INHANCE 6200-46-160Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 46mm X 16mm · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295539216), received between Nov 8, 2022 and Sep 14, 2026 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Break” (21 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
- Break21
- Device-Device Incompatibility2
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information7
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760619 ↗MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50523657 ↗MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT THE 5 REVERSE HUMERAL TRIALS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24086973 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT 5 BROKEN REVERSE HUMERAL TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24066565 ↗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 22088739 ↗MalfunctionMay 21, 2025Break; Break
IT WAS REPORTED THAT LOCKING PIECE INSIDE HEAD TRIAL BROKE.
Patient problems: Insufficient Information
MAUDE report 22062633 ↗MalfunctionApr 21, 2025Break; Break
IT WAS REPORTED THAT THE TABS ON THE ADAPTER SIDE OF THE HUMERAL HEAD TRIAL BROKE OFF WHEN TRYING TO INSERT THE TRIAL ADAPTER. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21871951 ↗MalfunctionMar 4, 2025Break; Break
IT WAS REPORTED THAT PLASTIC TABS WERE BROKEN ON A HUMERAL HEAD TRIAL.
Patient problems: Insufficient Information
MAUDE report 21517878 ↗MalfunctionSep 27, 2024Break; Break
IT WAS REPORTED THAT THE TRIED USING TRIAL HEAD, REALIZED THE FEET WERE BROKEN OFF. HAD TO OPEN BACKUP SET.
Patient problems: Insufficient Information
MAUDE report 20320780 ↗MalfunctionAug 9, 2024Break; Break
IT WAS REPORTED THAT THE PLASTIC TABS ON THE UNDERSIDE OF THE HUMERAL HEADS WERE BROKEN. THIS MADE IT DIFFICULT TO GET THE HUMERAL PIN GUIDE TO ENGAGE INTO THE HEAD TRIAL FOR THE CASE. NO DELAYS OR ADVERSE EVENTS TOOK PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950572 ↗MalfunctionApr 30, 2024Break; Break
IT WAS REPORTED THAT HUMERAL HEAD TRIAL TINES BROKE WHILE TRIALING.
Patient problems: Insufficient Information
MAUDE report 19215937 ↗MalfunctionApr 16, 2024Break; Break
IT WAS REPORTED THAT THE SMALL PLASTIC TABS ON THE BACK OF HUMERAL HEAD TRIALS 46X16 & 46X18.5 BROKE OFF. PATIENT WAS NOT HARMED AND THERE WAS NO SURGICAL DELAY IN CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19121270 ↗MalfunctionMar 12, 2024Break; Break
DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY THE ALLEGED DEFICIENCY OF THE INSTRUMENTS. WERE THEY BENT, STRIPPED, CROSS-THREADED, ETC.? YES, IT BROKE INTO FOUR PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18891601 ↗MalfunctionMar 11, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: A. WHICH PART OF THE INSTRUMENT BROKE? THE PLASTIC CENTER TABS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18874174 ↗MalfunctionSep 29, 2023Break; Break
IT WAS REPORTED THAT THE SCRUB TECH BROKE TRIAL ON BACK TABLE, WHEN EXTRACTING TRIAL COMPONENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17844744 ↗MalfunctionMar 30, 2023Break; Break
IT WAS REPORTED, THAT THE HEAD TRIAL IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16643772 ↗MalfunctionMar 3, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE HUMERAL PIN GUIDE WAS GOING TO BE USED FOR PLACEMENT OF THE HUMERAL PIN AND THE PIN GUIDE WOULD NOT STAY IN THE 46X16 HEAD TRIAL. THAT WAS WHEN THE SURGEON NOTICED THAT THE TABS IN THE HEAD TRIAL WERE BROKEN. WHEN LOOKING TO GRAB A DIFFERENT HEAD TRIAL, IT WAS NOTICED THAT THE TABS WERE BROKEN ON THE 44X15.25 HEAD TRIAL AS WELL. ALSO, WHEN PREPPING THE HUMERAL SIDE FOR A SHORT STEM, ONE OF THE PINS FROM THE HUMERAL PIN PUNCH BROKE OFF. THERE WAS A SURGICAL DELAY OF 5 MINUTES.
Patient problems: Insufficient Information
MAUDE report 16478156 ↗MalfunctionJan 10, 2023Break; Break
IT WAS REPORTED THAT HEAD TRIALS BROKE WHILE DISENGAGING/ENGAGING OFFSET ADAPTER. THERE WAS 10 MINUTES SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 16132371 ↗MalfunctionDec 9, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN TRIALING THE HUMERAL HEAD, THE SURGEON NOTICED THAT SOME OF THE PLASTIC TABS ON THE INSIDE OF THE HEAD TRIAL HAD BROKEN. MAKING IT DIFFICULT FOR THE ADAPTER TRIAL TO STAY ENGAGED IN THE HEAD TRIAL. THE SURGEON ASKED TO REPLACE THE 46X16 HEAD TRIAL. ALL PLASTIC BROKEN PARTS WERE FOUND AND REMOVED FROM THE FIELD. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15949869 ↗MalfunctionDec 6, 2022Break; Unintended Movement; Break; Unintended Movement
IT WAS REPORTED THAT MULTIPLE TABS FROM INHANCE HEAD TRIAL HAVE BROKEN LOOSE. TRIAL NO LONGER USABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15926991 ↗MalfunctionNov 8, 2022Break; Break
IT WAS REPORTED THAT THE LOCKING TABS IN THE HUMORAL HEAD TRIAL HAVE BROKEN. SEVERAL OF THESE LOCKING TAB HAVE SNAPPED OFF. THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15751437 ↗
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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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