LFIT 6260-9-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 07613327032703), received between Jun 26, 2018 and May 6, 2025 — classified as 39 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE IS AN UPCOMING ACCOLADE REVISION SURGERY. PATIENT NEEDED A REVISION SURGERY TO REPLACE THE STEM AND HEAD.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 21971608 ↗
• InjuryOct 23, 2024Corroded; Degraded; Corroded; Degraded

  IT WAS REPORTED BY COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2016, AND WAS IMPLANTED WITH AN LFIT COCR FEMORAL HEAD. HE WAS REVISED ON (B)(6) 2024, DUE TO ALLEGED PERSISTENT PAIN, ELEVATED METAL ION LEVELS AND CORROSION.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 20514258 ↗
• InjuryJul 1, 2024Corroded; Material Erosion; Corroded; Material Erosion

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON (B)(6) 2007 AND WAS REVISED ON (B)(6) 2019 DUE TO PAINFUL RIGHT TOTAL HIP ARTHROPLASTY, CORROSION AT THE HEAD/NECK JUNCTION WITH ADVERSE LOCAL TISSUE REACTION, AND DEVICE RECALL.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 19643375 ↗
• InjuryJun 9, 2024Degraded; Degraded

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT THAT ON (B)(6) 2009, AND WAS IMPLANTED WITH AN LIFT V40 COCR FEMORAL HEAD AND ACCOLADE TMZF HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED ACUTE ONSET OF PAIN. REVISION OPERATIVE REPORT STATES "THE TRUNNION HAD BEEN COMPLETELY WORN DOWN TO A POINT AND THERE WAS A LOOSE METAL FRAGMENT ALSO IN THE ACETABULUM."

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19495761 ↗
• InjuryMay 18, 2024Material Erosion; Patient Device Interaction Problem; Material Erosion; Patient Device Interaction Problem

  POST THA SURGERY, THERE WAS A FINDING OF BONE ATROPHY IN THE ANTERIOR OF THE ACETABULUM, AND ARMD (ADVERSE REACTION TO METAL DEBRIS) WAS SUSPECTED.

  Patient problems: Cyst(s); Metal Related Pathology

  MAUDE report 19348334 ↗
• InjuryApr 15, 2024Fracture; Fracture

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2012 AND WAS IMPLANTED WITH A LFIT V40 FEMORAL HEAD AND ACCOLADE HIP STEM. HE WAS REVISED ON (B)(6) 2021 DUE TO ALLEGED STEM FRACTURE AND METALLOSIS.

  Patient problems: Foreign Body Reaction

  MAUDE report 19104331 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II STEM. HE UNDERWENT REVISION SURGERY ON JANUARY 5, 2022, DUE TO ALLEGED ADVERSE LOCAL TISSUE REACTION.

  Patient problems: Foreign Body Reaction

  MAUDE report 18928225 ↗
• InjuryMar 19, 2024Material Erosion; Material Erosion

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE UNDERWENT REQUIRED REVISION SURGERY ON (B)(6) 2021, DUE TO ALLEGED LEFT HIP PAIN AND TRUNNIONOSIS.

  Patient problems: Pain

  MAUDE report 18927851 ↗
• InjuryJun 6, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  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) 2021. 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: Foreign Body Reaction; Metal Related Pathology; Muscle/Tendon Damage; Osteolysis; Pain

  MAUDE report 17076241 ↗
• InjurySep 18, 2022Degraded; Material Erosion; Degraded; Material Erosion

  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) 2022. 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 15443351 ↗
• InjuryJun 3, 2022Degraded; Degraded

  IT WAS REPORTED BY PATIENT'S COUNSEL THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2015. IT IS FURTHER ALLEGED THAT HE HAD RECURRENT HIP EFFUSIONS AND HIS MRI WAS CONSISTENT WITH ADVERSE LOCAL TISSUE REACTION. HE WAS REVISED ON (B)(6) 2022 ALLEGEDLY DUE TO TRUNNIONOSIS.

  Patient problems: Foreign Body Reaction

  MAUDE report 14590544 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO ELEVATED CHROMIUM LEVELS (REPORTED TO THE REP AS "80"). AN ACCOLADE STEM, V40 COCR L-FIT HEAD, AND LINER WERE REVISED WITH NO ALLEGATIONS AGAINST THE LINER. REP REPORTED THAT PICTURES ARE AVAILABLE, BUT OTHERWISE NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12127255 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALL DEVICE WERE REMOVED DUE TO ARMD. PLEASE INVESTIGATE TRUNNION. AFTER SCREW WAS REMOVED, TRIDENT SHELL COULD BE REMOVED MANUALLY. PLEASE INVESTIGATE IF IN-GROWTH AND ON-GROWTH WAS ADVANCED AND IF THERE WAS ANY DEVICE ISSUE. SURGEON WOULD LIKE TO KNOW IF THIS DEVICE WAS SUBJECT TO RECALL.

