PINNACLE 2218-32-454Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295101048), received between Oct 30, 2018 and Apr 27, 2026 — 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.

• MalfunctionApr 27, 2026Break; Crack

  IT WAS REPORTED THAT DURING STERILE REPROCESSING IT WAS OBSERVED THAT THE TEETH ON QUICKSET ACE GRATER HEAD 54MM DEVICE HAD BECOME DULL AND CHIPPED. IT WAS FURTHER OBSERVED THAT THE PIN TRL LNR +4 NEUT 540DX32ID DEVICE WAS CRACKED AND CHIPPED. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008936 ↗
• 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 15625533 ↗
• 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 15625438 ↗
• 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 15625405 ↗
• 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 15625398 ↗
• 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 15625389 ↗
• 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 8020349 ↗
• 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 8020311 ↗
• 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 8020256 ↗
• 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 8020199 ↗