INHANCE 6500-32-100Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM REVERSE LINER TRIAL Ø32 +0mm · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295547297), received between Mar 29, 2023 and Aug 13, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Break” (16 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
- Break16
- Device-Device Incompatibility5
- Detachment of Device or Device Component1
- Material Deformation1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information2
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240742 ↗MalfunctionApr 9, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT WILL SNAP IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24833073 ↗MalfunctionApr 9, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE PRODUCT WILL NOT SNAP IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24833034 ↗MalfunctionApr 2, 2026Break
IT WAS REPORTED THAT THE STEM INSERTER HANDLE IS CRACKED. LINER TRIALS¿ PEGS ARE SHEARED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24764207 ↗MalfunctionFeb 19, 2026Break
IT WAS REPORTED THAT 32 + OR REVERSE LINER TRIAL HAD A BROKEN TAB ON THE UNDERSIDE OF THE TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24392800 ↗MalfunctionFeb 5, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, THE LOCKING MECHANISM BROKE WILL NOT STAY IN PLACE OF HUMERAL SHELL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273268 ↗MalfunctionOct 21, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE REVERSE LINER TRIAL DID NOT STAY SEATED IN THE REVERSE SHELL TRIAL. THIS WAS NOTICED BEFORE THE PATIENT WAS IN THE ROOM. IT WAS DISCOVERED THAT ONE OF THE PLASTIC LATCHES THAT SECURES THE REVERSE LINER TRIAL TO THE REVERSE SHELL TRIAL WAS BROKEN. THERE WAS NO DELAY TO THE CASE. NO PIECES WERE LEFT IN THE PATIENT. NO HARM TO PATIENT WAS INCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23349116 ↗MalfunctionJul 25, 2025Break; Break
IT WAS REPORTED THAT THE TRIALS WERE CHIPPING. QUALITY ISSUE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22613615 ↗MalfunctionJul 11, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE POLY TRIAL WOULD NOT LOCK AND KEPT SPINNING ON THE BASEPLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22480360 ↗MalfunctionJul 1, 2025Break; Break
IT WAS REPORTED THAT T20 SCREWDRIVER IS STRIPPED AND 32+0R TRIAL IS BROKEN. BOTH ITEMS WERE NOT BROKEN DURING A SURGERY. IT WAS NOTICED WHILE RESETTING THE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378376 ↗MalfunctionJun 10, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WERE BROKEN AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176408 ↗MalfunctionJun 10, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WERE BROKEN AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176377 ↗MalfunctionFeb 25, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT AFTER THE CASE, WHILE PUTTING SETS TOGETHER USER NOTICED THE TAB ON THE 32+0R TRIAL WAS BENT. AFTER USER TOUCHED IT, IT BROKE INTO 2 PIECES. THIS HAPPENED POST OP AND THERE WAS NO NEGATIVE IMPACT TO THE PATIENT NOR WAS SURGERY TIME EXTENDED DUE TO THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21460876 ↗MalfunctionNov 1, 2024Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT SHOULDER REPAIR ON (B)(6) 2024. THE TAB ON 32+0 R POLY TRIAL BROKE MID-CASE. NO DELAY.
Patient problems: Insufficient Information
MAUDE report 20591582 ↗MalfunctionSep 4, 2024Break; Break
THE DEVICE WAS REPORTED FOR AN UNKNOWN REASON/MALFUNCTION. IT DID NOT HAPPEN IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 20133986 ↗MalfunctionOct 10, 2023Break; Break
IT WAS REPORTED THAT ONE OF THE LOCKING TABS HAD BROKEN OFF OF THE TRIAL. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17907066 ↗MalfunctionJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE CASE THE SCRUB TECH NOTICED THAT THE 32 +0 R POLY TRIAL WAS MISSING A LOCKING TAB. SINCE WE WERE UNABLE TO USE THE TRIAL THE DOCTOR TRIALED WITH A DIFFERENT SIZE TO MAKE HIS FINAL IMPLANT DECISION. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT AND SURGERY TIME WAS NOT EXTENDED DUE TO THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17051366 ↗MalfunctionJun 1, 2023Break; Break
IT WAS REPORTED THAT WHEN THE SALES REP WAS PUTTING THE TRAYS TOGETHER AFTER SURGERY AND INSPECTING THE INSTRUMENTS AND NOTICED THE 32 +0 R WAS MISSING A PIECE OF THE TAB THAT SNAPS INTO THE REVERSE SHELL FOR TRIALING. ONLY FOUND 1 PIECE SO IT IS NOT KNOWN IF IT WAS IN 2 PIECES. THIS HAPPENED POST OP SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17040617 ↗MalfunctionMay 30, 2023Break; Break
IT WAS REPORTED THAT ONE OF THE TABS FROM THE REVERSE LINER TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17020287 ↗MalfunctionMar 29, 2023Break; Scratched Material; Break; Scratched Material
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT DID NOT BREAK INTO TWO OR MORE PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16634483 ↗
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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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