PINNACLE 2218-36-054Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 54OD x 36ID NEUTRAL · Class 1
All models of PINNACLE (198)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle neutral trial liner is a reusable hip implant sizing tool that hospital staff thread into a trial shell during surgery. Reports describe liners breaking, deforming or wearing out, screws stripping so parts no longer fit together, cross-threading during reprocessing, and contamination or cleaning problems. There are 46 reports, with no deaths and no injuries, and most note no effect on the patient.
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
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10603295101185), received between Aug 4, 2017 and Apr 30, 2026 — classified as 45 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
- Material Deformation9
- Contamination /Decontamination Problem7
- Device-Device Incompatibility7
- Naturally Worn7
- Scratched Material6
- Detachment of Device or Device Component4
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Consequences Or Impact To Patient6
- Insufficient Information5
- No Information3
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THE 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 25043084 ↗MalfunctionApr 30, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THE 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 25042998 ↗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 24955003 ↗MalfunctionApr 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT LINER TRIAL CAME APART WHEN SCREWING INTO CUP TRIAL. WILL NOT GO BACK TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24861141 ↗MalfunctionApr 13, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT PEGS ON DURALOC CURVED CUP IMPACTOR NO LONGER FIT WITH TIP OF THE IMPACTOR AND 54 36 NEUTRAL TRIAL LINER. INNER SCREW MECHANISM WAS STRIPPED THERE WERE NO BROKEN PIECES AND NO DELAYS OR COMPLICATIONS TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859491 ↗MalfunctionAug 8, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE LINER TRIAL SCREW IS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22749377 ↗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 22236669 ↗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 22236623 ↗MalfunctionFeb 5, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRIAL LINER WAS WORN AND NOT PROPERLY THREADING INTO LINER. THERE WAS NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21317036 ↗MalfunctionJul 26, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
PINNACLE TRIAL LINERS REQUIRE REPLACEMENT DUE TO WEAR AND TEAR AND NOT PROPERLY SCREWING INTO THE TRIAL SHELL. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19843569 ↗MalfunctionJun 13, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE 36X54 LINER TRIAL IS STRIPPED, NOT THREADING INTO CUP. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19528402 ↗MalfunctionMar 7, 2024Break; Break
IT WAS REPORTED THAT BOTH LINERS WERE BEATEN UP AND HAVE ARDS MISSING. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18855210 ↗MalfunctionFeb 13, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE LINER TRIAL HAS SCRATCHES AND SOME NORMAL WEAR AND TEAR. THE TRIAL DID NOT BREAK AND THERE WAS NO TIME ADDED TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18698075 ↗MalfunctionJan 30, 2024Material Discolored; Contamination /Decontamination Problem; Material Discolored; Contamination /Decontamination Problem
IT WAS REPORTED THAT DEVICE COLOR FADED AFTER STERILIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18611046 ↗MalfunctionNov 6, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED. AND STATED, THAT THERE WAS NO SURGICAL DELAY AND ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18074031 ↗MalfunctionSep 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PIECE OF THE LINER TRIAL THAT SCREWS IN SEPARATED FROM THE LINER. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17798883 ↗MalfunctionSep 14, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE LINER TRIAL CRACKED AND PIECES OF PLASTIC CAME OFF. ALL PARTS ARE ACCOUNTED.
Patient problems: Insufficient Information
MAUDE report 17743527 ↗MalfunctionAug 31, 2023Crack; Crack
IT WAS REPORTED THAT THE CUP LINER TRIAL WAS DAMAGED BY CUP CUTTER AND IS CRACKED IN ONE PIECE. SURGEON REVISED HIP AND WAS REMOVING THE CUP. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 17660722 ↗MalfunctionAug 16, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE TRIAL LINER IS WORN AND CROSS THREADED WHEN ATTEMPTED TO THREAD INTO THE SHELL IMPLANT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17557701 ↗MalfunctionMay 31, 2023Break; Break
DEVICE WAS REPORTED FOR UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 17031453 ↗MalfunctionMay 9, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSTRUMENTS BROKE INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16898317 ↗MalfunctionMay 1, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE POLY TRAIL WAS WORN DOWN AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16847003 ↗MalfunctionDec 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE 54 MM N TRIAL'S CENTER METAL PIECE WOULD NO LONGER RETAIN IN THE POLY TRIAL DUE TO THE LOCKING MECHANISM. THE LINER TRIAL WAS BEING RETURNED. NO TIME WAS ADDED TO THE CASE. PATIENT OUTCOME WAS NOT IMPACTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15902489 ↗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 15628765 ↗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 15628671 ↗
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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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