PINNACLE 2218-28-750Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295100676), received between Aug 4, 2020 and Sep 5, 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.

• MalfunctionSep 5, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS REPORTED AS BROKEN. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687213 ↗
• MalfunctionOct 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT LINER TRIAL C RING MISSING. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. HIP BALL TRIAL SCRATCHED, WORN. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. SET SCREW LOCKED. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551240 ↗
• MalfunctionAug 4, 2020Break; Break

  IT WAS REPORTED THAT AFTER PINNACLE CONSTRAINED LINER HAD BEEN RETURNED TO THE OFFICE, IT WAS DISCOVERED THAT THE TRIAL WAS BROKEN. THE INTERNAL THREADED METAL PIECE IS DISASSOCIATED FROM THE PLASTIC LINER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10362256 ↗