PINNACLE 2218-90-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295102335), received between Jun 19, 2018 and Jun 19, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 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.

• InjuryJun 19, 2018Difficult to Remove; Difficult to Remove

  FOR THIS SURGERY, CERAMIC INSERT (LINER) WAS REQUESTED, AND WHEN WE USED THE INSTRUMENTS TO INSERT THE CERAMIC LINER, WE HAD GREAT DIFFICULTY IN RELEASING THE IMPLANT FROM THE INSTRUMENTS. WE USED THE CORRECT TECHNIQUE BUT THE IMPLANT DID NOT EASILY GET LOOSE FROM THE INSTRUMENTS. THIS SITUATION GENERATED SURGEON DISSATISFACTION. THE INSTRUMENTAL ALSO SCRATCHED THE CERAMIC IMPLANT A BIT. FIND ATTACHED PHOTOS OF THE INSTRUMENTS WITH THE CODES OF EACH PIECE USED. IT GENERATED A DELAY IN SURGERY OF APPROXIMATELY 15 MINUTES. IT CAUSED NO INJURY TO THE PATIENT. (B)(6).

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

  MAUDE report 7614212 ↗