PINNACLE 2218-32-448Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 48OD x 32ID + 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 is a reusable metal liner used to try implant sizes during hip replacement surgery. The 30 reports mostly describe liners that are scratched, cracked, gouged or worn out from repeated use, plus some with green residue or contamination that left them unusable. No deaths or injuries are reported. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295101017), received between Aug 15, 2017 and Jun 10, 2025 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (9 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 Material9
- Break8
- Naturally Worn7
- Contamination /Decontamination Problem5
- Crack4
- Material Deformation3
- Detachment of Device or Device Component2
- Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient12
- No Information2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2025Crack; Crack
IT WAS REPORTED THAT THE BROACH HANDLES ARE LOOSE. PINNACLE LINER IS CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177511 ↗MalfunctionApr 5, 2023Scratched Material; Scratched Material
IT WAS REPORTED THE INSTRUMENTS ARE SCUFFED, SCRATCHED AND DAMAGED. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16682309 ↗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 16022966 ↗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 16022961 ↗MalfunctionOct 24, 2022Crack; Crack
IT WAS REPORTED THAT THE PINNACLE LINER TRIAL IS CRACKED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15658945 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS GREEN RESIDUE ON THE TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15621609 ↗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 15621592 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE IS GREEN RESIDUE ON TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15621536 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS GREEN RESIDUE ON TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15621529 ↗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 15621508 ↗MalfunctionJul 20, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENT WAS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15064542 ↗MalfunctionJan 26, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT THE TRIAL LINER SCREW SEPARATED FROM CLIP. CLIP BENT AND WILL NOT SECURE SCREW IN TRIAL POLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13357462 ↗MalfunctionNov 8, 2021Crack; Material Deformation; Crack; Material Deformation
IT WAS REPORTED THAT THE LINER TRIAL IS CRACKED AND RESTRAINING RING IS BENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12770352 ↗MalfunctionOct 29, 2021Break; Break
IT WAS REPORTED THAT THE LINER TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12721596 ↗MalfunctionMay 5, 2021Crack; Scratched Material; Crack; Scratched Material
IT WAS REPORTED THAT THE LINERS APPEARS TO HAVE CRACKS AND SCRATCHES IN VARIOUS PLACES. NO SURGICAL DELAYS OR PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11777682 ↗MalfunctionJan 28, 2021Detachment of Device or Device Component; Illegible Information; Detachment of Device or Device Component; Illegible Information
IT WAS REPORTED THAT THE POLY LINER TRIALS CAN¿T BE READ WITH SIZES ANYMORE OR THE CENTER SCREW HAS COME OFF OF THE 32MM SIZES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11247798 ↗MalfunctionOct 13, 2020Break; Break
IT WAS REPORTED THAT LINER TRIAL BROKE. NO SURGERY DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10670505 ↗MalfunctionJul 22, 2020Break; Break
IT WAS REPORTED THAT THE PINNACLE LINER TRIALS HAVE THE PLASTIC TIP AREA BROKEN OFF IN THE DOME WHERE THE SCREW ATTACHES. THE DRILL GUIDE HAS A BURR INSIDE WHERE THE BIT RUNS THROUGH. THE DEPTH GAUGE AND SCREW FORCEPS ARE BOTH BENT AND CAN¿T BE FIXED. THE REAMER HANDLE WON¿T PULL BACK TO ALLOW INSERTION OF THE GRATER. NONE OF THESE ITEMS WERE USED IN A CASE THEY WERE FOUND IN THE SETS THIS WAY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10310658 ↗MalfunctionOct 22, 2019Break; Component Missing; Break; Component Missing
IT WAS REPORTED THAT THE SCREW TIP OF LINER TRIAL BROKE OFF DURING SURGERY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9221238 ↗MalfunctionSep 16, 2019Device Slipped; Device Slipped
IT WAS REPORTED THAT THE TREADS ARE STRIPPED ON THE LONG HANDLE PINNACLE IMPACTOR AND THE RETAINING CLIP IS LOOSE ON THE 48MM +4 NEUTRAL LINER TRIAL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9071080 ↗MalfunctionAug 2, 2019Break; Break
WHILE TRIALING A HIP CONSTRUCT ON THE RIGHT SIDE OF THE PATIENT DR. REMARKED THAT THE TRIAL 48/32 +4 NEUTRAL LINER WAS MOVING INSIDE THE PINNACLE SECTOR II SZ 48 SHELL THAT HAD BEEN IMPLANTED DESPITE HAVING SCREWED IN THE TRIAL LINER. DR. DISLOCATED THE HIP CONSTRUCT LEAVING THE 5 HI SUMMIT BROACH IN THE PATIENT AND HANDING OVER THE SUMMIT 5 HI TRIAL NECK AND 32 +1 ARTICULEZE TRIAL HEAD TO THE SCRUB TECH. DR. REMOVED THE OUT BROKEN PIECE WITH A KOCHER AND THEN USED A DURALOC SCREWDRIVER HANDLE AND CARDAN SCREWDRIVER TO REMOVE THE SECOND PIECE OF THE BROKEN TRIAL LINER. REP THEN WENT DOWNSTAIRS TO RETRIEVE A SECOND HIGH PERFORMANCE PINNACLE TRIAL LINER TRAY. THE CASE WAS DELAYED 5 MINUTES WHILE REP RETRIEVED ANOTHER TRAY OF TRIAL. ALL PIECES WERE RECOVERED.
Patient problems: Not Applicable
MAUDE report 8855197 ↗MalfunctionFeb 15, 2019Material Deformation; Scratched Material; Material Deformation; Scratched Material
IT WAS REPORTED THAT UPON INSPECTION OF INSTRUMENTS IT WAS NOTICED THAT SOME WERE SCRATCHED AND WORN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8344114 ↗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 8023907 ↗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 8023866 ↗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 8023859 ↗
Other TEMPLATE devices
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- 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 13, 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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