INHANCE 6500-36-104Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM REVERSE LINER TRIAL RETENTIVE Ø36 +4mm · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295547372), received between Jul 28, 2025 and Jan 23, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Break
IT WAS REPORTED THAT TWO OF THE REVERSE POLY TRIALS HAD BROKEN CLIPS. IT WAS REPORTED THAT THE DEVICES WOULD BE REMOVED FROM THE TRAY UNTIL THEY WERE REPLACED. THE EVENT OCCURRED POST OP SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT NOR WAS SURGERY TIME EXTENDED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24172946 ↗MalfunctionJan 23, 2026Break
IT WAS REPORTED THAT TWO OF THE REVERSE POLY TRIALS HAD BROKEN CLIPS. IT WAS REPORTED THAT THE DEVICES WOULD BE REMOVED FROM THE TRAY UNTIL THEY WERE REPLACED. THE EVENT OCCURRED POST OP SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT NOR WAS SURGERY TIME EXTENDED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24172945 ↗MalfunctionNov 7, 2025Break; Break
IT WAS REPORTED THAT THE ¿BROKEN TRIAL IN INHANCE TRIAL INSTRUMENT WAS THE 36 +4 RETENTIVE.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498675 ↗MalfunctionJul 31, 2025Break; Break
IT WAS REPORTED THAT THE 36+4R POLY TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22680332 ↗MalfunctionJul 28, 2025Break; Break
IT WAS REPORTED THAT THE TRIALS WERE CHIPPING. QUALITY ISSUE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22632333 ↗
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