PINNACLE 2218-36-064Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295101239), received between Dec 12, 2017 and Jun 17, 2026 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY STAFF THAT THE TRIAL LINER WAS NO LONGER IN WORKING CONDITION. SCREWDRIVER NO LONGER FITS INTO THE TRIAL LINER AS IT IS STRIPPED. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534317 ↗
• 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 22286334 ↗
• MalfunctionJan 30, 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 18611027 ↗
• 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 17106035 ↗
• 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 15624456 ↗
• 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 15624269 ↗
• 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 15624144 ↗
• 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 15624132 ↗
• 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 15624116 ↗
• MalfunctionAug 5, 2022Material Deformation; Material Deformation

  DURING STERILIZATION THE LINERS WERE MELTED. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174613 ↗
• MalfunctionFeb 11, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE THREADED PORTION HAS DISSATTACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8325947 ↗
• MalfunctionMar 6, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SCREW SEPARATED FROM LINER TRIAL, THE INSTRUMENT WAS NOT USED IN SURGERY. ALL PIECES WERE RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7316840 ↗
• 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 7108964 ↗