PINNACLE 2218-32-050Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 50OD x 32ID NEUTRAL · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle trial liner is a neutral plastic trial insert used to size hip implants during surgery. The 43 reports mostly describe liners that broke, scratched, dented or warped during handling or reprocessing, sometimes not fitting back into the shell and delaying surgery; one injury was reported and no deaths. 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
- 44
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295100713), received between Aug 4, 2017 and Sep 14, 2026 — classified as 1 injury, 43 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
- Scratched Material10
- Material Deformation8
- Contamination /Decontamination Problem6
- Device-Device Incompatibility5
- Detachment of Device or Device Component3
- Appropriate Device Problem Term/Code Not Available2
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Consequences Or Impact To Patient10
- No Information3
- Insufficient Information2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Break
It was reported that the Pinnacle Liner Trials were broken. There was no patient or user harm reported. There was no significant delay reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753474 ↗MalfunctionJun 9, 2026Break
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE, THE PINNACLE ACETABULAR LINER TRIALS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25449440 ↗MalfunctionApr 29, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THESE TRIAL LINERS WERE CROSS THREADED AND NO LONGER FIT INTO THE SHELL. NO PATIENT HARM. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25026774 ↗MalfunctionApr 29, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THESE TRIAL LINERS WERE CROSS THREADED AND NO LONGER FIT INTO THE SHELL. NO PATIENT HARM. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25026770 ↗MalfunctionApr 29, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THESE TRIAL LINERS WERE CROSS THREADED AND NO LONGER FIT INTO THE SHELL. NO PATIENT HARM. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25026749 ↗MalfunctionApr 22, 2026Device-Device Incompatibility; Material Deformation
MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THESE TRIAL LINERS WERE CROSS THREADED AND NO LONGER FIT INTO THE SHELL. PIN TRL LNR NEUT 48ODX32ID (221832048) : NOT APPLICABLE, PIN TRL LNR NEUT 50ODX32ID (221832050) : NOT APPLICABLE, PIN TRL LNR NEUT 520DX36ID (221836052) : NOT APPLICABLE, PIN TRL LNR NEUT 540DX36ID (221836054) : NOT APPLICABLE, WAS THERE ANY REPORTED PATIENT OR USER HARM? NO, WAS THERE A SIGNIFICANT DELAY? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954817 ↗MalfunctionFeb 20, 2026Material Deformation; Scratched Material
IT WAS REPORTED THAT TRIAL DEVICE WAS DENTED AND SCRATCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24405161 ↗MalfunctionFeb 18, 2026Scratched Material
IT WAS REPORTED THAT THE LINER TRIAL SIZE 50N WAS SCRATCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378055 ↗MalfunctionJul 14, 2025Break; Break
IT WAS REPORTED DEVICES WERE BROKEN THROUGH GENERAL USAGE. SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22493369 ↗MalfunctionJun 18, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED SEVERAL PINNACLE TRIAL LINERS HAVE BEEN SCRATCHED DUE TO WEAR AND TEAR, AS WELL AS NO LONGER THREADING PROPERLY INTO THE TRIAL SHELL. NO PATIENT CONSEQUENCES
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22285123 ↗MalfunctionFeb 25, 2025Crack; Crack
IT WAS REPORTED THAT TRIAL LINERS WERE WORN/CRACKED. SCREWS ARE WORN AND CRACKS IN THE PLASTIC. THIS EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21462900 ↗MalfunctionAug 9, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE LINER TRIAL IS SCRATCHED.
