V40 Head 6260-9-322Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327013092), received between Jun 13, 2019 and Oct 6, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Corroded” (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.

• InjuryOct 6, 2022Mechanical Problem; Mechanical Problem

  THIS PI IS FOR REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2022. WHILE PROVIDING INFORMATION FOR REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2022, REP PROVIDED A USAGE SHEET FROM A PRIOR REVISION ON (B)(6) 2022. REPORTING REP WAS NOT PRESENT FOR THE PROCEDURE, BUT A STRYKER REP WAS PRESENT. PATIENT WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER FROM THE SHELL. SURGEON DECIDED THAT THE PATIENT DID NOT HAVE ENOUGH OFFSET. A RESTORATION MODULAR PROXIMAL BODY (IMPLANTED (B)(6) 2020), AND A CONSTRAINED LINER AND FEMORAL HEAD (IMPLANTED (B)(6) 2021) WERE REVISED. THE SHELL (IMPLANTED (B)(6) 2020) WAS NOT REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15550341 ↗
• InjuryJul 6, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  A THIRD REVISION OF THIS PATIENT THAT IS MENTALLY AND PHYSICALLY CHALLENGED, AS IT HAS DISLOCATED AGAIN USING AN EXETER STEM AND HEAD. UPDATE 16 JUNE 2021: REP CONFIRMED THAT THIS WAS THE PATIENTS 2ND REVISION, BUT THIRD CASE.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 12125689 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; 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 HER RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON OR ABOUT (B)(6) 2019. 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 9437539 ↗
• InjuryJun 13, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED. AS REPORTED BY REP: "ELEVATED COBALT LEVELS. [REVISION] SHOWED TAPER CORROSION".

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8697498 ↗