PINNACLE 2218-32-058Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 58OD x 32ID NEUT · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle trial liner is a reusable plastic insert used to try different hip implant sizes during surgery. The 29 reports mostly describe the liner wearing out after repeated use — scratched, chipped or cracked, sometimes breaking when the surgeon hammered it into place, and no longer threading properly into the trial shell. No deaths or injuries are reported, and most mention no effect on the patient. No recalls name 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295100751), received between Jan 26, 2018 and Mar 26, 2026 — classified as 29 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break13
- Scratched Material10
- Contamination /Decontamination Problem5
- Naturally Worn5
- Device-Device Incompatibility2
- Detachment of Device or Device Component1
- Device Damaged by Another Device1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient9
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699888 ↗MalfunctionJun 18, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED SEVERAL PINNACLE TRIALS 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 22285346 ↗MalfunctionJun 17, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; 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 22236356 ↗MalfunctionAug 27, 2024Break; Break
IT WAS REPORTED THAT THE SURGEON IMPACTED LINER TRIAL AND BROKE IT.
Patient problems: Insufficient Information
MAUDE report 20075328 ↗MalfunctionMar 25, 2024Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT TRIAL LINER IS GOUGED. PATIENT STATUS/ OUTCOME / CONSEQUENCES ? WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF ? NONE. DEVICE IN POSSESSION OF ? NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.? TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18970648 ↗MalfunctionMay 10, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL LINER CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16905071 ↗MalfunctionJan 3, 2023Break; Break
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 16087501 ↗MalfunctionJan 3, 2023Break; Break
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 16087496 ↗MalfunctionJan 3, 2023Break; Break
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 16087484 ↗MalfunctionJan 3, 2023Break; Break
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 16087454 ↗MalfunctionJan 3, 2023Break; Break
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 16087445 ↗MalfunctionJan 3, 2023Break; Break
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 16087434 ↗MalfunctionJan 3, 2023Break; Break
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 16087413 ↗MalfunctionJan 3, 2023Break; Break
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 16087408 ↗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 15621586 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS GREEN RESIDUE ON THE TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15621577 ↗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 15621563 ↗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 15621494 ↗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 15621489 ↗MalfunctionJan 5, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE SCREW BECAME DISENGAGED FROM THE LINER TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118696 ↗MalfunctionOct 29, 2020Scratched Material; Scratched Material
SURGEON WAS REMOVING A 58 GRIPTION SECTOR CUP BECAUSE OF AN INFECTION. ZIMMER CUP EXTRACTOR WAS USED WITH 32X58N LINER TRIAL. THE OUTER EDGE OF THE LINER WAS CUT FROM THE CUP EXTRACTOR BLADE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10756223 ↗MalfunctionJan 6, 2020Device Damaged by Another Device; Scratched Material; Device Damaged by Another Device; Scratched Material
OUR 32MM 58 NEUTRAL LINER TRIAL WAS USED IN AN ACETABULAR REVISION FOR A G7 ACETABULAR CUP. WHILE PERFORMING THE SURGERY, THE EASY OUT CUP REMOVAL SYSTEM WAS USED. THE BLADES ON THE ZIMMER EASY OUT TOOL SCRATCHED AND DAMAGED OUR 32MM 58 NEUTRAL LINER. IT DID NOT BREAK INTO MULTIPLE PIECES - THE HOSPITAL DID REQUEST A REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9553765 ↗MalfunctionJul 3, 2019Material Deformation; Scratched Material; Material Deformation; Scratched Material
STAFF INDICATED THAT TWO 32 +1 HEAD TRIALS (253091000) AND A 32/58MM NEUTRAL LINER TRIAL (REF# 221832058) HAVE ALL BECOME GOUGED FROM REPEATED USE, AND REQUIRE REPLACEMENT. ITEMS HAVE BEEN DISCARDED. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8757802 ↗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 8026040 ↗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 8026005 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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