GLOBAL 1137-95-026Recalls & reported problems
Depuy Orthopaedics, Inc. · GLOBAL KEELED GLENOID PREMIERON X-LINKED PE 44mm · Class 2 · Implant
All models of GLOBAL (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295007401), received between May 11, 2018 and May 26, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
- Loss of or Failure to Bond1
Patient problems
- Insufficient Information1
- Loss of Range of Motion1
- Not Applicable1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2021Loss of or Failure to Bond; Loss of or Failure to Bond
THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE GLENOID AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. THE SURGEON FOUND THE KEELED GLENOID FLOATING AROUND INSIDE THE JOINT AND REMOVED IT. UPON EXAMINING THE OTHER IMPLANTS, IT WAS DETERMINED THAT THE PATIENT HAD A FUNCTIONING HEMI ARTHROPLASTY SO THE SURGEON LEFT ALL THE IMPLANTS AS THEY WERE ALL FIXED. DOI: (B)(6) 2015. DOR: (B)(6) 2021. LEFT SHOULDER.
Patient problems: Insufficient Information
MAUDE report 11891558 ↗InjuryMay 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE SHOULDER AND SURROUNDING REGIONS, LOSS OF RANGE OF MOTION AND LOOSENING OF THE COMPONENTS. DOI: (B)(6) 2015; DOR: (B)(6) 2017 ;(RIGHT SHOULDER).
Patient problems: Loss of Range of Motion; Not Applicable; Pain
MAUDE report 7507260 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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