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Orthinox 6364-2-128Recalls & reported problems

Howmedica Osteonics Corp. · V40 FEM 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 04546540273321), received between Oct 21, 2022 and Oct 21, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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

  • Inadequacy of Device Shape and/or Size1
  • Use of Device Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryOct 21, 2022Inadequacy of Device Shape and/or Size; Use of Device Problem; Inadequacy of Device Shape and/or Size; Use of Device Problem

    TOTAL HIP SURGERY: SURGEON TRIALED SIZE 28MM HEAD, I RETRIEVED SIZE 28MM HEAD. HAD IMPLANT CHECKED BY SURGEON AND SCRUB NURSE. HANDED OVER TO SCOUT NURSE TO OPEN. NOTIFIED BY COLLEAGUE THAT 28MM HEAD WAS USED IN 32MM LINER. COLLEAGUE INFORMED TEAM AT HOSPITAL. THE PATIENT WAS TAKEN BACK INTO SURGERY TO CORRECT THE HEAD COMPONENT ON THE SAME DAY (B)(6) 2022.

    Patient problems: Insufficient Information

    MAUDE report 15648775 ↗

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.