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V40 Head 6260-5-226Recalls & reported problems

Howmedica Osteonics Corp. · V40 Femoral Head · Class 2 · Implant

Adverse event reports
5
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327012880), received between Oct 31, 2018 and Dec 1, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 Information2
  • Device Difficult to Setup or Prepare1
  • Device Dislodged or Dislocated1
  • Material Discolored1
  • Use of Device Problem1

Patient problems

  • Insufficient Information3
  • Injury2
  • Joint Dislocation1
  • Unspecified Infection1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    ON (B)(6) 2022, 26MM INNER HEAD WAS ACCIDENTALLY USED INSTEAD OF 28MM. DUE TO THIS MISTAKE, DISLOCATION HAPPENED. REVISION WAS PERFORMED. LEFT HIP.

    Patient problems: Insufficient Information

    MAUDE report 15892253 ↗
  • InjuryDec 14, 2021Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

    AFTER BHA, DISTRIBUTER CHECKED THE SIZE AND FOUND A UHR WITH 28MM INNER DIAMETER WAS USED ON 26MM HEAD. SALES REP WAS NOT PRESENT. UPDATE 04-MAR-2022: PATIENT WAS REVISED ON (B)(6) 2021.

    Patient problems: Insufficient Information

    MAUDE report 13006693 ↗
  • MalfunctionMay 17, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

    AFTER INSERTING THE STEM INTO THE FEMUR AND FIRMLY DRIVING THE INNER HEAD REPORTED THIS TIME, SURGEON INSERTED A BIPOLAR CUP AND TRIED TO REDUCE IT. THEN, THE INNER HEAD WAS DISENGAGED FROM THE STEM ROLLED DOWN TO THE OUTSIDE.. SO THE HEAD BECAME DIRTY. THE BIPOLAR CUP AND INNER HEAD WERE RAISED ONE SIZE.

    Patient problems: Insufficient Information

    MAUDE report 11832625 ↗
  • InjuryMar 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    RIGHT BHA WAS PERFORMED ON (B)(6) 2017. DUE TO INFECTION, HEAD WAS REMOVED ON (B)(6) 2018.

    Patient problems: Injury; Unspecified Infection

    MAUDE report 9889607 ↗
  • InjuryOct 31, 2018Material Discolored; Material Discolored

    AS THE PATIENT WHO TOOK EFFECT AT THA ON (B)(6) 2003 REPEATED DISLOCATION, REPLACED ON THE CUP SIDE ON (B)(6) 2018. WHEN THE HEAD WAS PULLED OUT, THE TRUNNION INSERTION PART OF THE HEAD WAS DISCOLORED BLACK. REMAINED THE STEM AS IT WAS.

    Patient problems: Injury; Joint Dislocation

    MAUDE report 8026257 ↗

Other Prosthesis, hip, hemi-, femoral, metal devices

All Prosthesis, hip, hemi-, femoral, metal devices →

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