Patient problems: Insufficient Information
MAUDE report 19948289 ↗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 19805923 ↗MalfunctionMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CLIP THAT HOLDS IN THE THREADED PIECE OF THE POLY TRIAL CAME OFF. IT WAS NOT ABLE TO SCREW IN THE TRIAL TO THE CUP. THIS DID NOT AFFECT THE SURGERY IN ANY WAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870671 ↗MalfunctionFeb 27, 2024Break; Break
IT WAS REPORTED THAT LINER TRIAL SCREW BROKE, NO PATIENT ISSUES. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793329 ↗MalfunctionAug 22, 2023Break; Break
IT WAS REPORTED THAT LINER TRIALS (48,50MM) WERE BROKEN. ATTUNE ARTICULAR SURFACE TRIALS (5,6 FB) WERE ALSO BROKEN. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17595641 ↗MalfunctionApr 3, 2023Scratched Material; Scratched Material
ADDITIONAL INFORMATION RECEIVED. A. IT WAS MENTIONED IN DER, THAT DEPUY SYNTHES INSTRUMENTATION BROKE, DURING SURGERY, CAN YOU PLEASE CONFIRM? WERE THERE ANY PIECES BROKEN OFF FROM THE INSTRUMENT? DID IT BREAK INTO 2 OR MORE PIECES? B. THE DER IS MARKED "YES", FOR PIECES BEING RETRIEVED FROM THE PATIENT. PLEASE VERIFY, IF THIS WAS MARKED BY MISTAKE OR IF THE INSTRUMENT BROKE INTO 2 OR MORE PIECES. AND WAS LEFT IN THE PATIENT? A. I ACCIDENTALLY, HAD IT MARKED AS DURING SURGERY. BUT THIS DID NOT HAPPEN THEN, BUT RATHER, DURING STERILIZATION. B. THIS WAS MARKED BY MISTAKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16663918 ↗MalfunctionMar 1, 2023Break; Break
IT WAS REPORTED THAT THE LINER TRIAL BROKE, APEX SCREW BROKE OFF THE LINER TRAY. ALL PIECES RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16458528 ↗MalfunctionOct 18, 2022Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component
LINER TRIAL SCREWS DISENGAGED WHEN ATTEMPTING TO SCREW INTO THE ACETABULAR SHELL. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15624784 ↗MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15617014 ↗MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT MDR REACHED OUT LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15615951 ↗MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
CLEANING PROTOCOL RECEIVED FROM THE HOSPITAL: THE CUSTOMER STATED THAT: WHEN THE TRAYS ARRIVE IN DECONTAMINATION THEY ARE SOAKED IN THE ENZYMATIC SOLUTION FOR 5 MINUTES AND ARE THEN MANUALLY CLEANED BY AN MDRT. AFTER THAT, THEY GO INTO OUR ULTRASONICS FOR 10 MINUTES. WHEN THEY COME OUT OF THE ULTRASONIC, WE PUT THEM THROUGH OUR AUTOMATED INSTRUMENT WASHERS. ONCE THE TRAYS COME OUT OF THE WASHERS ON OUR "CLEAN" SIDE, WE DRY THE CONTENTS, CHECK THEM FOR SOIL, ASSEMBLE AS NECESSARY AND THEN THEY GO INTO OUR AUTOCLAVE ON THE STANDARD CYCLE OF 4MIN AT 270 DEGREES F. THE ENZYMATIC SOLUTION WE USE IN THE SOAK AND MANUAL CLEAN STEP IS A STERIS PRODUCT CALLED VALSURE ENZYMATIC CLEANER. WE MIX IT AT 1/2OZ VALSURE TO 1 GALLON OF WATER. THE OTHER PRODUCTS WE USE ARE AUTOMATED WASHERS. THEY ARE ALL STERIS PRODUCTS. WE USE PROLYSTICA ENZYMATIC CLEANER, PROLYSTICA NEUTRAL DETERGENT AND PROLYSTICA LUBRICANT NON-SILICONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15615847 ↗MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT MDR REACHED OUT LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15615811 ↗MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT MDR REACHED OUT LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15615728 ↗MalfunctionAug 5, 2022Material Deformation; Material Deformation
DURING STERILIZATION THE LINERS WERE MELTED. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15174628 ↗
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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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