INHANCE 6201-01-151Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM STEM INSERTER · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295539346), received between Nov 3, 2023 and Sep 23, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Break” (8 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
- Break8
- Material Deformation4
- Naturally Worn3
- Device-Device Incompatibility2
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874724 ↗MalfunctionSep 18, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820075 ↗MalfunctionJul 8, 2026Break
IT WAS REPORTED THAT THE TIP OF THE STEM INSERTER WAS BROKEN, AND THE MEDIUM GLENOID SIZER WAS CRACKED DUE TO GENERAL WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25753520 ↗MalfunctionFeb 2, 2026Break; Material Deformation
IT WAS REPORTED THAT THE PIECES WERE BROKEN AND STRIPPED FROM THE INHANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24234160 ↗MalfunctionFeb 2, 2026Break; Material Deformation
IT WAS REPORTED THAT THE PIECES WERE BROKEN AND STRIPPED FROM THE INHANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24234021 ↗MalfunctionFeb 2, 2026Break; Material Deformation
IT WAS REPORTED THAT THE PIECES WERE BROKEN AND STRIPPED FROM THE INHANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233775 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT INSTRUMENTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435148 ↗MalfunctionAug 11, 2025Break; Break
IT WAS REPORTED THAT THE STEM INSERTER WAS BROKEN AT THE THREAD SIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771336 ↗MalfunctionAug 1, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN WHEN USED IN CONJUNCTION AS A BACK SLAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22690726 ↗MalfunctionJan 7, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE THREADS ON BOTH INSTRUMENTS ARE WARPED AND NEED TO BE REPLACED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21094155 ↗MalfunctionMar 19, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT INSTRUMENTS WERE REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED STATES THAT THREADS APPEARED DAMAGED- WORN. EVENT DID NOT HAPPEN IN OR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18936516 ↗MalfunctionMar 19, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT INSTRUMENTS WERE REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED STATES THAT THREADS APPEARED DAMAGED- WORN. EVENT DID NOT HAPPEN IN OR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18936511 ↗MalfunctionMar 19, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT INSTRUMENTS WERE REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED STATES THAT THREADS APPEARED DAMAGED- WORN. EVENT DID NOT HAPPEN IN OR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18936503 ↗MalfunctionFeb 2, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSERTION HANDLE WOULD NOT ATTACH TO STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18634139 ↗MalfunctionNov 3, 2023Break; Break
IT WAS REPORTED THAT THE THREADED PIECE BROKE OFF. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18064455 ↗
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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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