GLOBAL UNITE 2100-08-100Recalls & reported problems
Depuy (Ireland) · GLOBAL UNITE STANDARD STEM TRIAL, SIZE 8 · Class 1
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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295085256), received between Aug 16, 2017 and Aug 27, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionFeb 8, 2024Break; Break
IT WAS REPORTED THAT THE PAINT SEEN CHIPPED IN A FEW PLACES ON TRIAL. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: HOSPITAL. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18668777 ↗MalfunctionAug 16, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE COLOUR BANDING HAS POP MARKS.
Patient problems: No Information
MAUDE report 6796938 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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.
How reports and recalls are matched · Editorial policy · Report an error on this page