V40 Head 6260-9-122Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327013016), received between Sep 10, 2018 and Feb 12, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 15, 2021Open, Classified

   There is a potential for the outer white Tyvek lid to debond from the sealed package.

   Z-0314-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2024Degraded; Degraded

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017. IT IS ALLEGED THAT SHE BEGAN EXPERIENCING SEVERE HIP PAIN, BURNING PAIN WHEN SITTING AND SLEEPING, ALONG WITH CLICKING IN THE LEFT HIP. RADIOGRAPHS SHOWED ASEPTIC LOOSENING OF THE LEFT FEMORAL COMPONENT. WORKUPS COMPLETED REVEALED ELEVATED METAL LEVELS (ESR 38, CRP 19, COBALT AND CHROMIUM <1.0) AND A LEFT HIP ASPIRATION SHOWED THE GROWTH OF STAPH HOMINIS. ALLEGEDLY AS METALLOSIS WAS SUSPECTED, SHE UNDERWENT A LEFT TOTAL HIP REVISION ON (B)(6) 2020.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Metal Related Pathology; Pain; Unspecified Infection

  MAUDE report 18683764 ↗
• InjuryFeb 8, 2024Degraded; Degraded

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2016. IT IS ALLEGED THAT SHE BEGAN EXPERIENCING SEVERE HIP PAIN, BURNING PAIN WHEN SITTING AND SLEEPING. SHE WAS REVISED ON (B)(6) 2020 ALLEGEDLY SECONDARY TO METALLOSIS AND WORKUPS COMPLETED REVEALED ELEVATED METAL LEVELS (ESR 38, CRP 19, COBALT AND CHROMIUM <1.0).

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 18673473 ↗
• InjuryFeb 28, 2023Material Erosion; Material Erosion

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT WITH STRYKER COMPONENTS. IT IS FURTHER ALLEGED THAT THREE MONTHS AFTER THE RIGHT HIP REPLACEMENT, THE PLAINTIFF BEGAN TO EXPERIENCE CLICKING OF THE JOINT, ALONG WITH PAIN IN HER HIP, GROIN AND BUTTOCK AREA. BLOOD TEST REVEALED ELEVATED CHROMIUM (1.0) AND COBALT (7.3) LEVELS AS WELL AS ELEVATED ESR (9) AND CRP (2.8) LEVELS. ALLEGEDLY THE PATIENT WAS REVISED ON AN UNKNOWN DATE.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 16452309 ↗
• InjuryDec 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REQUIRED REVISION OF HER CONSTRAINED ALL POLY CUP, AS THE BIPOLAR SECTION OF THE PROSTHESIS DISLOCATED OUT OF THE POLY OUTER SECTION. THIS OCCURRED APPARENTLY AS THE PATIENT ROSE FROM SITTING TO STANDING FROM A COUCH. THE OUTER PART OF THE CONSTRAINED CUP WAS REAMED OUT OF THE ACETABULUM, THEREFORE DESTROYED DURING REMOVAL. THE ORIGINAL SURGERY WAS REVISION OF A FAILED FEMORAL NAIL.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9476947 ↗
• InjuryOct 15, 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) 2016 AND WAS REVISED ON (B)(6) 2017. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICES AT ISSUE AND DEVICE RECALL.

  Patient problems: Injury; Metal Related Pathology

  MAUDE report 9192592 ↗
• InjuryMay 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "CUP, HEAD, LINERS REMOVED DUE TO METALLOSIS CAUSED BY MALPOSITIONED IMPLANTS RESULTING IN IMPINGEMENT".

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8627367 ↗
• InjuryFeb 25, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED 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 (B)(6) 2018. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 8367157 ↗
• InjuryOct 18, 2018Degraded; Insufficient Device Problem Information; Degraded; 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) 2011 AND WAS REVISED ON (B)(6) 2014. 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 COBALT AND CHROMIUM IN HER BLOOD.

  Patient problems: Foreign Body Reaction; Inflammation; Metal Related Pathology; Pain; Reaction

  MAUDE report 7977985 ↗
• InjuryOct 11, 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 HER LEFT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED (B)(6) 2017. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE AND EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HER BLOOD.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 7957222 ↗
• InjurySep 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "ELEVATED COBALT METAL LEVELS". SPOKE TO REP. PATIENT WAS REVISED.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 7861449 ↗