INHANCE 6200-42-145Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 42mm X 14.5mm · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295539179), received between Feb 16, 2022 and Jan 20, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Crack1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026Break
IT WAS REPORTED THAT THE LOCKING TABS WERE BROKEN FROM SCRUB TURNING ADAPTOR WRONG WAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24116631 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT THE HUMERAL HEAD TRIAL DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23850065 ↗MalfunctionDec 2, 2025Crack; Crack
IT WAS REPORTED THAT THE TAB CRACKED/BROKEN OFF HUMERAL HEAD TRIAL FOR INHANCE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693244 ↗MalfunctionMay 27, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTATION BROKE FROM THE SET. IT WAS NOTICED BEFORE THE CASE. A NEW SET WAS BROUGHT TO NOT DELAY THE CASE. THERE WAS NO DELAY. NO BROKEN PIECES LEFT ON FIELD OR PATIENT. NO SURGEON COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22088757 ↗MalfunctionFeb 19, 2024Break; Break
IT WAS REPORTED THAT THE TAB BROKE. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18730776 ↗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 16137021 ↗MalfunctionFeb 16, 2022Break; Break
IT WAS REPORTED THAT ON INSPECTION 3 BROKEN TABS ON THE HEAD TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13543133 ↗
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