INHANCE 6500-32-104Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM REVERSE LINER TRIAL RETENTIVE Ø32 +4mm · Class 1
All models of INHANCE (202)
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 10603295547310), received between Nov 21, 2024 and Jul 10, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Break; Break
IT WAS REPORTED THAT WHEN PICKING UP TRAYS FROM CASES THAT WERE DONE THE PREVIOUS DAY, STAFF NOTICED THE TWO TRIAL INSTRUMENTS WERE BROKEN. THE PARTS NEEDED TO BE REPLACED TO GET THE SET BACK IN WORKING ORDER. NO DELAYS TOOK PLACE IN THE CASES. ALL PARTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22473171 ↗MalfunctionApr 22, 2025Break; Break
IT WAS REPORTED THAT WHILE GOING THROUGH INSTRUMENTS TO TURN THEM OVER FOR CASES, IT WAS NOTICED THAT THESE INSTRUMENTS WERE ALL BROKEN AND NEEDED TO BE REPLACED. THERE WERE NO DELAYS OR ADVERSE EVENTS THAT TOOK PLACE FOR ANY OF THE DOCTOR'S CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21881412 ↗MalfunctionNov 21, 2024Break; Break
IT WAS REPORTED THAT THE TRIAL BROKE WHEN REMOVING.
Patient problems: Insufficient Information
MAUDE report 20748067 ↗
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