LFIT 06-4075Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327032659), received between May 19, 2021 and May 19, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Corroded” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K061434); they may or may not involve this specific model.

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.

• InjuryMay 19, 2021Corroded; Material Erosion; Corroded; Material Erosion

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT C-TAPER FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2013 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT HE BEGAN EXPERIENCING SIGNIFICANT PAIN IN HIS HIP IN 2018, MRI DEMONSTRATED "VERY LARGE JOINT INFUSION WITH PROGRESSIVE OSTEOLYTIC CHANGES" AND "LABORATORY RESULTS SHOWED ELEVATED COBALT LEVELS IN HIS BLOOD AS 17.7 MCG/L AND HIS CHROMIUM AS 3.5 MCG/L". IT IS ALLEGED THAT DURING THE REVISION SURGERY ON (B)(6) 2018 THE SURGEON NOTED SIGNS OF FRETTING AND CORROSION AT THE NECK AND REVISED THE ACETABULAR LINER AND THE FEMORAL HEAD.

  Patient problems: Metal Related Pathology

  MAUDE report 11847453 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061434. One submission often covers many models, so check the product and lot details in each record.

• Z-0390-2010 · Sep 4, 2009 · Terminated
  Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.
• Z-0391-2010 · Sep 4, 2009 · Terminated
  Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.