PINNACLE 2218-32-256Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295100942), received between Mar 12, 2018 and Aug 3, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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.

• MalfunctionAug 3, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT TRIAL LINER IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156849 ↗
• MalfunctionMar 12, 2018Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  TOTAL HIP REPLACEMENT - DAA - DR (B)(6), (B)(6) HOSPITAL. DR (B)(6) WAS HAVING DIFFICULTY IN BEING ABLE TO SEE THE MARKINGS ON THE TRIAL LINER DUE TO BEING HEAVILY SCRATCHED AS WELL AS BEING FADED. THE GRUB SCREW ALSO FELL OUT WHEN REMOVING THE LINER FROM THE PATIENT REQUIRING THE SURGEON TO GET AN ADDITIONAL INSTRUMENT TO FIND AND RETRIEVE THE SCREW. ACTION TAKEN: OPEN THE SECOND SET OF TRIAL LINERS WHICH WERE AVAILABLE. NO DELAY TO PROCEDURE. NO AE TO PATIENT. MALE PATIENT INITIALS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7331348 ↗