PINNACLE 2218-32-150Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER +4 10 DEGREE 32mm ID 50mm OD · 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 is a temporary plastic insert used during hip replacement surgery to try implant sizes and angles before the real part is fitted. The 32 reports mostly describe the liner breaking apart, cracking, or wearing down, with the metal center piece that screws into the cup coming loose or falling out, plus one report of deep scratches. There are 32 reports, with no deaths and one injury. 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
- 32
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295100829), received between Jan 15, 2018 and May 25, 2026 — classified as 1 injury, 31 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (12 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
- Scratched Material12
- Break10
- Naturally Worn8
- Crack4
- Detachment of Device or Device Component3
- Device-Device Incompatibility3
- Material Integrity Problem2
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient11
- Insufficient Information1
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2026Break
IT WAS REPORTED THAT THE PINNACLE 32X50 +4/10" BLUE LINER TRIAL COMPLETELY BROKE AND WAS UNABLE TO BE USED ANYMORE. IT WAS REPORTED THAT THE METAL INNER PART (THREADING ON DOME) BROKE OFF FROM LINER. IT WAS REPORTED THAT NO FRAGMENTS WERE GENERATED. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270855 ↗MalfunctionSep 10, 2025Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SURGEON WENT TO SCREW THE LINER TRIAL INTO THE CUP AND THE CENTER LOCKING MECHANISM CRACKED AND SEPARATED FROM THE PLASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23019939 ↗MalfunctionAug 15, 2025Crack; Crack
IT WAS REPORTED THAT THE DEVICE WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22815451 ↗MalfunctionAug 28, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091091 ↗MalfunctionNov 17, 2023Detachment of Device or Device Component; Scratched Material; Detachment of Device or Device Component; Scratched Material
THE IMPLANT HAS BEEN REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT PIN TRL LNR 10D 50ODX32ID PRESENTS SEVERAL DEEP SCRATCHES ALL OVER THE OUTER SURFACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18159361 ↗MalfunctionJun 23, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT PINNACLE TRIAL LINERS WERE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17190017 ↗MalfunctionApr 21, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN SURGEON ATTEMPTED TO TRIAL A 50X 32 +4 10° LINER TRIAL, THE CENTER METAL PIECE OF THE TRIAL LINER THAT THREADS INTO THE TRIAL CUP WOULD NOT ENGAGE. THIS CENTRAL METAL PIECE THEN BECAME LOSE AND FELL OUT OF THE TRIAL LINER. ALL PARTS ARE RETURNING. SURGERY WAS NOT SIGNIFICANTLY DELAYED.
Patient problems: Insufficient Information
MAUDE report 16784491 ↗MalfunctionDec 21, 2022Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
MDR STAFF REPORTED WORN AND GOUGED PINNACLE 32MM LINER TRIALS. NO PATIENT CONSEQUENCE REPORTED. NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16022969 ↗MalfunctionDec 21, 2022Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
MDR STAFF REPORTED WORN AND GOUGED PINNACLE 32MM LINER TRIALS. NO PATIENT CONSEQUENCE REPORTED. NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16022967 ↗MalfunctionNov 30, 2022Break; Break
IT WAS REPORTED THAT THE PINN LINER TRIAL BROKE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15887278 ↗MalfunctionOct 6, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE SCREW COMPONENT IS STRIPPED AND DIFFICULT TO SEAT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15551373 ↗MalfunctionOct 6, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE SCREW COMPONENT IS STRIPPED AND DIFFICULT TO SEAT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15551320 ↗MalfunctionJan 21, 2022Break; Break
BROKEN LINER TRIAL IDENTIFIED BY CSSD STAFF. NO HEALTHCARE PROFESSIONAL ASSOCIATED WITH THIS CASE. NO FRAGMENTS CREATED, SURGERY WAS NOT DELAYED AS A RESULT. THIS IS PART OF A CONSIGNMENT SET AND THE INSTRUMENT HAS BEEN TAGGED OUT AND RETURNED TO THE OPERATIONS WAREHOUSE. 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 13313944 ↗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 12836617 ↗MalfunctionNov 12, 2021Break; Break
IT WAS REPORTED THAT THE REAMERS REQUESTED TO BE REPLACED. DULL. TRIAL LINERS ARE BROKEN. CENTRAL SCREW IS SEPARATED FROM PLASTIC. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12804215 ↗MalfunctionNov 12, 2021Break; Break
IT WAS REPORTED THAT THE REAMERS REQUESTED TO BE REPLACED. DULL. TRIAL LINERS ARE BROKEN. CENTRAL SCREW IS SEPARATED FROM PLASTIC. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12804154 ↗MalfunctionJun 11, 2021Scratched Material; Scratched Material
IT WAS REPORTED THAT THE LINERS APPEARS TO HAVE CRACKS AND SCRATCHES IN VARIOUS PLACES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11982320 ↗MalfunctionMay 5, 2021Crack; Scratched Material; Crack; Scratched Material
IT WAS REPORTED THAT THE LINERS APPEARS TO HAVE CRACKS AND SCRATCHES IN VARIOUS PLACES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11777624 ↗MalfunctionApr 28, 2021Scratched Material; Scratched Material
NOTIFIED BY CSSD OF SCRATCHED PINNACLE LINER TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11739700 ↗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 11497394 ↗InjuryJan 29, 2020Break; Material Twisted/Bent; Scratched Material; Break; Material Twisted/Bent; Scratched Material
FOUND THE LINER TRIAL BROKEN. HE NOTIFIED DR. (B)(6) IMMEDIATELY OF THE BROKEN TRIAL. HE MET WITH THE FAMILY AND THEY DECIDED ,THEY WANTED THE PIECE TAKEN OUT. AT THE END OF HIS DAY AFTER 5 CASES, HE BROUGHT THIS PATIENT BACK TO SURGERY FOR THE REMOVAL. THE SURGERY TIME FOR THE REVISION WAS 88 MINUTES.
Patient problems: No Code Available; Not Applicable
MAUDE report 9643984 ↗MalfunctionFeb 1, 2019Break; Break
DURING TOTAL HIP REPLACEMENT CASE I NOTICED THAT A LINER TRIAL 32/50MM +4/10DEGREE - ITEM REF# WAS DAMAGED (THE SILVER SCREW PART AT THE APEX OF THE DOME HAD BROKEN OFF FROM THE PLASTIC LINER TRIAL (NOT BROKEN DURING CASE BUT DISCOVERED ITEM DAMAGED IN TRAY). THIS WAS THE ONE THE SURGEON NEEDED. A SECOND TRAY OF LINER TRIALS WERE OPENED AND A REPLACEMENT ITEM SOURCED AND THEREFORE NO IMPACT TO PATIENT OUTCOME OR DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8298491 ↗MalfunctionNov 5, 2018Crack; Crack
IT WAS REPORTED THAT DURING TRIALING THE METAL SCREW PART OF 2 LINER TRIALS BROKE. ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8039777 ↗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 8025490 ↗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 8025458 ↗
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
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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