PINNACLE 2218-32-458Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295101062), received between Oct 10, 2018 and Oct 18, 2022 — classified as 10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE MDR REACHED OUT TO ME LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625798 ↗
• MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE MDR REACHED OUT TO ME LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625715 ↗
• MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE MDR REACHED OUT TO ME LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625665 ↗
• MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE MDR REACHED OUT TO ME LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625645 ↗
• MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE MDR REACHED OUT TO ME LETTING ME KNOW OF A GREEN RESIDUE BUILDING ON THE ACETABULAR TRIAL LINERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625620 ↗
• MalfunctionOct 30, 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 8020621 ↗
• MalfunctionOct 30, 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 8020609 ↗
• MalfunctionOct 30, 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 8020595 ↗
• MalfunctionOct 30, 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 8020590 ↗
• MalfunctionOct 10, 2018Break; Break

  32MM POLY TRIALS ARE SCRAPED AND CHIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952672 ↗