V40 Head 6260-9-428Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327013146), received between Jul 2, 2019 and Jul 25, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO A MASS OF TISSUE CAUSING NERVE IMPINGEMENT CONCERNS. SURGEON ALSO DETERMINED THAT THE OFFSET OF THE IMPLANTED HEAD WAS TOO GREAT. AN I&D WAS PERFORMED AND A CONSTRAINED LINER AND 28 +12 FEMORAL HEAD WERE REVISED TO ANOTHER CONSTRAINED LINER AND 28 +8 HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 17387106 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. INTRA-OPERATIVELY, IT WAS DISCOVERED THAT THE ADM/ MDM POLY LINER WAS BROKEN IN HALF, AND THE SURGEON REPORTED THAT THE LINER WAS WORN WHERE THE COLLAR OF THE METAL FEMORAL HEAD WAS ARTICULATING WITH THE POLY. A METAL MDM LINER, POLY ADM/ MDM INSERT, AND METAL FEMORAL HEAD WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 12757476 ↗
• InjuryJul 2, 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 HER RIGHT HIP ON OR ABOUT (B)(6) 2010 AND WAS REVISED ON (B)(6) 2017. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

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

  MAUDE report 8752694 ↗