V40 Head 6260-9-432Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327013153), received between Apr 18, 2019 and Nov 20, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2024Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT ACETABULAR REVISION ON (B)(6) 2012 AND WAS IMPLANTED WITH AN LFIT V40 COCR FEMORAL HEAD AND COMPETITOR ACETABULAR SYSTEM. HE WAS REVISED ON (B)(6) 2021 WITH A PRE AND POST OPERATIVE DIAGNOSIS OF "MECHANICAL COMPLICATION RIGHT HIP STATUS POST RIGHT TOTAL HIP ARTHROPLASTY REVISION WITH ELEVATED COBALT AND CHROMIUM IONS AND LOOSE RIGHT FEMORAL STEM".

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 20741328 ↗
• InjuryMar 19, 2024Degraded; Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated; Degraded; Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "THE PATIENT REPORTED PAIN AND DISCOMFORT IN HER LEFT HIP, X-RAYS SHOWED A SIZE 1 ACCOLADE TMZF STEM WITH A 32+12 V40 FEMORAL HEAD DISASSOCIATED FROM THE TRUNNION, SHE WAS BROUGHT TO THE OPERATING ROOM FOR A REVISION SURGERY, THE FEMORAL HEAD WAS FOUND TO BE DISASSOCIATED FROM THE STEM, THERE WAS DAMAGE TO SOME OF THE SOFT TISSUES AND METALLOSIS FINDINGS, A FEMORAL REVISION WAS PERFORMED UTILIZING ANOTHER COMPANY¿S IMPLANT, THE ACETABULAR COMPONENT WAS STRYKER AND WAS RETAINED, A LINER EXCHANGE WAS PERFORMED ON THE TRIDENT ACETABULAR CUP, IT WAS A SIZE D ALPHA CODE. NO FURTHER INFORMATION IS AVAILABLE OR IMPLANTS DUE TO FACILITY POLICY. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Metal Related Pathology; Pain

  MAUDE report 18934728 ↗
• InjuryJan 31, 2020Material Erosion; Insufficient Device Problem Information; Material Erosion; 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 THE FEMORAL HEAD WAS EXPLANTED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT HE 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 HIS BLOOD. UPDATE PER OP REPORT: "THERE WAS A MASSIVE FLUID COLLECTION THAT WAS DARK RED/BROWN COLOR, WATERY IN CONSISTENCY. THIS WAS EVACUATED. THERE WERE MULTIPLE SOFT TISSUE NECROTIC MASSES THROUGHOUT THE JOINT. THE BIGGEST ONE MEASURED APPROXIMATELY 10CM X 6CM. THERE WERE MULTIPLE SMALLER ONES. REPRESENTATIVE TISSUE SAMPLES WERE SENT FOR FROZEN SECTIONS. THIS REVEALED NO EVIDENCE OF ACUTE INFLAMMATION. THE ENTIRE PERICAPSULAR TISSUE WAS NECROTIC. DEBRIDEMENT WAS QUITE EXTENSIVE, REQUIRING AN EXTENSIVE AMOUNT OF TIME TO FIND HEALTHY-APPEARING TISSUE."

  Patient problems: Fluid Discharge; Inflammation; Injury; Metal Related Pathology; Reaction; Swelling/ Edema

  MAUDE report 9652553 ↗
• InjuryDec 9, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  PRIMARY REVISION OF A RIGHT HIP. HEAD DISSOCIATED FROM THE STEM AND EXCESSIVE WEAR OF THE TRUNNION. THE PATIENT WAS REVISED TO A RESTORATION MODULAR SYSTEM AND A BIOLOX HEAD. THERE ARE NO ALLEGATIONS AGAINST THE LINER. IMAGES ARE PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 9437540 ↗
• InjuryApr 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT OF EXETER PROSTHESIS IS FRACTURED AT THE NECK. 2 ADDITIONAL OPERATIONS HAVE TAKEN PLACE. REVISION OPERATION IS PLANNED FOR (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 8528137 ↗