INHANCE 6500-40-004Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM REVERSE LINER TRIAL Ø40 +4mm · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295547402), received between Aug 1, 2025 and Jun 18, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Device-Device Incompatibility2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2026Crack
IT WAS REPORTED THE TABS BROKE OFF OF TWO POLY TRIALS IN THE INHANCE TRAY. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25546543 ↗MalfunctionApr 6, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE CHIPPED UPON INSPECTION IN WAREHOUSE. THIS EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793053 ↗MalfunctionSep 11, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE TABS ON TRIAL LINERS WERE BROKEN AND THEY WOULD NOT STAY LOCKED IN TO SHELL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23026543 ↗MalfunctionAug 1, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE POLY TRIAL WOULD NOT SNAP INTO THE SHELL. IT DID NOT HAPPEN DURING THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22688686 ↗
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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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