GLOBAL ADVANTAGE 1128-48-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295005155), received between Apr 29, 2019 and Jul 14, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FAILED ROTATOR CUFF. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25814904 ↗
• InjuryMay 4, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT GLOBAL ADVANTAGE IMPLANTS WERE REVISED DUE TO THE PATIENT HAVING MULTIPLE DISLOCATIONS. THE ANATOMIC IMPLANTS WERE REPLACED WITH ENHANCE REVERSE IMPLANTS. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. PROCEDURE WAS SMOOTH AND WENT ACCORDING TO PLAN. DOI: (B)(6) 2012. DOR: UNKNOWN. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 25069534 ↗
• InjuryMay 4, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE GLOBAL ADVANTAGE IMPLANTS WERE REVISED DUE TO THE PATIENT HAVING MULTIPLE DISLOCATIONS. THE ANATOMIC IMPLANTS WERE REPLACED WITH ENHANCE REVERSE IMPLANTS. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. PROCEDURE WAS SMOOTH AND WENT ACCORDING TO PLAN. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025. DOR: UNKNOWN. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 25069333 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ROTATOR CUFF TORE AFTER HAVING A HEMI SHOULDER REPLACEMENT DUE TO A PROXIMAL HUMERAL RESECTION IN DEC 2018. IMPLANT WAS CONVERTED TO A REVERSE SHOULDER IMPLANT. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24801052 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HUMERAL HEAD WAS REMOVED AND REPLACED WITH A CTA BECAUSE OF INSUFFICIENT ROTATOR CUFF. ORIGINAL DATE OF SURGERY WAS UNKNOWN, BUT IT WAS MENTIONED TO BE 20+ YEARS AGO.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22954758 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 19703957 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD WAS EXCHANGED TO DECREASE THICKNESS, NO OTHER INFORMATION PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 18747246 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DEFICIENT ROTATOR CUFF AND STEM LOOSENING. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18173114 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED IN CLINIC WITH PAINFUL RIGHT SHOULDER SURGEON HAD REPLACED IN (B)(6) 2003 AT (B)(6) HOSPITAL. PATIENT ALSO EXHIBITED LOSS OF FUNCTION IN RIGHT SHOULDER SO THE DOCTOR ELECTED TO PERFORM A REVISION SURGERY ON PATIENT¿S RIGHT SHOULDER. PERFORMED REVISION SURGERY ON (B)(6) 2019 AT (B)(6) HOSPITAL. SURGEON REMOVED THE GLENOID, HUMERAL STEM, AND HUMERAL HEAD WITH INSTRUMENTATION. HE THEN ELECTED TO IMPLANT A REVERSE SHOULDER PROSTHESIS USING COMPETITIVE SYSTEMS.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9519671 ↗
• InjuryApr 29, 2019Fitting Problem; Fitting Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE GLENOID COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE HUMERAL HEAD WAS ALSO REVISED TO A LARGER ONE TO PROVIDE MORE BONY COVERAGE. DOI: (B)(6) 2017, DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available

  MAUDE report 8560048 ↗