PINNACLE 2218-40-462Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295430223), received between Dec 15, 2017 and Jun 17, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2021Break; Break

  IT WAS REPORTED THAT THE METAL CAP BROKE WHEN TRYING TO SCREW IT INTO THE CUP. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12017496 ↗
• MalfunctionApr 12, 2018Break; Device Issue; Break; Device Issue

  IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY TRYING TO REMOVE THE LINER TRIAL. WOULD UNSCREW, BUT SEEMED STUCK IN THE SHELL. SURGEON NEEDED UP USING AN OSTEOTOME TO REMOVE IT. ALL PIECES WERE RETRIEVED. SURGICAL DELAY 2 MINUTES.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7424654 ↗
• MalfunctionDec 15, 2017Break; Break

  IT WAS REPORTED THAT THE SURGEON BROKE THE SCREW IN THE TRIAL LINER. ALL PIECES WERE RETRIEVED AND ACCOUNTED FOR FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7120867 ↗