V40 Head 6260-5-026Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327012828), received between Oct 3, 2018 and Jul 13, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2021Fitting Problem; Fitting Problem

  METAL HEAD 26MM/±0MM WAS ATTACHED TO THE NECK OF AN ACCOLADE II 132 DEGREE #4 WITH A HEAD IMPACTOR AND HAMMER. DURING REDUCTION WITH A CENTRAX 46MM HEAD, THE CONNECTION BETWEEN THE NECK AND THE HEAD WAS TOO LOOSE AND IT FELL OUT IMMEDIATELY. WHEN SURGEON REMOVED THE HEAD AND PUT THE HEAD TRIAL ON THE STEM NECK, IT FIT FINE. THE DOCTOR'S OPINION WAS THAT THE INNER DIAMETER OF THE METAL HEAD WAS TOO LARGE. AS A SUBSTITUTE, METAL HEAD 26MM±0 AND CENTRAX 48MM WERE USED. LEG LENGTH INCREASED BY 3 MM PLEASE INVESTIGATE WHETHER THE INNER DIAMETER OF THE METAL HEAD IS DIFFERENT FROM THE NORMAL V40.

  Patient problems: Unequal Limb Length

  MAUDE report 12157297 ↗
• MalfunctionApr 16, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AFTER THE HEAD IS ATTACHED, THE HEAD COME OFF FROM THE STEM DURING BIPOLAR MOUNTING. BIPOLAR LOCKING IS ALSO HALF LOCKING, AND THERE IS A DOUBT THAT THE HEAD IS NOT FITTED PROPERLY, ANOTHER HEAD USED AND CONTINUING THE OPERATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8518010 ↗
• MalfunctionDec 20, 2018Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A BHA, A V40 HEAD COULD NOT SLIDE SMOOTHLY IN THE CENTRAX (41 MM). ANOTHER CENTRAX (42 MM) WAS USED INSTEAD WITHOUT ANY REPORTED PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8183374 ↗
• InjuryOct 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2016. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL, EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HIS BLOOD.

  Patient problems: Injury; Reaction

  MAUDE report 7931795 ↗