PINNACLE 2218-36-460Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 60OD x 36ID + 4 NEUT · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295101390), received between Nov 1, 2018 and May 19, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (5 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
- Contamination /Decontamination Problem5
- Naturally Worn5
- Scratched Material5
- Break2
- Material Discolored1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Break
IT WAS REPORTED THAT TRIAL LINER BROKE. NO ADVERSE EVENT, NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216193 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15626629 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15626628 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15626405 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15626316 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15626205 ↗MalfunctionJun 26, 2019Material Discolored; Naturally Worn; Scratched Material; Material Discolored; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE LINERS ARE TOO WORN OUT TO BE USED IN SURGERY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8736445 ↗MalfunctionDec 28, 2018Break; Break
IT WAS REPORTED THAT THE PIN TRL +4 NEUT 600DX36ID THREADS HAVE BROKEN OF THE TRIAL DURING INSERTION OF THE CUP. ALL PARTS WERE RETRIEVED FROM THE PATIENT AND THE SURGERY WAS NOT EXTENDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8203168 ↗MalfunctionNov 1, 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 8030774 ↗MalfunctionNov 1, 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 8030767 ↗MalfunctionNov 1, 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 8030761 ↗MalfunctionNov 1, 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 8030755 ↗
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- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
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- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
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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