V40 Head 6260-5-132Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327012873), received between Apr 3, 2017 and Oct 18, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Corroded” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2022Corroded; Corroded

  IT WAS REPORTED THAT FOLLOWING DETECTION OF A HIGH LEVEL OF IONS METAL IN PATIENT BLOOD WITH LUMP IT WAS DISCOVERED THERE WAS TRUNNIONOSIS ON THE ACCOLADE 2 WITH 32MM METAL HEAD. REVISION CASE: REMOVED FEMORAL HEAD, IMPLANTED TITANIUM SLEEVE +4MM WITH UNIVERSAL BIOLOX 32MM HEAD. BLACK CORROSION WAS VISIBLE ON ACCOLADE 2 TRUNNION AND INSIDE THE 32MM METAL HEAD.

  Patient problems: Metal Related Pathology

  MAUDE report 15621358 ↗
• InjuryAug 3, 2022Degraded; Degraded

  "TRUNNIONOSIS STEM BRACE 2 AND METAL HEAD 32MM +4MM."

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology

  MAUDE report 15154585 ↗
• InjuryJul 18, 2022Degraded; Degraded

  PATIENT'S DAUGHTER STATED HER FATHER HAD A RIGHT THA AND FELT A DISCOMFORT ON HIS HIP. PATIENT FELT EXTREME PAIN WHEN HE TRIED WALKING AND WHEN TRYING TO EXTEND HIS LEG. PATIENT WAS BROUGHT TO THE ER AND GIVEN MRI, X-RAY IMAGES, CT SCAN WHICH CONFIRMED AN INFECTION. WHILE AT THE ER, THE SURGEON DRAINED SOME INFECTION TO ALLEVIATE THE PAIN THE PATIENT WAS EXPERIENCING. THEY PERFORMED AN I&D BUT THE PATIENT WAS NOT REVISED DUE TO HIS AGE AND BONE LOSS. PATIENT WAS TOLD THAT HIS IMPLANTS ARE PART OF A RECALL WHILE AT THE HOSPITAL. PATIENT WOULD LIKE TO CONFIRM IF HIS IMPLANTS ARE PART OF A RECALL AS HE WAS NEVER NOTIFIED OF THE RECALL. THE OPERATION ALSO REVEALED MILD TRUNNIONOSIS.

  Patient problems: Bacterial Infection; Pain

  MAUDE report 15046010 ↗
• InjuryMar 16, 2022Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2017 AND WAS REVISED ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 13790627 ↗
• InjuryJun 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REMOVAL OF COCR HEAD AND POLYETHYLENE INSERT AND REPLACEMENT WITH NEW INSERT AND BIOLOX CERAMIC HEAD WITH V40 SLEEVE. UPDATE 10/MAY/2019 (B)(6): AS REPORTED IN ADVERSE CONSEQUENCES DETAILS: ELEVATED COCR LEVELS IN PATIENT.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8671709 ↗
• InjuryApr 3, 2017Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON, WAS ATTEMPTING TO IMPACT A V40 COCR SIZE 32MM +0 FEMORAL HEAD ONTO A SIZE 7-132° ACCOLADE 2 STEM. UPON IMPACT IT DID NOT WELD ONTO THE STEM TRUNION. HE CLEANED THE FEMORAL HEAD AND ATTEMPTED TO IMPACT AGAIN WITH THE SAME RESULT. WE BROUGHT IN ANOTHER FEMORAL HEAD OF THE SAME SIZE AND IT WORKED FINE UPON IMPACT. IT WAS REPORTED THAT A SURGICAL DELAY OF LESS THAN 10 MINUTES WAS NOTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6455381 ↗