GLOBAL ADVANTAGE 1128-44-010Recalls & reported problems
Depuy Orthopaedics, Inc. · GLOBAL ADVANTAGE HUMERAL HEAD SIZE 44mm x 18mm · Class 2 · Implant
All models of GLOBAL ADVANTAGE (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295005100), received between Aug 30, 2019 and Apr 13, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 Problem2
- Patient-Device Incompatibility1
Patient problems
- Unspecified Tissue Injury2
- Adhesion(s)1
- Loss of Range of Motion1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A SUBSCAP FAILURE. SURGEON CONVERTING ANATOMIC SHOULDER TO A REVERSE SHOULDER. NO KNOWN INFECTION, NO DELAY IN SURGERY, UNKNOWN LOT NUMBERS. DOI- (B)(6) 2018. DOR- (B)(6) 2026. AFFECTED SIDE- LEFT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 24859550 ↗InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD A TOTAL SHOULDER IN 2017. OVER THE LAST 6 MONTHS, PATIENT HAS PRESENTED WITH DECREASING RANGE OF MOTION. SURGEON CONSULTED PEERS. PATIENT WAS TAKEN TO THE OR. SURGEON REMOVED THE 44X18 HEAD, DID A CAPSULAR RELEASE, REMOVED SCAR TISSUE AND SOME BONE , REPLACED NEW 44X18 HEAD. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Adhesion(s); Loss of Range of Motion; Unspecified Tissue Injury
MAUDE report 15520292 ↗MalfunctionAug 30, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT HAD A PROSTHETIC OVERHANG OF THE HUMERAL HEAD IMPLANT. THE SURGEON ELECTED TO USE AN ECCENTRIC HEAD TO IMPROVE THE COVERAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8951187 ↗
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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