Conformis Hip System HAA050D00N01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M572HAA050D00N011), received between Mar 24, 2021 and Jul 23, 2021 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2021Mechanical Jam

  IT WAS REPORTED THAT THE TRIAL HEAD HAD STUCK ON THE IMPLANT DURING SURGERY. THE SURGEON UTILISED A BONE SCREW TO REMOVE THE TRIAL HEAD. THE SURGEON HAD TO UTILISE FORCE WITH A BONE TAMP AND MALLET TO RELEASE THE TRIAL HEAD. THERE WAS A MAJOR DELAY OF 20 MINUTES DURING THE OPERATION.

  Patient problems: Insufficient Information

  MAUDE report 12221227 ↗
• MalfunctionMar 24, 2021Break

  IT WAS REPORTED THAT THE CORDERA PLASTIC TRIAL NECK BROKE WHILE THE SURGEON TRIED TO DISLOCATE THE HIP. THERE WERE NO DELAYS IN SURGERY NOR WERE THERE ANY DELAYS IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566246 ↗