PINNACLE 2218-28-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295100225), received between Apr 18, 2022 and Apr 18, 2022 — 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.

• MalfunctionApr 18, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT AN INITIAL THA SURGERY. AFTER SURGERY, THE PATIENT UNDERWENT A REVISION THA SURGERY ON (B)(6), 2022, FOR UNKNOWN REASON. IN THE REVISION, THE EDGE OF THE LINER CHIPPED SLIGHTLY DURING INSERTION. THE CHIPPED PIECE OF THE LINER WAS REMOVED FROM THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. BUT AFTER THE REVISION, THERE WAS A REQUEST FROM THE HOSPITAL TO OBTAIN AN INVESTIGATION FORM TO VERIFY WHETHER THE CHIPPED PIECE OF THE LINER WAS COMPLETELY IDENTICAL TO THE LINER ITSELF AND WHETHER THERE WERE ANY CHIPPED PIECES OF THE LINER REMAINING IN THE BODY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137684 ↗