PINNACLE 2218-36-152Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER +4 10 DEGREE 36mm ID 52mm 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 different sizes before the real implant goes in. Most of the 67 reports describe the liner breaking, cracking or coming apart, often while a surgeon was removing it from the cup, plus scratched or worn surfaces and threads that would not screw in properly. There are no deaths and one injury. Most reports say nothing was left in the patient and surgery finished without delay. 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
- 67
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10603295101260), received between Aug 4, 2017 and Mar 17, 2026 — classified as 1 injury, 66 malfunctions.
The most frequently reported specific device problem is “Break” (34 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
- Break34
- Scratched Material14
- Detachment of Device or Device Component12
- Naturally Worn7
- Material Deformation6
- Material Twisted/Bent5
- Crack4
- Entrapment of Device3
Patient problems
- No Consequences Or Impact To Patient33
- No Clinical Signs, Symptoms or Conditions27
- Insufficient Information4
- No Information4
- Foreign Body In Patient1
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Break
IT WAS REPORTED THAT THERE WAS A BROKEN 36 X 52 MM +4 10D LINER TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24619040 ↗MalfunctionMar 5, 2026No Apparent Adverse Event
IT WAS REPORTED THAT PIN TRL LNR 10D 520DX36ID REQUIRED REPLACEMENT OF A LINER TRIAL, WITH NO FURTHER SPECIFIC ALLEGATION PROVIDED. UPON VISUAL INSPECTION BY THE MANUFACTURER THE DEVICE WAS FOUND TO BE BROKEN.
Patient problems: Insufficient Information
MAUDE report 24523651 ↗MalfunctionSep 12, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE 52/36 +4/10 LINER INNER SCREW WAS NOT THREADING INTO THE IMPLANT EFFECTIVELY. IT SEEMED THAT SOME OF THE THREADS WERE STRIPPED. THE CASE WAS ONLY DELAYED BY A FEW MINUTES AS THEY TRIED SEVERAL TIMES TO THREAD IT IN. EVENTUALLY IT WENT IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23037542 ↗MalfunctionMar 3, 2025Crack; Crack
IT WAS REPORTED THAT THE PINNACLE TRIAL LINER CRACKED WHEN REMOVING IT FROM CUP.
Patient problems: Insufficient Information
MAUDE report 21507746 ↗MalfunctionJan 22, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL LINER HAS WORN ON THE EDGES. THERE WERE NO DELAYS TO SURGERY, NOTHING WAS LEFT IN THE PATIENT AND THERE WERE NO ADVERSE OUTCOMES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21209487 ↗MalfunctionOct 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT LOCKING RING CAME OFF OF THE TRIAL. ALL PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20581272 ↗MalfunctionOct 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A LINER TRIAL FELL APART WHILE SURGEON WAS REMOVING FROM CUP IN PATIENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20547088 ↗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 20410379 ↗MalfunctionDec 7, 2023Break; Break
IT WAS REPORTED THAT DURING SPD THE TRIALS FOUND BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18281992 ↗MalfunctionDec 7, 2023Break; Break
IT WAS REPORTED THAT DURING SPD THE TRIALS FOUND BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18281986 ↗MalfunctionNov 15, 2023Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component
DURING A TOTAL HIP ARTHROPLASTY, AFTER INSERTING THE TRIAL LINER INSERT, A PART OF THE TRIAL LINER INSERT BROKE OFF AND REMAINED WITHIN THE PATIENT¿S BODY. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION AS REPORTED TO ISRAELI MOH, IT IS AS TRANSLATED FROM THE LOCAL HEBREW FORM WITH ADDITIONAL INFORMATION: DURING THE OPERATION, THE SURGEON POSITIONED THE CUP COMPONENT AS ACCEPTABLE AND THEN MADE USE OF TRIAL TOOLS, WHICH ARE MULTI-USE TOOLS (FOUND IN THE HOSPITAL) DESIGNED TO ALLOW THE SURGEON TO VERIFY THE SUITABILITY OF THE ADDITIONAL COMPONENTS (IN TERMS OF SIZE AND ANGLE) BEFORE OPENING THE STERILE IMPLANTS AND IMPLANTING THEM. IN THIS FRAMEWORK, TRIAL LINER WAS USED, AMONG OTHER THINGS. UPON COMPLETION OF USING THE TRIAL TOOL, THE TRIAL TOOL WAS UNSCREWED AND THE SURGEON COMPLETED THE OPERATION WITH THE STERILE IMPLANTS. IN THE IMAGING TAKEN AFTER THE SURGERY WAS COMPLETED, A SMALL HORSESHOE-SHAPED METALLIC COMPONENT WAS OBSERVED NEAR THE LEFT ACETABULUM (ON THE PATIENT'S BODY NEAR THE SURGICAL AREA). FROM AN EXAMINATION CARRIED OUT IN THE OPERATING ROOM, IT WAS FOUND THAT THE AFOREMENTIONED METAL COMPONENT APPARENTLY DETACHED FROM THE OUTER SCREWING AREA OF THE TRIAL LINER
