LFIT 06-4405Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327032673), received between Sep 3, 2019 and Sep 3, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• InjurySep 3, 2019Mechanical Problem; Mechanical Problem

  AS REPORTED: "PROCEDURE: LEFT HIP REVISION. PRE-OP DIAGNOSIS: MECHANICAL LOOSENING OF LEFT HIP. PER SURGEON. STEM WAS WELL FIXED. WENT TO 44 +10 HEAD FOR STABILITY. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL". A 44 +5 COCR HEAD AND 44H POLY LINER WERE REVISED TO A 44+10 COCR HEAD AND ANOTHER 44H POLY LINER. REP PROVIDED A PRE-REVISION X-RAY, REVISION IMPLANT STICKERS, AND PICTURES OF THE EXPLANTS.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8958531 ↗

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