PINNACLE 2218-28-452Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295100560), received between Nov 27, 2019 and Nov 27, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2019Break; Entrapment of Device; Scratched Material; Break; Entrapment of Device; Scratched Material

  THE 28/52+4NEUTRAL TRIAL LINER RING BECAME DISSOCIATED FROM THE TRIAL. THE TRIAL APPEARED IN TACT WHEN IT WAS PLACED ON THE MAYO STAND AFTER BEING REMOVED FROM THE PATIENT. WHEN INSTRUMENTS WERE BEING REPLACED AFTER THE CASE ENDED, IT WAS NOTICED THAT THE TRIAL WAS IN TWO PIECES. THE RING THAT HOLDS THEM TOGETHER WAS NOT IN TACT OR FOUND. BASED ON IMPLANT CT IMAGE AND X-RAYS, IT DOES NOT APPEAR THE RING IS IN THE PATIENT. HOWEVER, THE RING WAS NOT FOUND ANYWHERE IN THE ROOM. THERE IS A CHANCE THAT THE RING COULD BETWEEN THE POLY AND THE CUP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9385199 ↗