INHANCE 6200-40-137Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 40mm X 13.75mm · 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 10603295539155), received between Jan 11, 2023 and Oct 17, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Device-Device Incompatibility1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL HEAD AND ADAPTER BROKE WHILE REMOVING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23323696 ↗MalfunctionJul 3, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PLASTIC WOULD NOT SNAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22395267 ↗MalfunctionJun 30, 2025Break; Break
IT WAS REPORTED THAT THE TRIALS HAVE BROKEN PARTS ON THE BOTTOM, AND THE GLENOSPHERE TIP WAS INTERNALLY STRIPPED. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22357403 ↗MalfunctionFeb 10, 2025Break; Break
IT WAS REPORTED THAT THE HEAD TRIAL BROKE (SMALL PIECE WHERE ATTACHES TO TRIAL TAPER). ALL BROKEN PIECES RETRIEVED. THERE WERE NO SURGICAL DELAY AND THE PROCEDURE DID NOT AFFECT THE CASE IN ANYWAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21343654 ↗MalfunctionJan 11, 2023Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT SEVERAL TRIAL BROKEN INSTRUMENTS. WEAR AND TEAR OF PRODUCT. TRIAL GLENOID CHIPPED WHILE IMPACTING. TRIAL HEADS SNAPPED WHILE ENGAGING/DISENGAGING OFFSET TAPER ADAPTER. HEAD IMPACTOR BROKE WHILE IMPLANTING FINAL IMPLANTS. THERE WAS 10 MINUTES SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 16137023 ↗
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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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