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V40 Head 6260-5-328Recalls & reported problems

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

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327012927), received between Aug 29, 2018 and Jun 6, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (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

  • Degraded2
  • Device Dislodged or Dislocated1
  • Insufficient Device Problem Information1

Patient problems

  • Injury2
  • Joint Dislocation2
  • Foreign Body Reaction1
  • Inflammation1
  • Metal Related Pathology1
  • Reaction1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 6, 2023Degraded; Degraded

    AS REPORTED: "DR. PERFORMED A RIGHT HIP REV DUE TO ALTR." A HEAD, LINER, AND SHELL WERE REVISED.

    Patient problems: Foreign Body Reaction

    MAUDE report 17076214 ↗
  • InjurySep 17, 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 AND LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2008 AND WAS REVISED ON (B)(6) 2011. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

    Patient problems: Inflammation; Injury; Joint Dislocation; Metal Related Pathology; Reaction

    MAUDE report 9075197 ↗
  • InjuryAug 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO MULTIPLE DISLOCATIONS AND INSTABILITY. INTRA-OPERATIVELY, SEVERE POLY WEAR WAS NOTED. PATIENT WAS REVISED TO AN ADM/MDM LINER CONSTRUCT WITH A NEW SHELL AND HEAD.

    Patient problems: Injury; Joint Dislocation

    MAUDE report 7828606 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish devices →

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