PINNACLE 2218-36-062Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 62OD x 36ID NEUT · Class 1
All models of PINNACLE (198)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy Pinnacle trial liner, a disposable plastic sleeve used to try hip implant sizes during surgery. The 28 reports mostly describe the liner breaking, cracking, wearing out, or becoming scratched and discolored, and sometimes no longer threading properly into its metal trial shell. No deaths and no injuries are reported, and most events happened outside surgery with no effect on the patient. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295101222), received between Dec 13, 2017 and Jun 18, 2025 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Break” (13 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
- Break13
- Naturally Worn11
- Material Discolored10
- Crack8
- Contamination /Decontamination Problem6
- Material Twisted/Bent3
- Scratched Material3
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Consequences Or Impact To Patient4
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
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 22286238 ↗MalfunctionOct 7, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT ON SEPTEMBER 30, 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 20386034 ↗MalfunctionMar 18, 2024Break; Break
IT WAS REPORTED THAT THE TOP OF THE LINER BROKE OFF WHEN REMOVING TRIAL LINER FROM SHELL.
Patient problems: Insufficient Information
MAUDE report 18920065 ↗MalfunctionMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT LINER TRIAL IS MISSING CONNECTOR PIECE. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18860181 ↗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 18611033 ↗MalfunctionJun 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE METAL INSERT IN THE TRIAL WAS POPPED OUT; THIS DID NOT HAPPEN DURING SURGERY AND THE REASON FOR DEFECTION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17163727 ↗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 17105923 ↗MalfunctionApr 5, 2023Break; Break
IT WAS REPORTED, THAT THE DURING TRIAL LINER INSERTION AND TIGHTENING OF THE LINER IN A 62 GRIPTION CUP, THE SURGEON HEARD A POP FROM THE TRIAL LINER. UPON REMOVING THE TRIAL LINER, WE OBSERVED THAT THE CENTRAL METAL THREADED POST BROKE FREE FROM THE REST OF THE ORANGE PLASTIC. IT WAS UNKNOWN ABOUT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16684083 ↗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 16088330 ↗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 16088317 ↗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 16088315 ↗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 16088311 ↗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 16088305 ↗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 16088226 ↗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 16088224 ↗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 16088213 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15624641 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15624603 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15624337 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15624139 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15624094 ↗MalfunctionJul 12, 2021Scratched Material; Scratched Material
IT WAS REPORTED THAT THE LINER IS DAMAGED WITH SCRATCHES ON THE FACE OF THE LINER. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12153784 ↗MalfunctionJun 30, 2021Material Twisted/Bent; Material Twisted/Bent
INSTRUMENTS REPORTED AND ISOLATED BY STERILE SERVICE. NO PATIENT CONSEQUENCE. VISIBLE WEAR DAMAGE IN THE SURFACE OF THE INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12096152 ↗MalfunctionApr 23, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
TEAM LEADER NURSE REPORTED 2 ATTUNE TRIALS MISSING THEIR BALSEALS AFTER STERILIZATION/CLEANING SAID THEY CAME OFF DURING THAT PROCESS. SHE ALSO REPORTED A PINNACLE LINER TRIAL THAT IS BROKEN DUE TO WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11719189 ↗MalfunctionAug 5, 2020Break; Break
IT WAS REPORTED THAT THE SCREW AT DOME OF LINER TRIAL IS SHEARED OFF. PIN ON THE END OF THE PINNACLE EXTRACTOR IS SHEARED OFF. FOUND IN SETS THAT WAY AND WE¿RE NOT USED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10370586 ↗
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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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