PINNACLE 2218-36-060Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 60OD x 36ID NEUT · 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 liner used to try hip implant sizes during surgery. The 55 reports mostly describe the liner breaking, cracking, warping or wearing out with repeated use, plus discoloration, scratches and sterilization concerns; many note no effect on the patient. No deaths or injuries are reported. 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
- 57
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10603295101215), received between Dec 12, 2017 and Sep 14, 2026 — classified as 57 malfunctions.
The most frequently reported specific device problem is “Break” (28 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
- Break28
- Naturally Worn17
- Crack11
- Material Discolored10
- Scratched Material7
- Contamination /Decontamination Problem6
- Detachment of Device or Device Component4
- Device-Device Incompatibility3
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Consequences Or Impact To Patient14
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753479 ↗MalfunctionSep 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753477 ↗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 50753470 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THE INSTRUMENTS WERE GETTING COMPLAINTS FROM MULTIPLE DOCTORS DUE TO THE WEAR AND TEAR. IT DID NOT HAPPENED IN SURGERY. (B)(4). CAPTURES ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24453606 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE RING HOLDING THE LINER FELL OFF AND INSTRUMENTS HAVE WEAR AND TEAR DUE TO OVER THE YEARS OF USE. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429035 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE RING HOLDING THE LINER FELL OFF AND INSTRUMENTS HAVE WEAR AND TEAR DUE TO OVER THE YEARS OF USE. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429034 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE RING HOLDING THE LINER FELL OFF AND INSTRUMENTS HAVE WEAR AND TEAR DUE TO OVER THE YEARS OF USE. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429030 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT 36/60 NEUTRAL LINER TRIAL WAS BROKEN. PLASTIC AROUND SCREW WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23559782 ↗MalfunctionJul 28, 2025Crack; Crack
IT WAS REPORTED THAT A CRACK IS FOUND IN TRIAL LINER WHEN STERILIZING. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22630725 ↗MalfunctionJul 15, 2025Break; Break
IT WAS REPORTED THAT THE 60MM LINER TRIAL THREADS BROKE WHEN REMOVING FROM THE CUP. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22505759 ↗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 22286195 ↗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 22237468 ↗MalfunctionOct 7, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT ON (B)(6) 2024 , THE LINER TRIALS WERE WORN AND WOULD NOT PROPERLY THREAD INTO CUP. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20386020 ↗MalfunctionJun 20, 2024Break; Break
IT WAS REPORTED THAT LINER TRIAL WAS BROKEN. PLASTIC STARTING TO FLAKE OFF.
Patient problems: Insufficient Information
MAUDE report 19573944 ↗MalfunctionApr 12, 2024Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN 60MM PINNACLE NEUTRAL TRIAL LINER. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101578 ↗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 18611031 ↗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 17106022 ↗MalfunctionApr 4, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
DR. WAS PERFORMING A TOTAL HIP REPLACEMENT, HE REAMED THE ACETABULUM AND IMPLANTED THE DEFINITIVE ACETABULA CUP AND THEN SCREWED IN A SIZE 58 NEUTRAL TRIAL LINER. ONCE HE COMPLETED THE FEMORAL PREPARATION HE REDUCED THE JOINT TO TRIAL THE STABILITY OF THE HIP JOINT. HIP JOINT WAS UNSTABLE SO HE WANTED TO REMOVE THE NEUTRAL TRIAL LINER BUT IT WOULD NOT DISASSOCIATE. AFTER A NUMBER OF ATTEMPTS HE MANAGED TO GET IT TO DISASSOCIATE BUT DAMAGED THE TRIAL LINER IN THE PROCESS. CENTRAL SCREW OF THE TRIAL BROKE OFF. THERE WAS A TEN MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16673205 ↗MalfunctionApr 3, 2023Scratched Material; Scratched Material
IT WAS REPORTED THAT INSTRUMENTS DAMAGED DURING STERILIZATION. ALL OF THE POLYS ARE SCRATCHED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16663912 ↗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 16088612 ↗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 16088266 ↗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 16088214 ↗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 16088212 ↗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 16088190 ↗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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16088137 ↗
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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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