreign Body Reaction; No Code Available

  MAUDE report 9963425 ↗
• InjuryMay 31, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT PATIENT WAS REPORTED TO HAVE HIGH LEVELS OF COCR, SYMPTOMS DESCRIBED BY PHYSICIAN. DOI: UNKNOWN. DOR: (B)(6) 2018. LEFT SHOULDER.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7556564 ↗