GLOBAL ADVANTAGE 1128-56-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295005254), received between Mar 20, 2018 and Jul 7, 2025 — classified as 6 injuries.

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

• InjuryJul 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAS A HISTORY OF MULTIPLE DISLOCATION WITH CLOSED REDUCTION. LAST CLOSED REDUCTION KNOCKED THE GLENOID COMPONENT LOOSE. THERE WAS GLENOID LOOSENING AT THE CEMENT/IMPLANT INTERFACE AND COMPETITOR CEMENT WAS USED. SURGEON REMOVED THE GLENOID COMPONENT AND 52 18 STD HEAD AND PUT IN 52 18 ECC HEAD WITH POSTERIOR ECCENTRICITY AS TENDENCY TO POP OUT ANTERIORLY. THE STEM WAS WELL FIXED. TREATED LIKE REAM AND RUN DID NOT THE REIMPLANT THE GLENOID. THIS OCCURRED ON THE LEFT SIDE. THERE WAS NO BROKEN IMPLANTS. THE PAST DISLOCATIONS WERE WHAT WAS REVISED IN THIS SURGERY. ALL PARTS OF THE HEAD AND GLENOID WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22413137 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE PRODUCT WAS UNSTABLE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21654011 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SUBSCAP REPAIR WAS DONE. DOI: UNKNOWN ; DOR: (B)(6) 2021 RIGHT SHOULDER.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 12777877 ↗
• InjuryNov 7, 2018Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HUMERAL HEAD IS CHANGED DUE TO PREVIOUS HUMERAL FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8048133 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN INCREASED PAIN OVER YEARS OF IMPLANTED HEMIARTHROPLASTY. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT SHOULDER.

  Patient problems: Not Applicable; Pain

  MAUDE report 7841656 ↗
• InjuryMar 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAINFUL HEMI ON THE LEFT SIDE. IT WAS ALSO INDICATED THAT MULTIPLE ANCHORS REMOVED FROM GLENOID VAULT AND ATTEMPTED GLENOID PREP WAS REPLACED WITH BONE GRAFTING DUE TO INSUFFICIENT BONE STOCK. HUMERAL HEAD REPLACED WHILST IN THE JOINT. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN SIDE OF SHOULDER. NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 7352408 ↗