GLOBAL UNITERecalls & reported problems across all models
Depuy (Ireland) · 91 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 530
- Deaths reported
- 0
- Injuries reported
- 399
- Recalls
- 8
We found 91 models of GLOBAL UNITE by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 530 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2017 and Sep 30, 2026 — classified as 399 injuries, 131 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (36 reports).
8 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
GLOBAL UNITE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 7, 2021Terminated
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Z-0490-2022 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- Dec 7, 2021Terminated
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Z-0489-2022 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- Dec 7, 2021Terminated
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Z-0488-2022 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- Dec 7, 2021Terminated
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Z-0487-2022 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- Dec 7, 2021Terminated
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Z-0486-2022 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- Dec 7, 2021Terminated
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Z-0485-2022 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- Dec 7, 2021Terminated
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Z-0484-2022 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- Dec 7, 2021Terminated
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Z-0483-2022 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported GLOBAL UNITE problems
Device problems
- Adverse Event Without Identified Device or Use Problem310
- Insufficient Device Problem Information36
- Break31
- Device-Device Incompatibility21
- Crack18
- Difficult to Insert17
- Appropriate Device Problem Term/Code Not Available14
- Device Dislodged or Dislocated10
Patient problems
- Pain125
- Unspecified Tissue Injury109
- Unspecified Infection88
- No Code Available71
- No Clinical Signs, Symptoms or Conditions47
- Loss of Range of Motion46
- No Consequences Or Impact To Patient45
- Not Applicable32
GLOBAL UNITE models
91 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GLOBAL UNITE 1100-08-100PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall29 reports
- GLOBAL UNITE 1100-10-100shoulder prosthesis, reverse configuration1 recall29 reports
- GLOBAL UNITE 1100-12-100PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 recall29 reports
- GLOBAL UNITE 1100-14-100shoulder prosthesis, reverse configuration1 recall13 reports
- GLOBAL UNITE 1100-16-100shoulder prosthesis, reverse configuration1 recall5 reports
- GLOBAL UNITE 1100-08-600shoulder prosthesis, reverse configuration1 recall4 reports
- GLOBAL UNITE 1100-06-100PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 recall2 reports
- GLOBAL UNITE 1100-10-600shoulder prosthesis, reverse configuration1 recall1 report
- GLOBAL UNITE 1100-30-000PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED37 reports
- GLOBAL UNITE 2100-70-155SCREWDRIVER34 reports
- GLOBAL UNITE 1100-40-000PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED28 reports
- GLOBAL UNITE 1100-44-600PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED21 reports
- GLOBAL UNITE 1100-44-610PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED21 reports
- GLOBAL UNITE 1100-20-000PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED18 reports
- GLOBAL UNITE 1100-48-610PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED17 reports
- GLOBAL UNITE 1100-50-000PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- GLOBAL UNITE 1100-48-510PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED13 reports
- GLOBAL UNITE 1100-52-610PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED13 reports
- GLOBAL UNITE 1100-52-600PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED11 reports
- GLOBAL UNITE 1100-44-500PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED9 reports
- GLOBAL UNITE 2100-70-150SCREWDRIVER9 reports
- GLOBAL UNITE 1407-20-101PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED9 reports
- GLOBAL UNITE 1100-48-600PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- GLOBAL UNITE 1100-52-620PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- GLOBAL UNITE 2100-50-015TEMPLATE7 reports
- GLOBAL UNITE 1100-30-100PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED6 reports
- GLOBAL UNITE 1100-20-200PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED5 reports
- GLOBAL UNITE 1100-40-500PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED5 reports
- GLOBAL UNITE 1100-52-510PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED5 reports
- GLOBAL UNITE 1100-40-600PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- GLOBAL UNITE 1100-40-610PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED4 reports
- GLOBAL UNITE 1100-44-510PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED4 reports
- GLOBAL UNITE 1100-48-500PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED4 reports
- GLOBAL UNITE 1100-48-520PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED4 reports
- GLOBAL UNITE 1100-48-620PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED4 reports
- GLOBAL UNITE 1100-52-520PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- GLOBAL UNITE 1100-56-610PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- GLOBAL UNITE 1100-60-000PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- GLOBAL UNITE 2100-01-035IMPACTOR4 reports
- GLOBAL UNITE 2100-01-135IMPACTOR4 reports
- GLOBAL UNITE 1100-30-110PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED3 reports
- GLOBAL UNITE 2100-08-100TEMPLATE3 reports
- GLOBAL UNITE 1407-20-103PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED3 reports
- GLOBAL UNITE 1100-12-600PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- GLOBAL UNITE 1100-20-300PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED2 reports
- GLOBAL UNITE 1100-20-400PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 reports
- GLOBAL UNITE 1100-30-010PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 reports
- GLOBAL UNITE 1100-30-120PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- GLOBAL UNITE 1100-40-100PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- GLOBAL UNITE 1100-50-110PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- GLOBAL UNITE 1100-56-510PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- GLOBAL UNITE 1100-56-620PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 reports
