INHANCE 6200-44-172Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 44mm X 17.25mm · 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 10603295539209), received between Aug 11, 2023 and Dec 5, 2025 — 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 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.
MalfunctionDec 5, 2025Break; Break
IT WAS REPORTED THAT THE PEGS INSIDE THE HUMERAL HEAD TRIAL SHEARED OFF. DOI- UNKNOWN. DOR-UNKNOWN. AFFECTED SIDE- UNKNOWN SHOULDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23732439 ↗MalfunctionJul 8, 2025Break; Break
IT WAS REPORTED THAT STAFF NOTICED THAT THE TEETH ON THE BOTTOM OF THE 44 HEAD TRIALS WERE BROKEN OFF. NO PIECES WERE IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22441719 ↗MalfunctionJul 11, 2024Break; Break
IT WAS REPORTED THAT THE TABS ON THE BACK OF TRIAL ARE BROKEN.
Patient problems: Insufficient Information
MAUDE report 19720159 ↗MalfunctionMar 13, 2024Break; Break
IT WAS REPORTED THAT THE PLASTIC TINES INSIDE THE HEAD TRIAL BROKE OFF WHILE REMOVING THE HUMERAL HEAD ADAPTER FROM THESE 2 TRIAL HEADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18894710 ↗MalfunctionAug 11, 2023Break; Break
IT WAS REPORTED THAT THE HUMERAL HEAD TRIAL PIECES BROKE OFF WHILE TRYING TO ATTACH THE OFFSET ADAPTER BEFORE THE SURGERY BEGAN. SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17510293 ↗
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- 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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