PINNACLE 2218-36-066Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295101246), received between Dec 12, 2017 and Jun 18, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED SEVERAL PINNACLE TRIAL LINERS HAVE BEEN SCRATCHED DUE TO WEAR AND TEAR, AS WELL AS NO LONGER THREADING PROPERLY INTO THE TRIAL SHELL. NO PATIENT CONSEQUENCES (B)(4) ARE RELATED TO EACH OTHER. THIS PC HAS BEEN CREATED TO CAPTURE ADDITIONAL IP'S FROM (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286374 ↗
• MalfunctionAug 6, 2024Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED: 1. NO REPORTED SURGICAL DELAY. 2. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917037 ↗
• MalfunctionJun 12, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED DURING STERILIZATION. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106007 ↗
• 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 15625037 ↗
• 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 15625015 ↗
• 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 15625006 ↗
• 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 15624915 ↗
• 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 15624775 ↗
• MalfunctionMar 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT NOTHING HAPPENED DURING THE CASE. WHEN THEY WENT TO RESET THE INSTRUMENTS THE POLY TRIAL HAD A STAIN THAT WOULD NOT COME OFF BY WASHING IT AND INSTRUMENT TRAY HAD PLASTIC THAT WAS CRACKING AND SPD STAFF DEEMED IT UNUSABLE. AGAIN NOTHING HAPPEN IN THE CASE. FYI THERE WAS NO LOT NUMBER ON THE INSTRUMENT TRAY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667078 ↗
• MalfunctionFeb 11, 2019Break; Material Disintegration; Component Missing; Break; Material Disintegration; Component Missing

  IT WAS REPORTED THAT THESE 2 PRODUCTS WERE FOUND IN SET MISSING THE METAL SCREW IN PIECE. THEY WERE NOT USED IN THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8324929 ↗
• MalfunctionDec 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PINNACLE CUP LINER TRIALS ARE OLD, WORN COLORS/CAN'T READ NUMBERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7109098 ↗