GLOBAL ADVANTAGE 1128-44-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295005124), received between Aug 24, 2017 and Jan 11, 2024 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER SHOULDER REPLACED APPROXIMATELY IN 2010 BY SURGEON WHERE SHE HAD A GLOBAL ADVANTAGE SHOULDER PROSTHESIS. THE PATIENT DID WELL UNTIL THE LAST YEAR WHERE SHE HAS CUFF TEAR ARTHROPATHY AND LOST MOBILITY AND BECAME PAINFUL. SURGEON AND THE PATIENT MADE THE DECISION TO EXPLANT THE GLOBAL CONSTRUCT AND IMPLANT AN INHANCE REVERSE CONSTRUCT. A HUMERAL STEM, HEAD, AND GLENOID WERE EXPLANTED. THE CATALOGUE AND LOT NUMBER FOR THE HUMERAL STEM AND GLENOID WERE NOT DOCUMENTED BECAUSE THE INFORMATION WAS ILLEGIBLE. ACTIVITY LEVEL - YES. DOI: 2010. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 18491899 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SOFT TISSUE INJURY, HAD TO CONVERT TO REVERSE 44X18 HEAD AND 8MM GLOBAL ADV STEM. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(3) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18291995 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 12869277 ↗
• InjuryJun 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2015, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Joint Dislocation; No Code Available; Pain

  MAUDE report 8713145 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. CONVERTED TO COMPETITOR COMPONENTS WITH LATERALIZED OPTIONS. DOI: (B)(6) 2010, DOR: (B)(6) 2019, LEFT SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 8520587 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAINFUL HEMI WITH POTENTIAL CUFF DEFICIT. DOI: UNK DOR: (B)(6) 2019 LEFT SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 8482096 ↗
• InjuryDec 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8160017 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNK; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Not Applicable; Pain

  MAUDE report 7865703 ↗
• InjuryDec 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ALL COMPONENTS WERE REMOVED. THE PATIENT HAD PAIN, REDUCED RANGE OF MOTION AND SEVERE WEAR OF THE GLENOID BONE. A CEMENT SPACER WAS INSERTED AND WILL BE REVISED AT A LATER STAGE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7133612 ↗
• InjuryDec 12, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION OF SHOULDER SEVERAL TIMES. STEM, HEAD, GLENOID WERE REMOVED AND A (B)(4) REVERSE WAS IMPLANTED. DOI: (B)(6) 2014; DOR: (B)(6) 2017; LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 7107543 ↗
• MalfunctionNov 13, 2017Incorrect Measurement; Incorrect Measurement

  DER STATES THAT THE IMPLANTS WERE SITTING TOO PROUD SO REMOVED AND REPLACED. PER FOLLOW-UP, IMPLANT ALLEGEDLY OVERSIZED.

  Patient problems: No Information

  MAUDE report 7025375 ↗
• InjuryAug 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6816803 ↗