PINNACLE 2218-28-248Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295100430), received between Mar 2, 2022 and Dec 19, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT THE LINER BROKE WHEN POSITIONING IT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360381 ↗
• MalfunctionMar 2, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE THA SURGERY FOR OA WITH THE LINER TRIAL AND THE IMPACTOR TIP IN QUESTION. IN THE SURGERY, A GREEN FRAGMENT WAS FOUND DURING THE IMPLANTATION OF THE LINER TRIAL. ONLY THE LINER TRIAL AND THE IMPACTOR TIP ARE GREEN INSTRUMENTS IN THIS SURGERY. SINCE THERE IS A CHIP IN THE TAB OF THE LINER TRIAL, IT IS SUSPECTED TO BE A BROKEN PIECE OF THIS PART, BUT AN INVESTIGATION IS REQUESTED TO CLARIFY WHERE THE BROKEN PIECE ORIGINATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652842 ↗