PINNACLE 2218-36-456Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 56OD x 36ID + 4 NEUT · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy Pinnacle trial hip liner, a plastic sizing insert surgeons try in place during hip replacement surgery. The 37 reports mostly describe the liner breaking or cracking, sometimes while still on the shelf or during testing, along with scratched surfaces, green residue, and general wear. No deaths or injuries are described. There are no recalls naming this device.
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
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295101376), received between Sep 6, 2017 and Mar 10, 2026 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Break” (12 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
- Break12
- Scratched Material9
- Appropriate Device Problem Term/Code Not Available6
- Contamination /Decontamination Problem5
- Naturally Worn5
- Material Deformation4
- Component Missing1
- Crack1
Patient problems
- No Consequences Or Impact To Patient18
- No Clinical Signs, Symptoms or Conditions16
- No Information3
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE IS REPORTED DUE TO WEAR AND TEAR OVER THE YEARS. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24560186 ↗MalfunctionNov 5, 2025Break; Break
IT WAS REPORTED THAT AT THE TIME OF TESTING THE INSERT IS BROKEN. ALL PARTICLES ARE REMOVED, AND ANOTHER TEST INSERT IS PASSED TO SOLVE AT THE MOMENT AND THIS IS BROKEN THE EDGE. THERE WAS NO AFFECTATION TO THE PATIENT. ALL THE PARTICLES CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477907 ↗MalfunctionMay 29, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL HIP ON AN UNKNOWN DATE, ONE INSTRUMENT BROKE DURING THE CASE. USERS HAD BACK UP SO THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22105033 ↗MalfunctionNov 18, 2024Break; Break
IT WAS REPORTED THAT THE LINER TRIAL WAS BROKEN. ALL PIECES WERE ACCOUNTED FOR. THE TOP BROKE OFF, HOWEVER, IT DID NOT HAPPEN IN SURGERY. NO ADDITIONAL INFORMATION PROVIDED FOR REPORTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20707735 ↗MalfunctionJul 23, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THERE WERE SCRATCHES ON TRIALS. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19806059 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625622 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625541 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625510 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625461 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625412 ↗MalfunctionJan 14, 2022Break; Break
IT WAS REPORTED THAT THE SCREW TIP ON THESE LINERS BROKE OFF DURING SURGERY. ONE PIECE BROKE OFF OF EACH. ALL WERE RETRIEVED AND DISCARDED BY THE OR. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13259096 ↗MalfunctionJul 26, 2021Break; Break
IT WAS REPORTED THAT UPON SELECTING A 56/36 +4 NEUTRAL PINNACLE TRIAL LINER, THE SCRUB TECH NOTICED A CHIP OUT OF THE EDGE OF THE POLY TRIAL. UPON INSPECTION OF THE TRAY, NO FRAGMENTS WERE FOUND. THERE WERE NO TIME DELAYS, NO FRAGMENTS WERE GENERATED NOR FOUND. PATIENT SAFETY WAS NOT COMPROMISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12224209 ↗MalfunctionJun 10, 2021Break; Break
IT WAS REPORTED THAT GRATERS HAVE THE CROSSBACK ATTACHMENT BROKEN OFF. POLY TRIALS HAVE THE SCREWS CRACKED OFF AT THE DOME. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11979705 ↗MalfunctionJun 10, 2021Break; Break
UPON INSPECTION OF LINER TRIAL IN TRAY IT WAS DISCOVERED THERE WERE METAL SHAVINGS EMBEDDED IN THE ARTICULATING SURFACE OF THE LINER TRIAL. IT WAS PULLED FROM THE SET FOR COMPLAINT SUBMISSION. NO PATIENT WAS AFFECTED AND THIS WAS NOT USED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11973603 ↗MalfunctionApr 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED STATED THAT THE RING THAT HOLDS THE SCREW IN (TO THE CUP) PIECE BROKE OR CAME OFF DURING CLEANING. IT WAS GONE. HAVE NO IDEA WHERE OR WHEN IT BROKE OR HOW MANY PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11739900 ↗MalfunctionJan 15, 2021Material Deformation
IT WAS STATED THAT UNRELATED TO THIS SPECIFIC SURGERY, STERILE PROCESSING FOUND THIS LINER TRIAL TO BE MELTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11177793 ↗MalfunctionNov 24, 2020Scratched Material; Scratched Material
THE INSERT HAS A NOTCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10891244 ↗MalfunctionAug 26, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SMALL LOCKING RING ON THE TRIAL LINER WAS BENT DURING SURGERY. NO SURGICAL DELAY NOTED.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10455326 ↗MalfunctionJun 15, 2020Break; Component Missing; Scratched Material; Break; Component Missing; Scratched Material
IT WAS REPORTED THAT THE POLY TRIAL BROKE. RING BROKE SO SCREW WON¿T STAY IN PLACE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10154722 ↗MalfunctionFeb 18, 2020Break; Crack; Break; Crack
IT WAS REPORTED THAT THE POLY LINER HAS CRACKED AT THE SCREW JUNCTION. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9718884 ↗MalfunctionJun 26, 2019Material Discolored; Naturally Worn; Scratched Material; Material Discolored; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE LINERS ARE TOO WORN OUT TO BE USED IN SURGERY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8736446 ↗MalfunctionNov 21, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PINNACLE TRIAL LINERS ARE WORN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8094227 ↗MalfunctionNov 1, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8030700 ↗MalfunctionNov 1, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8030696 ↗MalfunctionNov 1, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8030675 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page