LFIT 6260-9-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327032710), received between Jul 26, 2018 and Oct 28, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Degraded” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO METALLOSIS. INTRA-OPERATIVELY, IT WAS CONFIRMED THE PATIENT HAD BLACK TISSUE, AND THE STEM WAS OBSERVED TO HAVE SLIGHT WEAR. THE HEAD AND LINER WERE REVISED TO A CERAMIC HEAD WITH SLEEVE AND NEW LINER. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction

  MAUDE report 20550808 ↗
• InjuryNov 2, 2023Degraded; Degraded

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6), 2009, AND WAS IMPLANTED WITH A ACCOLADE TMZF HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD. HE WAS REVISED ON (B)(6), 2021, ALLEGEDLY DUE TO TRUNNIONOSIS.

  Patient problems: Metal Related Pathology

  MAUDE report 18054064 ↗
• InjuryMay 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO EXCESSIVE TRUNNION WEAR AND HEAD DISSOCIATION. THE STEM, HEAD AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, ADM/ MDM POLY INSERT, AND MDM METAL LINER. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16859102 ↗
• InjuryFeb 7, 2023Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component

  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 RIGHT HIP ON OR ABOUT (B)(6) 2013 AND WAS REVISED ON (B)(6) 2021. 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.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 16315830 ↗
• InjuryOct 18, 2022Degraded; Material Erosion; Degraded; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNION WEAR AND METALLOSIS. INTRA-OPERATIVELY, LINER WEAR WAS ALSO NOTED. THE STEM, HEAD, AND LINER WERE REVISED.

  Patient problems: Metal Related Pathology

  MAUDE report 15627992 ↗
• InjuryJul 28, 2022Material Erosion; Material Erosion

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON (B)(6) 2013. IT IS FURTHER ALLEGED THAT HE SUFFERED PROGRESSIVE GROIN AND LEFT HIP PAIN, ELEVATED COBALT LEVEL AT 4.3 AND ON (B)(6) 2020 UNDERWENT REVISION SURGERY OF THE ACETABULAR LINER AND FEMORAL HEAD.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 15122263 ↗
• InjuryFeb 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISION OF ACCOLADE I STEM.

  Patient problems: Foreign Body Reaction

  MAUDE report 11278248 ↗
• InjuryDec 15, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT'S ALLEGED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY IN 2007 WHERE HE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. IT IS FURTHER ALLEGED THAT THE PATIENT BEGAN TO EXPERIENCE PAIN AND CLICKING WITH MOVEMENT. X-RAYS PERFORMED ON (B)(6) 2019 REVEALED SEVERE TRUNNION FAILURE. BLOOD WORK ALSO REVEALED ELEVATED LEVELS OF COBALT. THIS RESULTED IN THE PATIENT TO UNDERGO RIGHT HIP REVISION SURGERY ON (B)(6) 2020.

  Patient problems: Discomfort; Metal Related Pathology; Pain

  MAUDE report 11011127 ↗
• InjuryFeb 11, 2020Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  PATIENT CALLED STATING HE HAD A RIGHT HIP REPLACEMENT DONE ON (B)(6) 2008 AND IS EXPERIENCING PAIN AS HE WALKS. PATIENT ALSO REPORTED THAT HIS DOCTOR MENTIONED BONE LOSS AND LOOSENING IN HIS HIP. PATIENT WOULD LIKE TO KNOW IF HIS IMPLANTS WERE PART OF A RECALL.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Inadequate Osseointegration; Osteolysis; Pain

  MAUDE report 9693273 ↗
• InjuryOct 16, 2019Degraded; Degraded

  THE CUSTOMER REPORTED THAT THE TMZF STEM HAD MAJOR TRUNNIONOSIS AND THE PATIENT REQUIRED REVISION SURGERY.

  Patient problems: Injury

  MAUDE report 9197367 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT UNDERWENT LEFT HIP REVISION SURGERY TO REPLACE IMPLANTED LFIT V40 44MM/-4 FEMORAL HEAD AND 44G X3 NEUTRAL ACETABULAR LINER. SURGEON CLAIMS TRUNNION AND INSIDE OF EXPLANTED FEMORAL HEAD CONTAINED NOTICEABLE BLACK DEBRIS FOLLOWING EXPLANT. SURGEON DOES NOT HAVE CONCERNS ABOUT THE FUNCTIONALITY OF THE LINER."

  Patient problems: Injury; Reaction

  MAUDE report 8864284 ↗
• InjuryMay 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE TRUNNION OF THE STEM BREAKING OFF, DISCONNECTING THE STEM FROM THE HEAD. INTRA-OPERATIVELY, A LITTLE BLACK TISSUE WAS NOTED IN THE PATIENT ALONG WITH DAMAGE TO THE POLY LINER. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A CERAMIC HEAD. REP PROVIDED A PRIMARY OPERATIVE REPORT, PRE- REVISION X-RAYS, AND EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8628713 ↗
• InjuryMar 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED THAT HE HAD BEEN MADE AWARE OF A REVISION SURGERY OF AN ACCOLADE STEM.

  Patient problems: Injury

  MAUDE report 8404109 ↗
• InjuryJul 26, 2018Degraded; Device Dislodged or Dislocated; Material Deformation; Degraded; Device Dislodged or Dislocated; Material Deformation

  AS REPORTED: "YOU COULD SEE ON X-RAY WHERE THE TRUNNION WAS WORN OUT. WE TOOK THE STEM OUT AND WENT BACK WITH A RESTORATION MODULAR." REVIEW OF EXPLANT PHOTOS CONFIRM SIGNIFICANT TRUNNION WEAR THEREFORE CONFIRMING HEAD-STEM DISASSOCIATION

  Patient problems: Injury

  MAUDE report 7722202 ↗