PINNACLE 2218-36-452Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 52OD x 36ID + 4 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 reports mostly describe the trial liner breaking, chipping, wearing, or loosening during surgery, sometimes requiring a replacement device, with no reported patient harm. There are 77 malfunction reports, no deaths, and no injuries. 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
- 77
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10603295101352), received between Jul 25, 2017 and Jun 12, 2026 — classified as 77 malfunctions.
The most frequently reported specific device problem is “Break” (45 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
- Break45
- Scratched Material12
- Detachment of Device or Device Component10
- Naturally Worn7
- Contamination /Decontamination Problem5
- Crack3
- Appropriate Device Problem Term/Code Not Available2
- Component Missing2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Consequences Or Impact To Patient34
- No Information6
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Break
IT WAS REPORTED THAT PINNACLE ACETABULAR LINER TRIALS HAD BROKEN .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488655 ↗MalfunctionMar 10, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE IS REPORTED DUE TO WEAR AND TEAR OVER THE YEARS. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24560166 ↗MalfunctionNov 4, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE PIN TRL LNR DEVICE POLY TRIAL THREADED INSERT WAS DAMAGED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23464118 ↗MalfunctionAug 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TRIAL LINER 52+4 WAS FOUND TO BE MISSING THE SCREW RETAINING CLIP PREOPERATIVELY. USED WITHOUT CLIP. AFFECTED SIDE: RIGHT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22817258 ↗MalfunctionMay 5, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE TRIAL LINER IS UNUSABLE; THE CENTRAL PIECE IS LOOSE. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21960289 ↗MalfunctionJan 6, 2025Break; Break
IT WAS REPORTED THAT THE LINER TRIAL PIECE CHIPPED OFF. ALL THE PIECES WERE RECOVERED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21080867 ↗MalfunctionOct 9, 2024Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
IT WAS REPORTED THAT THE SURGEON WANTED WORN, DULL AND UNREADABLE TRIALS REPLACED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410323 ↗MalfunctionApr 19, 2024Break; Break
IT WAS REPORTED THAT POLY TRIAL BROKE. ALL PIECES WERE RECOVERED.
Patient problems: Insufficient Information
MAUDE report 19145260 ↗MalfunctionMar 28, 2024Break; Break
IT WAS REPORTED THAT THE LINER TRAIL BROKE AT JUNCTION POINT OF SCREW WHEN TRAILING. ALL PIECES RETRIEVED WITHOUT ADDITIONAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18994657 ↗MalfunctionNov 13, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT TRIAL LINERS, SCREW BIT HAS COME OFF, DOME DRILLS TIP WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18124529 ↗MalfunctionAug 22, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED. STATES, THAT NO ADVERSE EFFECT ON THE PATIENT. IT WAS BROKEN INTO 2 PIECES. ALL PIECES WERE RETRIEVED AND COUNTED FOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17598473 ↗MalfunctionAug 15, 2023Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIAL LINER IS SCRATCHED/GOUGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17550684 ↗MalfunctionJan 30, 2023Break; Break
IT WAS REPORTED THAT THE METAL PIECE OF LINE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16264872 ↗MalfunctionDec 8, 2022Break; Break
PATIENT WAS REVISED DUE TO FRACTURE OF THE LINER AT SUPERIOR RIM OF PINNACLE SHELL, RESULTING IN HEAD ARTICULATING AGAINST METAL SHELL INSTEAD OF POLYETHYLENE. POLY WAS REMOVED AND REPLACED WITH NEW LINER/NEW FEMORAL HEAD. ADDITIONALLY, WHEN ATTEMPTING TO TRIAL PINNACLE LINER, THE LOCKING SCREW BROKE THRU THE TRIAL AND COULDN¿T BE USED. ALL PIECES OF THAT WERE RETRIEVED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15940286 ↗MalfunctionDec 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PINNACLE LINER TRIAL CENTRAL SCREW BROKE OUT OF THE LINER TRIAL. REPLACEMENT NEEDED. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15928715 ↗MalfunctionOct 31, 2022Break; Break
IT WAS REPORTED THAT THE TRIAL LINER BROKE WHILE PUTTING IT IN THE CUP. THE SCREW TIP POPPED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15700639 ↗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 15624998 ↗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 15624975 ↗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 15624961 ↗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 15624894 ↗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 15624864 ↗MalfunctionFeb 8, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
INSTRUMENTS ARE BROKEN. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13482080 ↗MalfunctionJan 13, 2022Break; Break
IT WAS REPORTED THAT THE 52X36 +4N LINER TRIAL BROKE DURING TRIALING. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13251412 ↗MalfunctionDec 2, 2021Break; Break
IT WAS REPORTED THAT THE T-HANDLE CRACKED ON MIDDLE OF HANDLE. THE CENTER RING WAS MISSING OUT OF POLY TRIAL, METAL RING BROKE. RING, AND CENTER SCREW WERE DISPOSED. THE POLY TRIAL AND T-HANDLE WERE AVAILABLE FOR RETURN. THESE WERE HELD OUT OF DECONTAMINATE, NO ONE WAS INJURED FROM DAMAGED ITEMS, NO SURGERY WAS DELAYED BECAUSE DAMAGED ITEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12916171 ↗MalfunctionNov 29, 2021Break; Break
IT WAS REPORTED THAT THE PINNACLE POLY TRIAL BROKE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12882356 ↗
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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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