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LFIT 06-4010Recalls & reported problems

Howmedica Osteonics Corp. · Femoral Head · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327032635), received between Jul 14, 2020 and Jul 14, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • Inflammation1
  • Injury1
  • Reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A POLY INSERT AND A C-TAPER FEMORAL HEAD "WERE EXPLANTED DURING A RIGHT HIP REVISION DUE TO ALTR." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Inflammation; Injury; Reaction

    MAUDE report 10269985 ↗

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.

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.