LFIT 06-3699Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327072389), received between Jul 3, 2020 and Jul 3, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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 16, 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.

• InjuryJul 3, 2020Material Erosion; Material Deformation; Unintended Movement; Material Erosion; Material Deformation; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SUBSIDENCE OF THE FEMORAL STEM AFTER A PATIENT FALL. SURGEON REPORTED THAT THE IMPLANTED STEM WAS TOO SMALL FOR THE PATIENT'S ANATOMY AND THAT THE FALL CONTRIBUTED TO SUBSIDENCE. DURING THE REVISION, PITTING WAS NOTED ON THE INNER ARTICULAR SURFACE OF THE POLY LINER. THE SURGEON REPORTED THIS WAS LIKELY CAUSED BY ABRASIVE MATERIAL ON THE FEMORAL HEAD, AND WOULD LIKE THE LINER TO BE INVESTIGATED TO CONFIRM, AND WOULD LIKE THE RESULTS. THE STEM, HEAD, AND LINER WERE REVISED. THE DEVICES ARE ALLEGEDLY AVAILABLE FOR RETURN. THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall; Injury; Pain

  MAUDE report 10229289 ↗