PINNACLE 2218-36-458Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 58OD x 36ID + 4 NEUT · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle trial liner is a temporary surgical sizing component. The 24 reports describe wear over time, green residue or contamination, and parts cracking, breaking, coming loose, or going missing; no deaths or injuries were reported. No recalls name this device. Reports increased from 0 in the previous 12 months to 1 in the latest 12 months.
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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295101383), received between Nov 13, 2017 and Mar 10, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Naturally Worn6
- Scratched Material6
- Break5
- Contamination /Decontamination Problem5
- Detachment of Device or Device Component4
- Material Deformation3
- Appropriate Device Problem Term/Code Not Available1
- Cut In Material1
Patient problems
- No Consequences Or Impact To Patient12
- No Clinical Signs, Symptoms or Conditions11
- No Information1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE IS REPORTED DUE TO WEAR AND TEAR OVER THE YEARS. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24560193 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15626547 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15626524 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15626497 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15626427 ↗MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE TRIAL LINER HAS GREEN RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15626406 ↗MalfunctionAug 12, 2022Detachment of Device or Device Component; Illegible Information; Detachment of Device or Device Component; Illegible Information
IT WAS REPORTED THAT THE SCREW COMPONENT FELL OFF THE TRIAL. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15218105 ↗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 12060577 ↗MalfunctionJun 24, 2021Break; Break
IT WAS REPORTED THAT UPON OPENING A PINNACLE POLY TRIALS TRAY, IT WAS DISCOVERED BY THE SURGICAL TECH THAT A 2218-36-458 HAD A CHIP OUT OF IT. THIS TOOK PLACE PRIOR TO THE PATIENT BEING BROUGHT INTO THE ROOM FOR THE TOTAL HIP ARTHROPLASTY. UPON INSPECTION OF THE TRAY, THE SURGICAL TECH DID NOT FIND ANY FRAGMENTS. DURING THE CASE THAT PARTICULAR POLY TRIAL WAS NOT NEEDED AND WAS LEFT IN THE TRAY AND NEVER CAME IN CONTACT WITH THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12058242 ↗MalfunctionApr 8, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT NOTICED TO BE BROKEN PRIOR TO SURGERY. WAS NOT USED. METAL SCREW CAP CAME APART FROM POLY TRIAL. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11634038 ↗MalfunctionNov 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE METAL RING CAME OFF POLY TRIAL. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10920433 ↗MalfunctionNov 19, 2020Break; Break
NURSE REPORTED A BROKEN TRIAL LINER THAT REQUIRES REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10871254 ↗MalfunctionMay 11, 2020Break; Break
IT WAS REPORTED THAT BOTH PRODUCTS CONTAINED IN THIS DER BROKE DURING USE AND ARE NO LONGER FUNCTIONING. ALL PARTS WERE RETRIEVED. NO PIECES WERE LEFT IN PATIENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10043340 ↗MalfunctionJul 23, 2019Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
LINER TRIAL WORN AND SCRATCHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8815709 ↗MalfunctionJun 26, 2019Material Discolored; Naturally Worn; Scratched Material; Material Discolored; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE LINERS ARE TOO WORN OUT TO BE USED IN SURGERY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8736447 ↗MalfunctionNov 1, 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 8030739 ↗MalfunctionNov 1, 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 8030730 ↗MalfunctionNov 1, 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 8030726 ↗MalfunctionNov 1, 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 8030714 ↗MalfunctionOct 19, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE FACILITY HAS REQUESTED TO REPLACE ALL THE CUP TRIALS BECAUSE THEY ARE DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7985823 ↗MalfunctionMay 14, 2018Break; Break
IT WAS REPORTED THAT THE METAL CAP SEPARATED FROM THE POLY TRIAL WHILE THE DOCTOR WAS SCREWING IT INTO CUP IMPLANT. THE POLY TRIAL IS IN TWO PIECES. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7510500 ↗MalfunctionMar 12, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT WHEN ACETABULAR LINER WAS BEING INSERTED FOR TRAILING, THE SCREW IN THE LINER AND DURALOC SCREWDRIVER SHAFT WAS STRIPPED. SURGICAL DELAY OF 5 MINUTES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7331681 ↗MalfunctionDec 4, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT UPON SURGICAL EVALUATION, CUP LINERS WERE FOUND TO BE HEAVILY GOUGED AND SCARRED ALONG THE BOTTOM AND INSIDE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7081665 ↗MalfunctionNov 13, 2017Cut In Material; Material Integrity Problem; Cut In Material; Material Integrity Problem
IT WAS REPORTED THAT THE LINERS HAS SCARING INSIDE THE DIAMETER. ON (B)(6) 2017: EVALUATION OF THE RETURNED INSTRUMENTS FOUND DEEP GOUGES WITH PIECES OF MATERIAL MISSING. (B)(6).
Patient problems: No Information
MAUDE report 7024699 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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