PINNACLE 2218-36-058Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 58OD x 36ID NEUT · Class 1
All models of PINNACLE (198)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle trial liner is a plastic insert used to try hip implant sizes during surgery. Most of the 64 reports describe the liner breaking, cracking, chipping, or wearing down, and no longer threading properly into the trial shell; in a few cases a piece broke off during surgery and had to be picked out of the wound. There are 64 reports, no deaths, and 1 injury. No recalls name this device, and reports have dropped sharply in the past 12 months, from 5 to 1.
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
- 65
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10603295101208), received between Aug 11, 2017 and Sep 14, 2026 — classified as 1 injury, 64 malfunctions.
The most frequently reported specific device problem is “Break” (38 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break38
- Naturally Worn15
- Crack13
- Material Discolored10
- Scratched Material7
- Contamination /Decontamination Problem6
- Detachment of Device or Device Component4
- Material Deformation3
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Consequences Or Impact To Patient22
- Not Applicable2
- No Code Available1
- No Information1
Recent adverse event reports
The 25 most recent of 65 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 50753472 ↗MalfunctionApr 15, 2026Break
IT WAS REPORTED THAT THE METAL PIECE BROKE OFF THE INSERT TRIAL. NO TIME WAS ADDED TO THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887300 ↗MalfunctionSep 18, 2025Break; Break
IT WAS REPORTED THAT THE LINER TRIALS AND NECK SEGMENT ARE BROKEN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085944 ↗MalfunctionJul 8, 2025Break; Break
IT WAS REPORTED DURING THR SURGERY, THE SURGEON USED AN OSTEOTOME TO REMOVE AN ACETABULAR OSTEOPHYTE WHILE THE DEFINITIVE CUP AND TRIAL LINER WERE IN SITU. IN THIS PROCESS, A PIECE OF THE TRIAL LINER WAS CHIPPED OFF. THE PIECE WAS EASILY REMOVED FROM THE WOUND AND THE OPERATION SITE WITH NO MEDICAL INTERVENTION. THE REST OF THE WOUND WAS CHECKED FOR ANY DEBRIS, SURGEON AND ASSISTANT CONFIRMED THAT NO FURTHER DEBRIS WAS PRESENT AND RESUMED SURGERY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22440200 ↗MalfunctionJun 18, 2025Material Deformation; Scratched Material; Material Deformation; 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 (B)(4) ARE RELATED TO EACH OTHER. THIS PC HAS BEEN CREATED TO CAPTURE ADDITIONAL IP'S FROM (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22286164 ↗MalfunctionJun 17, 2025Material Deformation; Scratched Material; Material Deformation; Scratched Material
IT WAS REPORTED THE PINNACLE TRIAL LINERS HAVE BEEN SCRATCHED DUE TO WEAR AND TEAR; THEY ALSO NO LONGER THREAD PROPERLY INTO THE TRIAL SHELL. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236723 ↗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 21462905 ↗MalfunctionJul 17, 2024Break; Break
IT WAS REPORTED THAT THE THREADED PIECE OF LINER TRIAL BROKE OFF FROM THE REST OF THE TRIAL. THIS DID NOT OCCUR DURING THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19763157 ↗MalfunctionJul 11, 2024Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE DAMAGED LINER TRAIL WAS IDENTIFIED BY HOSPITAL PRIOR TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19719589 ↗MalfunctionApr 4, 2024Break; Break
IT WAS REPORTED THAT 36/58 NEUTRAL LINER TRIAL BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19044566 ↗MalfunctionMar 8, 2024Break; Break
IT WAS REPORTED THAT SCREW MECHANISM BROKE. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865235 ↗MalfunctionFeb 27, 2024Break; Break
IT WAS REPORTED THAT A PIECE OF THE LINER BROKE OFF WHEN REMOVING TRIAL LINER FROM TRIAL SHELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18788137 ↗MalfunctionJan 30, 2024Material Discolored; Contamination /Decontamination Problem; Material Discolored; Contamination /Decontamination Problem
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. WERE THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. THE PRODUCT WAS NOT USED FOR SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18611040 ↗MalfunctionDec 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE METAL SET SCREW POPPED OUT, LEAVING AN OPENING ON THE TOP OF THE TRIAL LINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18300766 ↗MalfunctionJul 17, 2023Break; Break
IT WAS REPORTED THAT THE LINER SCREW WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17332903 ↗MalfunctionJun 20, 2023Break; Break
IT WAS REPORTED THAT THE LINER TRIAL WAS BROKEN AND WILL NO LONGER STAY TOGETHER. ALL PIECES WERE REMOVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17163687 ↗MalfunctionJun 12, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED DURING STERILIZATION. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17105946 ↗MalfunctionMar 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THE PINNACLE TRIAL IS BROKEN. THE CENTRAL FIXATION SCREW HAS DETACHED FROM THE LINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16539801 ↗MalfunctionMar 6, 2023Break; Break
IT WAS REPORTED THAT THE 36 X 58 NEUTRAL TRIAL LINER WAS INSERTED INTO THE PINNACLE CUP FOR A TRIAL REDUCTION AND THE SCREW IN THE BOTTOM OF THE LINER TRIAL BROKE OFF. ALL PIECES WERE RETRIEVED FROM THE PATIENT AND IT DID NOT DELAY THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16486410 ↗MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn
ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16088140 ↗MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn
ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16088127 ↗MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn
ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED, AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16088117 ↗MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn
ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED, AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16088077 ↗MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn
ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16088049 ↗MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn
ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED, AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND, THEREFORE, DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16088022 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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