V40 Head 6260-5-228Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327012897), received between Dec 6, 2018 and Sep 23, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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.

• InjurySep 23, 2024Degraded; Degraded

  AS REPORTED BY THE REP: "IT WAS A COMBINATION OF AN ACCOLADE 1 STEM AND COCR +HEAD. IT LOOKS LIKE THE PATIENT IS POTENTIALLY LOOKING TO CHECK/PURSUE ANY INCOMPATIBILITY AS THEY EXPERIENCED METALLOSIS. I HAVE FORWARDED THE HIP COMPOSITION GUIDE. RIGHT HIP; EVENT WAS NOTICED VIA MRI DONE AT CLINIC WHICH SHOWED PSEUDOTUMOR AND ELEVATED METAL ION LEVELS. ELEVATED METAL ION LEVELS (BOTH COBALT AND CHROMIUM ELEVATED) POST PRIMARY SURGERY. DURING REVISION SURGERY, TRUNNIONOSIS WAS NOTED.".

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 20284818 ↗
• InjurySep 4, 2024Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  THE HIP JOINT DISLOCATED, AND A REVISION WAS NECESSARY. THE PATIENT HAD A UHR HEAD AND AN ACCOLADE II STEM. INTRAOPERATIVELY, IT TURNED OUT THAT THE HEAD WAS NOT HELD ON THE STEM, AND THE OPERATOR REMOVED THE HEAD FROM THE STEM CONE WITHOUT ANY RESISTANCE. AFTER REMOVING THE HEAD AND STEM, STIMULAN WAS USED BECAUSE THE PATIENT HAD AN INFECTION.

  Patient problems: Inadequate Osseointegration; Joint Dislocation; Periprosthetic fracture; Unspecified Infection

  MAUDE report 20140626 ↗
• InjuryAug 2, 2022Corroded; Material Erosion; Corroded; Material Erosion

  IT HAS BEEN REPORTED "A REVISION SURGERY WAS REQUIRED DUE TO "RAISED METAL ION LEVELS". SURGEON REPORTED SIGNS OF METALLOSIS AT THE FEMORAL HEAD/TAPER IMPLANT JUNCTION. THE SURGEON DECIDED THE BEST THING FOR THE PATIENT WAS TO REMOVE THE MILLED BODY AND REPLACE IT WITH THE SAME SIZED ONE AND PUT A CERAMIC HEAD ON".

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 15154200 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2019 THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH AN ACCOLADE II 127° NECK ANGLE HIP STEM AND A V40 FEMORAL HEAD WHICH RESULTED IN REVISION AND PERSONAL INJURIES. UPDATE: PER LEGAL, "THE ALLEGATIONS ARE FOR THE ACCOLADE II STEM AND THE V40 HEAD. CURRENTLY WE DO NOT KNOW WHY THE PATIENT WAS REVISED OR WHAT DEVICES WERE EXPLANTED."

  Patient problems: Insufficient Information

  MAUDE report 12030829 ↗
• InjuryJan 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PHARMACIST FROM THE HOSPITAL REPORTED THE FOLLOWING EVENT: " INVOLVEMENT OF THE MEDICAL DEVICE IN THE OCCURRENCE OF METALLOSIS: CHROME-COBALT POISONING WITH CARDIOPATHY ON PROSTHESIS PLACED IN 2014. "

  Patient problems: Inflammation; Reaction

  MAUDE report 8273819 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO METALLOSIS AFTER PATIENT COMPLAINT OF PAIN AND DIFFICULTY AMBULATING. A 28 +4 HEAD AND 28 10° E LINER WERE REVISED TO A 32 0° LINER AND CERAMIC HEAD WITH SLEEVE. A RESTORATION PS STEM AND TRIDENT PSL CLUSTER SHELL WERE NOT REVISED.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Pain; Reaction

  MAUDE report 8137848 ↗