INHANCE 6200-46-185Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 46mm X 18.5mm · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295539223), received between Jan 10, 2023 and Sep 14, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 reports).
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
- Break6
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760575 ↗MalfunctionAug 26, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50451927 ↗MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT THE TRIAL WAS BROKEN. IT WAS REPORTED THAT THE PATIENT WAS NOT AFFECTED. THERE WAS NO DELAY OF CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25159355 ↗MalfunctionApr 16, 2024Break; Break
IT WAS REPORTED THAT THE SMALL PLASTIC TABS ON THE BACK OF HUMERAL HEAD TRIALS 46X16 & 46X18.5 BROKE OFF. PATIENT WAS NOT HARMED AND THERE WAS NO SURGICAL DELAY IN CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19121275 ↗MalfunctionMar 11, 2024Break; Break
IT WAS REPORTED THAT THE TABS BROKE OFF OF THE HUMERAL HEAD TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18874221 ↗MalfunctionMar 16, 2023Break; Break
IT WAS REPORTED THAT THE INSIDE OF TRIAL BROKE. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16555235 ↗MalfunctionJan 10, 2023Break; Break
IT WAS REPORTED THAT HEAD TRIALS BROKE WHILE DISENGAGING/ENGAGING OFFSET ADAPTER. THERE WAS 10 MINUTES SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 16132388 ↗
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- 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.
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