LFIT 06-3625Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327032796), received between Aug 15, 2018 and Jun 29, 2020 — classified as 3 injuries.

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

• InjuryJun 29, 2020Material Erosion; Loss of Osseointegration; Material Erosion; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNIONOSIS AND SHELL LOOSENING. INTRA-OPERATIVELY, BLACK MATERIAL INSIDE THE FEMORAL HEAD AND PSEUDOTUMOR WERE NOTED. THE PATIENT'S SHELL, LINER, AND FEMORAL HEAD WERE REVISED TO A NEW STRYKER SHELL, LINER, AND CERAMIC HEAD WITH SLEEVE. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP ALSO CONFIRMED THE FEMORAL HEAD WILL BE RETURNED. THE SURGEON IS REQUESTING INVESTIGATION RESULTS FOR THE FEMORAL HEAD.

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 10206167 ↗
• InjuryOct 4, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2012. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. PATIENT HAS NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE FEMORAL HEAD AT ISSUE.

  Patient problems: Inflammation; Metal Related Pathology; Reaction

  MAUDE report 9156022 ↗
• InjuryAug 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ACETABULAR COMPONENT. UPDATE 20/JUL/2018: AS REPORTED BY REP: PATIENT HAD A PAINFUL HIP FOR YEARS. SURGEON WOULD LIKE THE HEAD CHECKED FOR WEAR. HEAD, LINER, AND SHELL WERE REVISED.

  Patient problems: Injury; Pain

  MAUDE report 7785652 ↗

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.