PINNACLE 2218-32-450Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 50OD x 32ID + 4 NEUT · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle acetabular liner trial set is used to try different cup sizes during hip replacement surgery. The 27 reports mostly describe physical wear and damage to the trial parts: cracked or broken liners, scratched and gouged surfaces, metal peeling off the rim, and residue building up on the instruments after cleaning. None of the reports describe a death or an injury, and most note no effect on the patient. There are no recalls of 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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295101024), received between Sep 26, 2017 and Jun 12, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
- Scratched Material9
- Naturally Worn6
- Contamination /Decontamination Problem5
- Material Deformation2
- Detachment of Device or Device Component1
- Disconnection1
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient10
- Insufficient Information2
- No Code Available1
- No Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Break
IT WAS REPORTED THAT PINNACLE ACETABULAR LINER TRIALS HAD BROKEN .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488767 ↗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 19806046 ↗MalfunctionMar 7, 2024Break; Break
IT WAS REPORTED THAT BOTH LINERS WERE BEATEN UP AND HAVE ARDS MISSING. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18855211 ↗MalfunctionNov 28, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TOP OF THE LINER WON'T SCREW INTO THE SHELL DUE TO A PIECE OF METAL STICKING OUT OF THE LINER. A METAL PIECE OF THE LINER GOT RIPPED UP BUT WAS STILL INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18215464 ↗MalfunctionApr 5, 2023Scratched Material; Scratched Material
IT WAS REPORTED THE INSTRUMENTS ARE SCUFFED, SCRATCHED AND DAMAGED. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16682307 ↗MalfunctionDec 21, 2022Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
MDR STAFF REPORTED WORN AND GOUGED PINNACLE 32MM LINER TRIALS. NO PATIENT CONSEQUENCE REPORTED. NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16022963 ↗MalfunctionDec 21, 2022Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
MDR STAFF REPORTED WORN AND GOUGED PINNACLE 32MM LINER TRIALS. NO PATIENT CONSEQUENCE REPORTED. NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16022962 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE MDR REACHED OUT TO ME LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625649 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE MDR REACHED OUT TO ME LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625561 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE MDR REACHED OUT TO ME LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625529 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE MDR REACHED OUT TO ME LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625513 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE MDR REACHED OUT TO ME LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625472 ↗MalfunctionJul 27, 2021Break; Break
IT WAS REPORTED THAT THE METAL LOCKING RING BROKE TRYING TO GET THE TRIAL INTO THE CUP. THE METAL PART CAME OUT WITH THE RING AND ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12228013 ↗MalfunctionMay 21, 2021Break; Break
IT WAS REPORTED AS "BROKEN IN STERILIZATION". NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11864448 ↗MalfunctionJan 28, 2021Detachment of Device or Device Component; Illegible Information; Detachment of Device or Device Component; Illegible Information
IT WAS REPORTED THAT THE POLY LINER TRIALS CAN'T BE READ WITH SIZES ANYMORE OR THE CENTER SCREW HAS COME OFF OF THE 32MM SIZES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11247832 ↗MalfunctionJul 29, 2020Break; Break
IT WAS REPORTED THAT THE LINER TRIAL WAS FOUND TO BE BROKEN IN TRAY. THREADED CAP DISCONNECTED FROM PLASTIC. NOT USED IN THE CASE. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10339798 ↗MalfunctionJun 21, 2019Break; Unintended Movement; Break; Unintended Movement
IT WAS REPORTED THAT THE TRIAL LINER WAS INSERTED INTO OLD CUP AND SOMEHOW THE C-RING AND SCREW POST CAME LOOSE. THE LINER , C-RING,AND SCREW POST WERE REMOVED FROM THE JOINT. THERE WAS ABOUT 1 MINUTE DELAY IN THE CASE. THE PIECES WERE SENT DOWN TO SPD IN A DISPOSABLE CUP WITH LID. THE TECHS IN SPD THROUGH AWAY. THEY DIDN'T KNOW WHERE THEY WERE SUPPOSED TO GO.
Patient problems: Not Applicable
MAUDE report 8723920 ↗MalfunctionFeb 15, 2019Break; Material Deformation; Scratched Material; Break; Material Deformation; Scratched Material
IT WAS REPORTED THAT UPON INSPECTION OF INSTRUMENTS IT WAS NOTICED THAT SOME WERE SCRATCHED AND WORN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8344106 ↗MalfunctionNov 5, 2018Break; Break
IT WAS REPORTED THAT DURING TRAILING THE METAL SCREW PART OF 2 LINER TRIALS BROKE. ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8039765 ↗MalfunctionOct 31, 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 8023968 ↗MalfunctionOct 31, 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 8023957 ↗MalfunctionOct 31, 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 8023950 ↗MalfunctionOct 31, 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 8023924 ↗MalfunctionSep 13, 2018Disconnection; Disconnection
IT WAS REPORTED THAT DURING TRIALING THE CLIP THAT HOLDS THE PINNACLE TRIAL LINER TOGETHER DISASSOCIATED. ALL 3 PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7872599 ↗MalfunctionMar 12, 2018Break; Break
IT WAS REPORTED THAT TABS ON LINER TRIAL ARE BROKEN OFF AND DAMAGED BEYOND REPAIR. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7330269 ↗
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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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