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 18139548 ↗MalfunctionNov 13, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED: A. DID IT BROKE INTO TWO OR MORE PIECES? 2 PIECES. B. WERE THERE ANY FRAGMENTS GENERATED? IF YES, WERE ALL THE PIECES RETRIEVED? NO FRAGMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18124445 ↗MalfunctionSep 28, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL LINER HAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17836508 ↗MalfunctionAug 15, 2023Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIAL LINER IS SCRATCHED/NICKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17550683 ↗MalfunctionAug 11, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL LINER WAS BROKEN. SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17512858 ↗MalfunctionAug 9, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
THE METAL RING AROUND THE BOLT OF THE LINER IS BENT AND ELEVATED PREVENTING THE LINER TRIAL FROM FULLY SEATING IN THE IMPLANT/TRIAL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17492496 ↗MalfunctionMay 4, 2023Material Discolored; Material Discolored
IT WAS REPORTED THAT CENTRAL STERILE HAS BROUGHT TO SALES REPRESENTATIVE ATTENTION SOME INSTRUMENTS THAT ARE BROKEN, AND NEED REPLACED. THESE INSTRUMENTS WERE NOT INVOLVED IN A SURGERY, THEY WERE NOTICED DURING ASSEMBLY AND INSPECTION. THE FEMORAL TRIAL HAS CRACK AT NOTCH, THE PINNACLE POLY LINER TRIALS, ONE IS DISCOLORED, THE OTHER HAS SHARP EDGES AROUND EDGE. SALES REPRESENTATIVE RETURNING ALL FOR FURTHER INSPECTION. NO ONE WAS INJURED, NO SURGERY INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16866863 ↗MalfunctionMar 1, 2023Break; Break
IT WAS REPORTED THAT THE 36X52 +4 10D BROKE AT THE SCREW AND COUPLING. TAPERED HEX SCREWDRIVER U-JOINT BROKE DURING SCREW INSERTION. THERE WAS A 30 MINUTES OF SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 16463972 ↗MalfunctionDec 21, 2022Crack; Crack
IT WAS REPORTED THAT THE INSTRUMENT DOES NOT MATE UP PROPERLY WITH THE HUDSON POWER ADAPTOR AND THE LINER TRIAL IS CRACKED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16024591 ↗MalfunctionSep 26, 2022Break; Break
IT WAS REPORTED THAT THE INNER LINER SCREW BROKE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15487140 ↗InjurySep 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A TOTAL HIP PROCEDURE, IT WAS NOTICED THAT THE TRIAL CUP LINER DISENGAGED WHERE THE SCREW ATTACHES TO THE RETAINING CLIP RESULTING IN THE CLIP RETAINING IN THE PATIENT. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON NEXT DAY FOR THE CLIP REMOVAL. THERE WAS A DELAY IN SURGERY AND LOOSENING ALSO EXPERIENCED TO THE LINER/THREADED SCREW/RETAINING CLIP.
Patient problems: Insufficient Information
MAUDE report 15340424 ↗MalfunctionApr 27, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
DURING A REVISION SURGERY THE LOCKING RING CAME OFF AFTER TRIALING. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY. DOE: (B)(6) 2022. AFFECTED SIDE: UNKNOWN SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14218679 ↗MalfunctionNov 29, 2021Break; Break
IT WAS REPORTED THAT THE LOCKING CLIP WAS BROKEN. ALL ITEMS WERE RETRIEVED. THE ACTUAL LOCKING CLIP WAS LOST IN DECONTAMINATION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12882572 ↗MalfunctionOct 8, 2021Break; Break
IT WAS REPORTED THAT THE FOUR FEMORAL TRIALS HAVE CRACKS ABOVE NOTCH THAT ARE GOING THROUGHOUT TRIAL. I HAVE A POLY LINER THAT THE INSIDE SCREW IS BROKEN. THESE WERE ALL CAUGHT BY DECONTAMINATION SO NO SURGERY WAS DELAYED, NO PATIENT INVOLVED. I AM RETURNING ALL 5 ITEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12599595 ↗MalfunctionOct 6, 2021Break; Break
THE ATTACHMENT RING FOR 2 POLY LINER TRIALS CAME APART DURING THE PROCEDURE. BOTH TIMES ALL 3 COMPONENTS OF THE TRIALS WERE RETRIEVED INCLUDING THE RETAINING CLIP ON THE BACK OF THE LINER TRIAL. (36X52 +4N [2218-364-52] AND 36X52 +4N-10* [2218-361-52]).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12584632 ↗
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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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