PINNACLE 2218-36-466Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295101420), received between Feb 11, 2019 and Oct 13, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (5 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE WAS A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597469 ↗
• MalfunctionOct 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE WAS A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597409 ↗
• MalfunctionOct 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE WAS A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597404 ↗
• MalfunctionOct 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE WAS A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597386 ↗
• MalfunctionOct 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE WAS A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597376 ↗
• 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 8736451 ↗
• 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 8324936 ↗