GLOBAL UNITE 1407-20-103Recalls & reported problems
Depuy (Ireland) · GLOBAL UNITE PLATFORM SHOULDER SYSTEM REVERSE FX EPI RIGHT POROCOAT · Class 2 · Implant
All models of GLOBAL UNITE (91)
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 10603295446682), received between Jul 16, 2019 and Jul 30, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).
8 other recalls cover devices cleared under the same FDA submission (K170748); they may or may not involve this specific model.
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
- Inadequacy of Device Shape and/or Size1
- Patient-Device Incompatibility1
Patient problems
- Loss of Range of Motion1
- No Consequences Or Impact To Patient1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had limited range of motion. Upon revision, the stem was found to be loose in its cement mantle. All components but the metaglene and screws were revised. It was stated that humeral stem was loose. Loosening interface was marked as cement to implant. Cement manufacturer was marked as DePuy Synthes. DOI: (b)(6) 2026.DOR: (b)(6)2026.Affected side: Right shoulder.
Patient problems: Loss of Range of Motion
MAUDE report 50091006 ↗InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE METAGLENE AT THE BONE TO IMPLANT INTERFACE. ALL IMPLANTS WERE REMOVED AND PLACEMENT OF SPACER WAS PERFORMED. DOI: (B)(6) 2019; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 16254911 ↗MalfunctionJul 16, 2019Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility
IT WAS REPORTED THAT THE REVERSE FOX EPIPHYSIS WOULD NOT FIT INTO THE BONE MANTLE CREATED. SURGEON DID NOT WANT TO USE IT AND ELECTED TO USE THE REGULAR EPIPHYSIS INSTEAD. DOE: (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8792893 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K170748. One submission often covers many models, so check the product and lot details in each record.
- Z-0490-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
- Z-0485-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
- Z-0488-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
- Z-0487-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
- Z-0483-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
- Z-0486-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
- Z-0489-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
- Z-0484-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
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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