GLOBAL ADVANTAGE 1128-44-000Recalls & reported problems
Depuy Orthopaedics, Inc. · GLOBAL ADVANTAGE HUMERAL HEAD SIZE 44mm 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295005094), received between Sep 15, 2017 and May 8, 2023 — classified as 6 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Insufficient Device Problem Information2
- Separation Problem1
Patient problems
- No Code Available3
- Pain2
- Discomfort1
- Joint Disorder1
- Joint Laxity1
- Loss of Range of Motion1
- Not Applicable1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INSTABILITY. REVISION NECESSARY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 16885910 ↗InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS POSSIBLE INFECTION AND INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT SHOULDER.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10683307 ↗InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS DISCOMFORT AND LIMITED RANGE OF MOTION. ALL IMPLANTS WERE REMOVED. THE STEM WAS WELL FIXED BUT THE GLENOID HAD A LOT OF POSTERIOR WEAR. A REVERSE SHOULDER WAS IMPLANTED. DOI: (B)(6) 2016; DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.
Patient problems: Discomfort; Loss of Range of Motion; No Code Available
MAUDE report 8897990 ↗InjuryJan 2, 2019Separation Problem; Separation Problem
PATIENT REVISED DUE TO DISASSOCIATION OF IMPLANTS.
Patient problems: No Code Available
MAUDE report 8208814 ↗InjuryAug 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION (L) HEMI ARTHROPLASTY TO REVERSE. REVISION TSR - ORIGINAL HEMIARTHROPLASTY (GLOBAL ADVANTAGE) PERFORMED BY ANOTHER SURGEON IN 2003. NO FURTHER INFO AVAILABLE. PATIENT COMPLAINING OF INCREASING PAIN OVER THE PAST 3 YEARS. SURGEON REMOVED THE GLOBAL ADVANTAGE HEMI & REPLACED WITH DJO REVERSE. SHOULDER EXTRACTION INSTRUMENTS PROVIDED. SURGEON HAD SOME DIFFICULTY REMOVING THE HUMERAL STEM DUE TO PROXIMAL CEMENT.
Patient problems: Not Applicable; Pain
MAUDE report 7762343 ↗InjurySep 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.
Patient problems: Joint Disorder; Pain
MAUDE report 6868787 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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.
How reports and recalls are matched · Editorial policy · Report an error on this page