PINNACLE 2218-36-052Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 52OD x 36ID NEUTRAL · 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 neutral, screw-in plastic trial piece used to size a hip implant before the real component is placed during hip replacement surgery. The 55 reports mostly describe the liner breaking, bending, scratching, or cross-threading so it no longer fits its shell, sometimes halting the trial and delaying surgery. No deaths and no injuries are described. There are no recalls naming 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
- 55
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10603295101178), received between Aug 4, 2017 and Jul 17, 2026 — classified as 55 malfunctions.
The most frequently reported specific device problem is “Break” (19 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
- Break19
- Device-Device Incompatibility9
- Material Deformation9
- Naturally Worn8
- Scratched Material7
- Contamination /Decontamination Problem6
- Crack5
- Detachment of Device or Device Component4
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Consequences Or Impact To Patient7
- No Information3
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2026Break
IT WAS REPORTED PRODUCT DAMAGE DOCUMENTED HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25858896 ↗MalfunctionJun 9, 2026Break
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE, THE PINNACLE ACETABULAR LINER TRIALS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25449452 ↗MalfunctionMay 19, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT WHEN TRIALING WITH POLY, IT WAS DISCOVERED THAT THE TRIAL LINER WAS BENT AND THE HEAD TRIAL WOULD NOT GO INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216074 ↗MalfunctionApr 30, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THE REPROCESSING STAFF NOTICED THAT THESE TRIAL LINERS WERE CROSS THREADED AND NO LONGER FIT INTO THE SHELL. NO PATIENT HARM; NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25042585 ↗MalfunctionApr 30, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THE REPROCESSING STAFF NOTICED THAT THESE TRIAL LINERS WERE CROSS THREADED AND NO LONGER FIT INTO THE SHELL. NO PATIENT HARM; NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25042248 ↗MalfunctionApr 22, 2026Device-Device Incompatibility; Material Deformation
MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THESE TRIAL LINERS WERE CROSS THREADED AND NO LONGER FIT INTO THE SHELL PIN TRL LNR NEUT 48ODX32ID (221832048): NOT APPLICABLE. PIN TRL LNR NEUT 50ODX32ID (221832050): NOT APPLICABLE. PIN TRL LNR NEUT 520DX36ID (221836052): NOT APPLICABLE. PIN TRL LNR NEUT 540DX36ID (221836054): NOT APPLICABLE. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954864 ↗MalfunctionMar 18, 2026Material Deformation
IT WAS REPORTED THAT DURING A PRIMARY TOTAL HIP ARTHROPLASTY, THE THREADED SCREW-IN CENTRAL PIECE OF THE PINNACLE 52 X 36 NEUTRAL TRIAL LINER WAS STRIPPED. THERE WERE NO BROKEN PIECES, NO DELAYS, AND NO COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629713 ↗MalfunctionFeb 26, 2026Scratched Material
IT WAS REPORTED THAT 52 TRIAL WAS SCRATCHED AND DENTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456919 ↗MalfunctionFeb 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY SURGICAL PROCEDURE, IT WAS DETERMINED THAT THE PIN TRL LNR NEUT NEUTRAL LINER TRIAL BROKE. THE METAL SCREW IN THE MIDDLE FELL OUT. ALL BROKEN PIECES WERE COLLECTED AND REMOVED FROM THE FIELD. THERE WERE NO DELAYS. THERE WERE NO COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24238081 ↗MalfunctionSep 4, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE DAMAGE WAS NOTICED TO THREAD OF LINER TRIAL DURING DEMO WITH SURGEON BY REP. WHEN ATTEMPTING TO SCREW TRAIL LINER INTO TRIAL CUP FOR DEMO THE THREAD WOULD NOT CATCH AND APPEARS TO HAVE BEE CROSS THREADED. DAMAGED DID NOT AFFECT A PATIENT AS IT WAS NOT NOTED DURING SURGEON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963773 ↗MalfunctionJul 3, 2025Crack; Crack
IT WAS REPORTED THAT THE CRACKED POLY TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22396536 ↗MalfunctionJun 17, 2025Material Deformation; Scratched Material; Material Deformation; Scratched Material
IT WAS REPORTED THE PINNACLE TRIAL LINERS HAVE BEEN SCRATCHED DUE TO WEAR AND TEAR; THEY ALSO NO LONGER THREAD PROPERLY INTO THE TRIAL SHELL. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236602 ↗MalfunctionJun 17, 2025Material Deformation; Scratched Material; Material Deformation; Scratched Material
IT WAS REPORTED THE PINNACLE TRIAL LINERS HAVE BEEN SCRATCHED DUE TO WEAR AND TEAR; THEY ALSO NO LONGER THREAD PROPERLY INTO THE TRIAL SHELL. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236499 ↗MalfunctionApr 25, 2025Crack; Crack
IT WAS REPORTED THAT THE HANDLE NO LONGER ATTACHES TO REAMERS PROPERLY, AND THE TRIAL LINER HAS BECOME CRACKED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21908546 ↗MalfunctionOct 30, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON (B)(6) 2024. THE 11 BROACH WOULD NOT ACCEPT ANY TRIAL NECK AND APPEARED TO BE SLIGHTLY BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20567815 ↗MalfunctionOct 9, 2024Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
IT WAS REPORTED THAT THE SURGEON WANTED WORN, DULL AND UNREADABLE TRIALS REPLACED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410511 ↗MalfunctionOct 7, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT ON (B)(6) 2024, THE LINER TRIALS WERE WORN AND WOULD NOT PROPERLY THREAD INTO CUP. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20386016 ↗MalfunctionSep 27, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED: A- CAN YOU PLEASE PROVIDE THE EXACT ALLEGATION AGAINST THE REPORTED DEVICE? SCREW WORN, NOT PROPERLY THREADING INTO THE CUP B- CAN YOU PLEASE PROVIDE THE LOT NUMBER OF THE REPORTED DEVICES? NOT READABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20327559 ↗MalfunctionAug 6, 2024Break; Break
IT WAS REPORTED THAT THE LINER TRIAL BROKE DURING CLEANING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917929 ↗MalfunctionJul 26, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
PINNACLE TRIAL LINERS REQUIRE REPLACEMENT DUE TO WEAR AND TEAR AND NOT PROPERLY SCREWING INTO THE TRIAL SHELL. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19843414 ↗MalfunctionJun 18, 2024Break; Break
THE TRIAL BROKE IN THE MIDDLE WHEN TRYING TO TIGHTEN IT INTO CUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19564113 ↗MalfunctionMay 14, 2024Break; Break
IT WAS REPORTED THAT THE SCREW MECHANISM BROKE. THE EVENT DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19313259 ↗MalfunctionJan 29, 2024Material Discolored; Contamination /Decontamination Problem; Material Discolored; Contamination /Decontamination Problem
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO B. WERE THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. THE PRODUCT WAS NOT USED FOR SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18596625 ↗MalfunctionJan 5, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT METAL RING THAT HOLDS THREADED PIECE IN PLACE BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18451471 ↗MalfunctionMay 30, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL LINER BROKE WITH THE RING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17020230 ↗
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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