PINNACLE 2218-36-154Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 54OD x 36ID + 4 10 DEG · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle trial liner is a plastic sizing trial used during hip replacement surgery. The 31 reports describe liners with scratches, deep cuts and cracks, and screws that strip or won't hold, with some liners breaking during a case; a few were found damaged after sterilization or back at the office. None of the reports describe deaths or 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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295101277), received between Nov 8, 2017 and Mar 4, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (11 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
- Scratched Material11
- Break9
- Naturally Worn8
- Device-Device Incompatibility4
- Material Twisted/Bent4
- Material Integrity Problem3
- Component Missing2
- Corroded2
Patient problems
- No Consequences Or Impact To Patient15
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information3
- No Information2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE LINER WOULD NOT SCREW IN AND FINALLY PUSHED THROUGH AND BROKE DURING THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507679 ↗MalfunctionJul 23, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THERE WERE SCRATCHES ON TRIALS. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19806013 ↗MalfunctionJul 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SCREW CAME OUT OF TRIAL.
Patient problems: Insufficient Information
MAUDE report 19750266 ↗MalfunctionFeb 19, 2024Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn
IT WAS REPORTED THAT THE SCREW STRIPPED AND CAME OUT OF LINER TRIAL.
Patient problems: Insufficient Information
MAUDE report 18730320 ↗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 17105952 ↗MalfunctionApr 3, 2023Scratched Material; Scratched Material
IT WAS REPORTED THAT INSTRUMENTS DAMAGED DURING STERILIZATION. ALL OF THE POLYS ARE SCRATCHED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16663916 ↗MalfunctionDec 9, 2022Crack; Crack
IT WAS REPORTED THAT 2 POLY TRIALS WERE INSPECTED BEFORE A CASE AND WERE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15950509 ↗MalfunctionJul 6, 2022Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE TRIAL OLD, BADLY WORN WITH DEEP SCRATCHES, CUTS. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14935216 ↗MalfunctionMar 23, 2022Break; Crack; Break; Crack
TRIAL LINER CRACKED AND BROKE ON RIM. PIECES WERE RETRIEVED. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13861321 ↗MalfunctionNov 18, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED AS "TRIALS IN POOR CONDITION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12836666 ↗MalfunctionMay 21, 2021Break; Break
IT WAS REPORTED AS "BROKEN IN STERILIZATION". NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11864130 ↗MalfunctionMar 16, 2021Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent
IT WAS REPORTED THAT THE INSTRUMENTS WERE REPORTED DUE TO CORROSION AND WEAR. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11497421 ↗MalfunctionMar 16, 2021Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent
IT WAS REPORTED THAT THE INSTRUMENTS WERE REPORTED DUE TO CORROSION AND WEAR. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11497410 ↗MalfunctionMar 16, 2021Break; Break
IT WAS REPORTED THAT THE POLY TRIAL USED IN THIS CASE IS BROKEN AND NEEDS REPLACEMENT. THE METAL PART BROKE OFF FROM THE PLASTIC. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11496292 ↗MalfunctionMar 30, 2020Break; Component Missing; Break; Component Missing
IT WAS REPORTED THAT THE 54 X 36/10¿ PINNACLE LINER TRIAL SCREW RING BROKE OFF. THE RING WAS THROWN OUT BY MISTAKE BUT THE LINER AND SCREW ARE BEING RETURNED. NO PIECES WERE MISSING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9900187 ↗MalfunctionFeb 11, 2020Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT PLASTIC AROUND LOCKING RING OF THE PINNACLE 36MM +4 10 54 OD GOUGES. THE RING WONT STAY ON PROPERLY. THIS WAS NOTICED BY CSR AFTER MULTIPLE CASES OF THAT DAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9694921 ↗MalfunctionJan 16, 2020Break; Component Missing; Break; Component Missing
ADDITIONAL INFORMATION INDICATED THAT THE INDEX PROCEDURE DIDN¿T INVOLVE DEPUY PRODUCTS. THE REVISION CASE WAS REMOVAL OF A PROSTALAC AND REINSERTION OF IMPLANTS.
Patient problems: Not Applicable
MAUDE report 9597033 ↗MalfunctionJan 3, 2020Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON COULD NOT GET LINER TRIAL TO SEAT IN CUP DUE TO DEBRIS IN CENTER HOLE OF CUP. HE ELECTED TO REMOVE THE SCREW IN ORDER TO TRIAL. IN DOING THIS, HE DAMAGED THE TRIAL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9548908 ↗MalfunctionOct 3, 2019Loose or Intermittent Connection; Scratched Material; Unintended Movement; Loose or Intermittent Connection; Scratched Material; Unintended Movement
IT WAS REPORTED THAT THE LINER TRIAL NOTED BY CENTRAL STERILE DURING INSPECTION AS HAVING LINER SCREW IN MECHANISM "WOBBLY". THE LOCKING RING WILL NOT FULLY SEAT DOWN SECURELY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9152527 ↗MalfunctionSep 24, 2019Break; Material Disintegration; Material Twisted/Bent; Scratched Material; Break; Material Disintegration; Material Twisted/Bent; Scratched Material
ADDITIONAL INFORMATION RECEIVED THAT THE RING BENT AND CAME OFF BUT DID NOT BREAK IN PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9112319 ↗MalfunctionSep 3, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE CENTRAL STERILE CLEANING NOTIFIED OF A DAMAGED PINNACLE LINER TRIAL PART NUMBER 221836154. THE LOCKING WASHER IS BENT AND WILL NOT STAY IN POSITION. NEEDS REPLACEMENT ASAP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8957716 ↗MalfunctionAug 19, 2019Break; Break
IT WAS REPORTED THAT THE LINER TRIAL BROKE INTRAOPERATIVELY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8908279 ↗MalfunctionJun 26, 2019Material Discolored; Naturally Worn; Scratched Material; Material Discolored; Naturally Worn; Scratched Material
ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE LOT NUMBERS COULD NOT BE IDENTIFIED BECAUSE THESE WERE SO WORN AND SCRATCHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8736522 ↗MalfunctionNov 21, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PINNACLE TRIAL LINERS ARE WORN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8094222 ↗MalfunctionOct 30, 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 8021597 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- 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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