PINNACLE 2218-32-148Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER +4 10 DEGREE 32mm ID 48mm 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 plastic sizing template used during hip replacement surgery to fit and test the real implant before it goes in. Most of the 27 reports describe the liner wearing out, getting scratched, cracking or breaking, and sometimes parts such as the clip or set screw coming loose or detaching; a few mention a foreign body found on follow-up imaging, with no reported injuries or deaths. 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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295100812), received between Oct 31, 2018 and Jul 10, 2025 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (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
- Naturally Worn12
- Scratched Material10
- Break8
- Crack3
- Detachment of Device or Device Component3
- Device-Device Incompatibility3
- Material Integrity Problem2
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient7
- Foreign Body In Patient1
- No Code Available1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN DURING SURGERY. UPON MANUFACTURERS INVESTIGATION IT WAS NOTED THAT THE DEVICE WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22472186 ↗MalfunctionMay 21, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED DURING A FOLLOW-UP RADIOLOGICAL EXAMINATION, POST TOTAL HIP REPLACEMENT SURGERY, A FOREIGN BODY WAS FOUND IN THE SURGICAL AREA. NO SERIOUS HEALTH CONSEQUENCES OR REVISION PROCEDURES FOR THE PATIENT WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 22059633 ↗MalfunctionFeb 3, 2025Crack; Material Integrity Problem; Crack; Material Integrity Problem
IT WAS REPORTED THAT SOME INSTRUMENTS WERE CRACKED AND DAMAGED. NO IMPACT TO PATIENT; NO SURGICAL DELAY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21295205 ↗MalfunctionJan 29, 2025Crack; Crack
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO REPORTED DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21263366 ↗MalfunctionOct 15, 2024Break; Material Deformation; Naturally Worn; Scratched Material; Break; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT ON (B)(6) 2024, THERE WAS A BROKEN AND WORN PINNACLE 32MM +4/10 DEGREE LINER TRIAL. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20451916 ↗MalfunctionAug 28, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20090938 ↗MalfunctionDec 7, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE CIR CLIP SECURING SCREW INTO THE LINER TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18282866 ↗MalfunctionSep 15, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE HEX SET SCREW IS STRIPPED ON THE TRIAL LINER. 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 17757273 ↗MalfunctionJul 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TRIAL FELL APART, NO PATIENCE CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17328018 ↗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 17190000 ↗MalfunctionJun 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
BLIND UNIT RECEIVED IN LOCAL STOCK MARKED WITH RED TAPE WITHOUT PC IDENTIFICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17083043 ↗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 16663919 ↗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 16022968 ↗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 16022964 ↗MalfunctionOct 7, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
REQUEST BY HOSPITAL TO REPLACE 48MM AND 50MM ALTRX TRIAL LINERS AS SCREW THREADS ARE WORN, LEADING TO DIFFICULTY SEATING THE TRAIL LINER INTO THE PINNACLE SHELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15567012 ↗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 15551331 ↗MalfunctionDec 3, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE T-HANDLE IS CRACKED. 36 HEAD TRIAL IS WORN AND HAS DEEP GOUGES IN IT. LINER TRIAL'S METAL TIP HAS WORN THREADS AND IT WILL NO LONGER SCREW INTO THE CUP OR CUP TRIAL. NONE OF THESE HAPPENED DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12926172 ↗MalfunctionJun 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE FEMORAL IMPACTOR TIP HAS A CHIP, AND A CRACK AROUND THE ANTERIOR NOTCH. THE ARTIC SURF PIECE HAS A PIECE THAT HAS BROKEN OFF AND CRACKED. THERE ARE 2 LINER TRIALS THAT BOTH HAVE THE METAL PIECE IN THE CENTER WHICH ARE LOOSE AND THE RINGS ARE MISSING ON BOTH. THE ITEMS HAVE BEEN DECONTAMINATED AND SAVED, THEY WERE NOT FROM SURGICAL CASE, THEREFORE, DID NOT DELAY SURGERY. NO ONE WAS INJURED FROM THE ITEMS AND ALL INSTRUMENTS ARE BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12060575 ↗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 11982327 ↗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 11777602 ↗MalfunctionOct 19, 2020Break; Naturally Worn; Break; Naturally Worn
BROKEN AND WORN PINNACLE TRIAL LINER. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10696528 ↗MalfunctionOct 6, 2020Break; Break
ADDITIONAL INFORMATION RECEIVED STATED THAT THE LINER BROKE WHERE THE MIDDLE SCREW ON THE TRIAL WAS HELD ON WITH A METAL CLIP. THE MIDDLE SCREW, LOCKING RING AND THE PLASTIC AROUND THE SCREW BROKE OFF IN ONE PIECE, LEAVING A HOLE IN THE MIDDLE OF THE TRIAL AS THERE WAS NO WAY THE SCREW COULD ATTACH TO ANYTHING.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10636831 ↗MalfunctionJan 9, 2019Break; Break
IT WAS REPORTED THAT THE C-RING OF THE TRIAL LINER CAME OFF AND THE SCREW WAS NOT LOCKED BEFORE THE THA SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8232021 ↗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 8024141 ↗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 8024127 ↗
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 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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