PINNACLE 2218-28-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295100218), received between Feb 19, 2021 and May 9, 2023 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Crack; Crack

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE ITEM CRACKED. NOTHING WAS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898195 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615563 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615480 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615435 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615336 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615255 ↗
• MalfunctionNov 18, 2021Device-Device Incompatibility; Scratched Material; Unintended Movement; Device-Device Incompatibility; Scratched Material; Unintended Movement

  STAFF HAVE INDICATED A PINNACLE STRAIGHT CUP INSERTER HAS A STRIKE PLATE THAT HAS BROKEN OFF DUE TO SEVERAL USES OVER TIME/WEAR AND TEAR. A 28/52 TRIAL LINER THAT IS GOUGED AS WELL AS LOOSE AND WILL NO LONGER THREAD INTO THE TRIAL SHELL. ITEMS HAVE BEEN DISCARDED AND THEREFORE NO LOT #S AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834466 ↗
• MalfunctionApr 23, 2021Break; Break

  IT WAS REPORTED THAT THE 28X52 N LINER TRIAL WAS CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11719009 ↗
• MalfunctionFeb 19, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACETABULAR LINER TRAIL FOR PINNACLE CUP (PN 221828052) SIZE 28X52 N BROKE DURING INSERTION. SURGICAL DELAY 5 MINUTES. LINER AND PIECES REMOVED. PROCEDURE SUCCESSFULLY COMPLETED. NO CONSEQUENCE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350531 ↗