INHANCE 6500-36-000Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM REVERSE LINER TRIAL Ø36 +0mm · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy INHANCE reverse shoulder liner trial is used to check fit during shoulder surgery. Reports mostly describe broken locking tabs or clips, preventing the liner from staying attached to the shell, along with fit incompatibility. There are 24 reports, with no deaths and no injuries; no recalls name this device. Reports fell from 13 in the previous 12 months to 3 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295547327), received between Mar 29, 2023 and Jan 23, 2026 — classified as 24 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 Incompatibility6
- Crack1
- Material Deformation1
- Naturally Worn1
- Scratched Material1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information4
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE 36+0 LINER TRIAL HAS A BROKEN CLIP. WON'T STAY ATTACHED TO SHELL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24172928 ↗MalfunctionJan 9, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 36 + 0 REVERSE LINER TRIAL WILL NOT SNAP INTO THE REVERSE TRIAL SHELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24020884 ↗MalfunctionDec 17, 2025Break; Break
IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY, THE SURGEON NOTED THAT BOTH THE 36+0 AND 36+4 REVERSE LINER TRIALS WERE BROKEN. EACH OF THEM HAD A BROKEN LOCKING TAB SUCH THAT THEY DIDN'T STAY IN THE REVERSE SHELL TRIAL. THERE WERE NO BROKEN PIECES AS THE INSTRUMENT APPEARS TO HAVE BEEN BROKEN BEFORE SURGERY BEGAN. THERE WAS NO DELAY OR COMPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826730 ↗MalfunctionOct 20, 2025Break; Break
IT WAS REPORTED THAT WHEN TRIALING THE 36+0 LINER TRIAL, DR. NOTICED THE TAB THAT LOCKS IT INTO THE SHELL TRIAL WAS BROKEN PREVENTING THE TRIAL FROM STAYING TOGETHER. HE WAS STILL ABLE TO PERFORM A TRIAL REDUCTION, SO NO DELAYS OR ADVERSE EVENTS TOOK PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23335387 ↗MalfunctionSep 19, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT DURING TRAY ASSEMBLY THAT THE LINER TRIAL WAS NOT LOCKING INTO SHELL TRIAL (WAS VERY LOOSE) AND THAT THE MEDIUM STD STEM TRIAL THREADS ARE DAMAGED AND WILL NOT ENGAGE INSERTION HANDLE PROPERLY. NO TIME DELAY NO HARM TO PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23094486 ↗MalfunctionAug 29, 2025Break; Break
IT WAS REPORTED THAT THE LINER TRIAL LOCKING TAB SNAPPED OFF DURING TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22924086 ↗MalfunctionAug 29, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRIAL LINER HAS A BROKEN TAB AND DOESN'T LOCK INTO SHELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922524 ↗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 22613760 ↗MalfunctionJun 19, 2025Break; Break
IT WAS REPORTED THAT THE TAB WAS BROKEN ON TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22293456 ↗MalfunctionMay 1, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE POLY TRIAL DOES NOT LOCK INTO THE SHELL. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21943881 ↗MalfunctionApr 22, 2025Break; Break
IT WAS REPORTED THAT WHILE GOING THROUGH INSTRUMENTS TO TURN THEM OVER FOR CASES, IT WAS NOTICED THAT THESE INSTRUMENTS WERE ALL BROKEN AND NEEDED TO BE REPLACED. THERE WERE NO DELAYS OR ADVERSE EVENTS THAT TOOK PLACE FOR ANY OF THE DOCTOR'S CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21881413 ↗MalfunctionMar 24, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
ADDITIONAL EVENT INFORMATION RECEIVED: THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21678905 ↗MalfunctionFeb 19, 2025Break; Break
IT WAS REPORTED THAT WHEN REMOVING THE TRIAL POLY, THE LOCKING TAB BROKE OFF. ALL PARTS WERE RETRIEVED AND NO SURGICAL DELAYS TOOK PLACE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21414593 ↗MalfunctionJan 15, 2025Break; Material Deformation; Scratched Material; Break; Material Deformation; Scratched Material
IT WAS REPORTED THAT RETENTION TABS ON REVERSE LINER TRIALS ARE COMPROMISED AND NO LONGER FUNCTIONAL DUE TO GOUGING, SHEARED OFF, OR BENT OUT OF PROPER SHAPE. EVENT OCCURRED DURING POST-OP RESET AND INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21159771 ↗MalfunctionDec 31, 2024Break; Break
IT WAS REPORTED DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2024, THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21047954 ↗MalfunctionDec 27, 2024Break; Break
IT WAS REPORTED THAT ONE OF THE LOCKING TABS ON THE LINER TRIAL BROKE OFF WHILE REMOVING IT FROM THE SHELL DURING THE TRIALING PROCESS. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21025986 ↗MalfunctionJun 10, 2024Break; Break
IT WAS REPORTED THAT THE PLASTIC POLY TRIAL LOCKING MECHANISM BROKE OFF. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19498622 ↗MalfunctionApr 19, 2024Break; Crack; Naturally Worn; Break; Crack; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN OR DAMAGED. PARTS WERE EITHER CRACKED OR COMPLETELY BROKEN DUE TO EXCESSIVE USE AND WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19142754 ↗MalfunctionMar 12, 2024Break; Break
DURING CASE SETUP TRIAL WAS NOTED TO HAVE DAMAGE TO THE RETENTION TAB, PREVENTING IT FROM BEING USABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18891758 ↗MalfunctionDec 20, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18367519 ↗MalfunctionJul 28, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: THE LOCKING TAB BROKE. IT BROKE INTO 2 PIECES BUT ONLY 1 PIECE WAS THERE AS SPD TECH ONLY GAVE PROVIDED THE TRIAL, AND NOT THE LOCKING TAB THAT IS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17415171 ↗MalfunctionMay 19, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL HAD A BROKEN RETAINING CLIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16967310 ↗MalfunctionApr 5, 2023Break; Break
IT WAS REPORTED THAT BY THE SPD TECH CLEANING THE INSTRUMENTS AFTER THE PROCEDURE THAT DURING DECONTAMINATION ONE OF THE LOCKING TABS ON A POLY TRIAL FELL OFF AND WENT DOWN THE DRAIN OF THE SINK. TRIAL WAS RETRIEVED AND FILLED OUT THIS MDR. EVENT OCCURRED POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16681976 ↗MalfunctionMar 29, 2023Break; Break
IT WAS REPORTED THAT THE SCREW DRIVER STRIPPED AND TAB ON POLY BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16637105 ↗
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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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