GLOBAL ADVANTAGE 1128-40-000Recalls & reported problems
Depuy Orthopaedics, Inc. · GLOBAL ADVANTAGE HUMERAL HEAD SIZE 40mm x 15mm · Class 2 · Implant
All models of GLOBAL ADVANTAGE (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295005063), received between Oct 29, 2018 and Sep 4, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Loss of or Failure to Bond1
Patient problems
- No Code Available3
- Pain1
- Unspecified Tissue Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF IMPLANTS AND CONVERTING TO A REVERSE. THERE WAS NO LOOSENING, AND THERE WAS NOTHING WRONG WITH IMPLANTS. THERE WAS ALSO SUBSCAPULARIS MUSCLE FAILURE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 20135270 ↗InjuryJun 30, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO MECHANICAL LOOSENING AND ROTATOR CUFF TEAR. LOT NUMBER IS NOT LEGIBLE ON THE GLENOID COMPONENT. NO OTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT SHOULDER.
Patient problems: No Code Available
MAUDE report 10214556 ↗InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS LOST FUNCTION OF SUBSCAP AND WAS CONVERTED TO A REVERSE SHOULDER FROM ANOTHER COMPANY. COULD NOT GET A COMPLETE SET OF RECORDS. PATIENT HAD TOTAL SHOULDER DONE IN 2010. DOI: (B)(6) 2010; DOR: (B)(6) 2019 RIGHT SHOULDER.
Patient problems: No Code Available
MAUDE report 9577416 ↗InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS INSTABILITY AND PAIN.
Patient problems: No Code Available; Pain
MAUDE report 8013750 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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