LFIT 06-3697Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327032819), received between Dec 18, 2018 and Dec 18, 2018 — classified as 1 injury.

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

• InjuryDec 18, 2018Unstable; Unstable

  PATIENTS FRIEND CALLED AND STATED THAT THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2014. SHE STATED THAT PATIENT WAS IN PAIN SINCE DAY ONE POSTOP. PATIENT EXPERIENCED PAIN, LIMITED RANGE OF MOTION, WOULD HEAR NOISES PERIODICALLY AND CANT WALK WELL. PATIENT HAD A REVISION ON (B)(6) 2014.

  Patient problems: Ambulation or Postural Difficulties; Injury; Loss of Range of Motion; Pain

  MAUDE report 8175452 ↗

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.