PINNACLE 2218-90-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295102281), received between Apr 4, 2018 and Mar 16, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2023Break; Break

  IT WAS REPORTED THE INSTRUMENT WAS DEFECTIVE. THE TEETH ON WERE COMPLETELY GONE AND THEREFORE IT WASN'T POSSIBLE TO PLACE THE CERAMIC IMPLANT AS PER THE STANDARD PROCEDURE. SALES REP NOTICED THIS AT THE START OF THE PROCEDURE SO THE SURGEON COULD ANTICIPATE TO IT. THEY TOOK OUT THE LINER AGAIN TO MANUALLY POSITION BEFORE FIXATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555339 ↗
• MalfunctionMar 5, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN BY DOCTOR AND NO LONGER ATTACHES TO INSERTER HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9794331 ↗
• MalfunctionApr 4, 2018Break; Break

  TOTAL HIP REPLACEMENT, (B)(6) HOSPITAL, (B)(6) 2018. IMPLANT RETAINING CLIPS SNAPPED OFF DURING IMPLANTATION. ANOTHER TRAY OF INSTRUMENTS OPENED. TEN MINUTES DELAY IN SURGERY. NO AE TO PATIENT.

  Patient problems: Not Applicable

  MAUDE report 7395272 ↗