- GLOBAL UNITE 2100-06-600TEMPLATE2 reports
- GLOBAL UNITE 2100-08-600TEMPLATE2 reports
- GLOBAL UNITE 2100-10-600TEMPLATE2 reports
- GLOBAL UNITE 2100-12-600TEMPLATE2 reports
- GLOBAL UNITE 2100-50-000TEMPLATE2 reports
- GLOBAL UNITE 2100-09-001TRAY, SURGICAL, INSTRUMENT2 reports
- GLOBAL UNITE 2100-30-015TEMPLATE2 reports
- GLOBAL UNITE 1100-44-530PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- GLOBAL UNITE 1100-20-100PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 report
- GLOBAL UNITE 1100-20-210PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 report
- GLOBAL UNITE 1100-20-310PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 report
- GLOBAL UNITE 1100-20-500PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- GLOBAL UNITE 1100-30-020PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- GLOBAL UNITE 1100-40-010PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- GLOBAL UNITE 1100-40-020PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- GLOBAL UNITE 1100-40-110PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 report
- GLOBAL UNITE 1100-40-120PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- GLOBAL UNITE 1100-44-520PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 report
- GLOBAL UNITE 1100-44-620PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 report
- GLOBAL UNITE 1100-50-100PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 report
- GLOBAL UNITE 1100-52-500PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- GLOBAL UNITE 1100-60-100PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- GLOBAL UNITE 1100-60-120PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- GLOBAL UNITE 2100-06-100TEMPLATE1 report
- GLOBAL UNITE 2100-16-100TEMPLATE1 report
- GLOBAL UNITE 2100-30-000TEMPLATE1 report
- GLOBAL UNITE 2100-30-010TEMPLATE1 report
- GLOBAL UNITE 2100-30-020TEMPLATE1 report
- GLOBAL UNITE 2100-40-000TEMPLATE1 report
- GLOBAL UNITE 2100-40-020TEMPLATE1 report
- GLOBAL UNITE 2100-70-410PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- GLOBAL UNITE 2100-40-015TEMPLATE1 report
- GLOBAL UNITE 2100-60-015TEMPLATE1 report
- GLOBAL UNITE 2100-22-521TEMPLATE1 report
- GLOBAL UNITE 1100-20-010PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- GLOBAL UNITE 1407-20-102shoulder prosthesis, reverse configuration1 report
- GLOBAL UNITE 2100-62-110TEMPLATE1 report
- GLOBAL UNITE 2100-09-013TRAY, SURGICAL, INSTRUMENT1 report
- GLOBAL UNITE 2100-09-014TRAY, SURGICAL, INSTRUMENT1 report
Recent GLOBAL UNITE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had left anatomic total shoulder approximately 10 years ago. Original date of surgery and hospital are unknown. Patient developed rotator cuff arthropathy and was revised to a reverse total shoulder.DOI: Unknown. DOR: (b)(6) 2026.Affected side: Left shoulder.
Patient problems: Unspecified Tissue Injury
MAUDE report 50944837 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had left anatomic total shoulder approximately 10 years ago. Original date of surgery and hospital are unknown. Patient developed rotator cuff arthropathy and was revised to a reverse total shoulder.DOI: Unknown. DOR: (b)(6) 2026.Affected side: Left shoulder.
Patient problems: Unspecified Tissue Injury
MAUDE report 50944799 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had left anatomic total shoulder approximately 10 years ago. Original date of surgery and hospital are unknown. Patient developed rotator cuff arthropathy and was revised to a reverse total shoulder.DOI: Unknown .DOR: (b)(6) 2026.Affected side: Left shoulder.
Patient problems: Unspecified Tissue Injury
MAUDE report 50944743 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50923266 ↗MalfunctionSep 28, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918202 ↗MalfunctionSep 18, 2026No Apparent Adverse Event
It was reported that the impacted product has unknown allegation.During manufacturer's investigation of the returned device it was identified that both guide screw and body's threaded surface stripped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821349 ↗InjurySep 17, 2026Osseointegration Problem
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50810889 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had a mid humeral fracture.DOI: (b)(6) 2026.DOR: (b)(6) 2026. Affected Side: Right Shoulder.
Patient problems: Bone Fracture(s)
MAUDE report 50792462 ↗MalfunctionAug 27, 2026Contamination /Decontamination Problem
Size 98 trial stem of consigned glenoid top tray of delta extend set was found to have bubbles in the 2 strips of plastic/painting around the top of the stem. It is believed to be a contamination concern.Product was removed off the tray and placed out of circulation.The event did not occur during a surgical procedure. Was there any reported patient or user harm? No.Was there a significant delay? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476033 ↗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 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
Patient was revised due to failed rotator cuff, conversion to Delta Xtend. DOI: (b)(6)2018 .DOR: (b)(6)2026.Affected side: Right shoulder.
Patient problems: Unspecified Tissue Injury
MAUDE report 50072428 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient has a failed subscap. Surgeon exchanged head and did a repair.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right shoulder.
Patient problems: Unspecified Tissue Injury
MAUDE report 50061504 ↗InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT CONVERTED PATIENT FROM A TOTAL SHOULDER ARTHROPLASTY TO REVERSE SHOULDER ARTHROPLASTY. THEY REMOVED THE SIZE 10 PROXIMAL BODY, SIZE 44X15 STANDARD HUMORAL HEAD AND A SIZE 44 ANCHOR PEG GLENOID. THE PATIENT HAD A ROTATOR CUFF TEAR WHICH LED TO A CONVERSION OF A TSA TO AN RSA. AFFECTED SIDE-RIGHT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 25664855 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO SUBSCAP FAILURE CONVERTED FROM A TOTAL SHOULDER TO REVERSE, KEEPING THE DISTAL STEM IN PLACE. AFFECTED SIDE: LEFT.
Patient problems: Unspecified Tissue Injury
MAUDE report 25334726 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO SUBSCAP FAILURE CONVERTED FROM A TOTAL SHOULDER TO REVERSE, KEEPING THE DISTAL STEM IN PLACE. AFFECTED SIDE: LEFT.
Patient problems: Unspecified Tissue Injury
MAUDE report 25334635 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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