GLOBAL ADVANTAGE 1128-44-020Recalls & reported problems
Depuy Orthopaedics, Inc. · GLOBAL ADVANTAGE HUMERAL HEAD SIZE 44mm x 21mm · Class 2 · Implant
All models of GLOBAL ADVANTAGE (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295005117), received between May 31, 2019 and Feb 18, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Patient-Device Incompatibility1
Patient problems
- Joint Dislocation1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. THE PATIENT WAS TREATED WITH THE CEMENTED FRACTURE STEM IN (B)(6) OF 2020. THERE WERE NO OTHER SURGERIES. SURGEON STATED THAT SHE WOULD DISLOCATE UPON EXTERNAL ROTATION. REVISED TO A CEMENTED DELTA EXTEND. FRACTURE STEM WAS REMOVED AND REPLACED WITH CEMENTED DELTA REVERSE. NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 11342668 ↗MalfunctionMay 31, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED A 44X21 STANDARD HUMERAL GLOBAL ADVANTAGE HEAD WAS REMOVED DUE TO THE ROTATOR CUFF RUBBING TIGHTLY OVER THE IMPLANT. IT WAS DETERMINED THAT THE HUMERAL HEAD WAS TO LARGE AND OVERSTUFFED THE JOINT CAPSULE, SO A NEW/SMALLER GLOBAL ADVANTAGE HEAD (40X18) WAS PUT IN. NO LOT NUMBER WAS AVAILABLE BECAUSE IT WAS UNREADABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8658115 ↗
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.
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