PINNACLE 2218-28-650Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295100652), received between Aug 15, 2017 and Jul 25, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE METAL RING CAME OFF THE TRIAL AND THE METAL SCREW IN PORTION WOULD NOT STAY IN THE TRIAL. ALL PIECES WERE RETRIEVED. SURGICAL DELAY IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390412 ↗
• MalfunctionMar 28, 2022Break; Break

  THE TRIAL LINER BROKE WHEN TRIALING THE HIP, THE PATIENT CAME TO NO HARM AND THE SURGERY TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13930663 ↗
• MalfunctionAug 15, 2017Break; Break

  IT WAS REPORTED THAT UPON POST SURGICAL EXAMINATION, BOTH CUPS WERE FOUND TO HAVE DEEP ROUGH GAUGES ON THE INSIDE AND BOTTOM SURFACE OF THE LINERS. SOME OF THE GAUGE CONTINUE TO THE EXTERIOR OF THE CUP AS WELL.

  Patient problems: No Information

  MAUDE report 6795660 ↗