GLOBAL UNITE 1100-40-120Recalls & reported problems
Depuy (Ireland) · GLOBAL UNITE EPIPHYSIS BODY POROCOAT SIZE 12 +5 · Class 2 · Implant
All models of GLOBAL UNITE (91)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295004462), received between Oct 25, 2018 and Oct 25, 2018 — classified as 1 injury.
8 other recalls cover devices cleared under the same FDA submission (K101996, 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SHOULDER REPLACEMENT: (B)(6), (B)(6), (B)(6) 2018. ORIGINAL CASE: (B)(6) 2017, (B)(6), SURGEON: (B)(6). REASON FOR REVISION: PAIN AND LACK OF FUNCTION. CONVERSION OF UNITE FRACTURE STEM TO DELTA EXTEND. REMOVED FRACTURE BODY AND HEAD, AND CONVERTED TO STANDARD DELTA EPI 1 LEFT, 38/3 HIGH MOBILITY STANDARD METAGLENE, AND 38 ECCENTRIC HEAD. WAS EXTREMELY HARD TO REDUCE, MAINLY AS ORIGINAL CASE LOOKED LIKE IT HAD BEEN CEMENTED TOO HIGH. FEMALE PATIENT INITIALS (B)(6), AGED (B)(6), DOB: (B)(6).
Patient problems: No Code Available; Pain
MAUDE report 8006281 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K101996, K170748. One submission often covers many models, so check the product and lot details in each record.
- Z-0483-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
- Z-0484-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
- Z-0486-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
- Z-0490-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
- Z-0487-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
- Z-0488-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
- Z-0485-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
- Z-0489-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
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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