GLOBAL ADVANTAGE 1137-08-000Recalls & reported problems
Depuy Orthopaedics, Inc. · GLOBAL ADVANTAGE STANDARD STEM SIZE 8 133mm · Class 2 · Implant
All models of GLOBAL ADVANTAGE (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295007081), received between May 11, 2018 and Apr 1, 2025 — classified as 8 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 Problem5
- Appropriate Device Problem Term/Code Not Available1
- Improper or Incorrect Procedure or Method1
- Loose or Intermittent Connection1
- Use of Device Problem1
Patient problems
- Pain3
- No Code Available2
- Not Applicable2
- Unspecified Tissue Injury2
- Insufficient Information1
- Limited Mobility Of The Implanted Joint1
- Loss of Range of Motion1
- Unspecified Infection1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ROTATOR CUFF TEAR OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 21743557 ↗InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO SOFT TISSUE INJURY. HAD TO CONVERT TO REVERSE 44X18 HEAD AND 8MM GLOBAL ADV STEM. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023 AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 18291032 ↗InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 14, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method
IMPLANTS REMOVED DURING REVISION - BELIEVED TO BE DUE TO POOR PLACEMENT OF HUMERAL STEM IN TOO MUCH ANTEVERSION.
Patient problems: Insufficient Information
MAUDE report 11827044 ↗InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT PRESENTED IN CLINIC WITH PAINFUL RIGHT SHOULDER SURGEON HAD REPLACED IN (B)(6) 2003 AT (B)(6). PATIENT ALSO EXHIBITED LOSS OF FUNCTION IN RIGHT SHOULDER SO THE DOCTOR ELECTED TO PERFORM A REVISION SURGERY ON PATIENT¿S RIGHT SHOULDER. PERFORMED REVISION SURGERY ON (B)(6) 2019 AT (B)(6). SURGEON REMOVED THE GLENOID, HUMERAL STEM, AND HUMERAL HEAD WITH INSTRUMENTATION. HE THEN ELECTED TO IMPLANT A REVERSE SHOULDER PROSTHESIS USING COMPETITIVE SYSTEMS.
Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain
MAUDE report 9519695 ↗InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 7793685 ↗InjuryMay 31, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DER STATES THAT PATIENT WAS REPORTED TO HAVE HIGH LEVELS OF COCR, SYMPTOMS DESCRIBED BY PHYSICIAN. DOI: UNKNOWN. DOR: (B)(6) 2018. LEFT SHOULDER.
Patient problems: No Code Available; Not Applicable
MAUDE report 7556548 ↗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 7507257 ↗
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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