INHANCE 6200-40-157Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 40mm X 15.75mm · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295539162), received between Jan 17, 2023 and Jan 29, 2026 — classified as 4 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
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2026Break
IT WAS REPORTED THAT HEAD TRIAL WAS BROKEN WHEN CASE STARTED. SCRUB WENT TO PUT ADAPTER INSIDE OF IT, AND IT WOULD NOT MATE. IT DID ADD TIME TO CASES. LOOKS LIKE A RING INSIDE THE HEAD TRIAL CAME LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209360 ↗MalfunctionJan 23, 2026Break
IT WAS REPORTED THAT REVERSED TOTAL SHOULDER REVISION DUE GLENOSPHERE AND LINER IMPINGEMENT. PATIENT AS CONVERTED TO HEMI ARTHOPLASTY. DURING THE PROCEDURE THE HEAD TRIAL WAS DAMAGE WHERE THE ADAPTOR FOR HEAD AND TRIAL MEET. THE ATTACHMENT TABS BROKE OFF. THERE WAS NO HARM TO PATIENT AND NO SURGICAL DELAY. DOE: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159703 ↗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 22395270 ↗MalfunctionJan 17, 2023Break; Break
IT WAS REPORTED THAT AFTER THE CASE THE SPD TECH NOTIFIED THAT SOME WHITE PLASTIC TABS HAD FALLEN COME OFF OF A HUMERAL HEAD TRIAL 40X15.75 AFTER BEING WASHED. 5 TABS HAD BROKEN OFF. THERE WAS NO DELAY TO SURGERY TIME OR NEGATIVE IMPACT TO THE PATIENT SINCE THIS HAPPENED POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16183570 ↗
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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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