  Patient problems: Foreign Body Reaction

  MAUDE report 11640686 ↗
• InjuryDec 11, 2020Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  AS REPORTED: "REVISION OF LEFT HIP DUE TO FRACTURED FEMORAL STEM AT HEAD NECK JUNCTION OF TRUNNION. NO TRAUMA/COMPLICATIONS DURING SURGERY FOR PATIENT." REP PROVIDED AN X-RAY, EXPLANT PICTURES, AND INTRA-OP PHOTOS OF BLACK TISSUE BOTH INSIDE AND REMOVED FROM PATIENT. THE STEM, HEAD, AND POLY INSERT WERE REVISED.

  Patient problems: Foreign Body Reaction; No Information

  MAUDE report 10992525 ↗
• InjuryJul 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE PRESENCE OF A REJUVENATE MODULAR STEM CONSTRUCT. INTRA-OPERATIVELY, METALLOSIS WAS NOTED AT THE HEAD/ NECK INTERFACE. THE STEM CONSTRUCT, LFIT V40 HEAD, AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED POLY LINER. REP CONFIRMED THAT HE HAS PICTURES RELATING TO THE EVENT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 10288211 ↗
• InjuryJul 1, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Degraded; 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 HIS RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2017. 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; Inflammation; Injury; Metal Related Pathology; Necrosis; Reaction

  MAUDE report 10216810 ↗
• InjuryJun 12, 2020Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  THIS PI IS FOR REVISION OF RIGHT HIP. 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) 2008 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. THE REVISION OPERATIVE REPORT NOTES "NOT A WHOLE LOT OF PAIN BUT HE WAS HAVING RATTLING AROUND AND INSTABILITY OF THE RIGHT HIP". INTRAOPERATIVELY IT WAS NOTED THAT "THE BALL WAS COMPLETELY SEPARATED AND LOOSE FROM THE TRUNNION".

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 10147589 ↗
• InjuryJan 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH A MEDWATCH REPORT (MW5087699) "REQUIRED HIP REPLACEMENT. DOCTOR INSTALLED A STRYKER ACCOLADE FEMORAL COMPONENT. I REQUIRE THREE MORE SURGERIES INCLUDING TWO HIP REPLACEMENTS. FIVE PLUS YEARS OF PAIN." SPOKE TO PATIENT: PATIENT STATED HE IS NOT SURE IF HE WAS REVISED TO STRYKER DEVICES. UPDATE 13-DEC-2019: AS PER OPT REPORT RECEIVED, THE PATIENT WAS IMPLANTED ON (B)(6) 2014 AND REVISED ON (B)(6) 2018 DUE TO METALLOSIS/TRUNNIONOSIS. THE FEMORAL HEAD REMAINED IMPLANTED.

  Patient problems: Injury; Pain

  MAUDE report 9578293 ↗
• InjuryDec 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REASON FOR REVISION: TRUNNIONOSIS AND GROSSLY LOOSE TRITANIUM SHELL.

  Patient problems: Injury

  MAUDE report 9495544 ↗
• InjuryOct 14, 2019Malposition of Device; Noise, Audible; Malposition of Device; Noise, Audible

  PATIENT RETURNED TO DR'S OFFICE TO ASK THE PAIN IN HIS LEFT HIP DUE TO ARTHRITIS. DURING THIS APPOINTMENT THE PATIENT STATED HIS RIGHT HIP HAS STARTED CLICKING BUT WAS NOT PAINFUL. WHILE EXAMINING THE RADIOGRAPH DR NOTICED THE TRUNNIONS WAS NOT IN THE CENTER OF THE IMPLANT HEAD. IT LOOKED ECCENTRIC. A REVISION SURGERY WAS THEN SCHEDULED.

  Patient problems: Arthritis; Pain

  MAUDE report 9186215 ↗
• InjurySep 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT CAME TO CLINIC WITH UNSTABLE AND PAINFUL HIP. XRAY REVIEW WHAT APPEARS TO BE A DISSOCIATED HEAD FROM THE STEM. STEM WAS AN ACCOLADE TMZF WITH A 40 -4 HEAD. CUP IMAGE LOOKS NORMAL. PATIENT WAS SCHEDULED FOR A REVISION HIP SURGERY.

  Patient problems: Injury

  MAUDE report 9105197 ↗
• InjuryJul 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN AND ELEVATED CHROMIUM LEVELS. INTRA- OPERATIVELY, BLACK MATERIAL WAS NOTED INSIDE THE FEMORAL HEAD. THE FEMORAL HEAD AND LINER WERE REVISED TO A CERAMIC HEAD AND SLEEVE WITH AN MDM/ ADM LINER CONSTRUCT. THERE ARE NO ALLEGATIONS AGAINST THE LINER. REP CAN PROVIDE AN EXPLANT PICTURE AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 8836402 ↗
• InjuryJul 26, 2019Degraded; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Degraded; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS PI IS FOR THE RIGHT HIP. 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) 2008. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. PATIENT HAS NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE FEMORAL HEAD AT ISSUE. UPDATE 27-NOV-2019: COMMUNICATION RECEIVED FROM LEGAL STATING "PATIENT HAD UNDERDONE BILATERAL REVISION SURGERY ON (B)(6) 2019."

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

  MAUDE report 8833650 ↗
• InjuryJul 26, 2019Corroded; Insufficient Device Problem Information; Corroded; 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) 2011 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. UPDATE AS PER MEDICAL REVIEW: ". THE SURGEON FELT THE CUP WAS IN A SUBOPTIMAL VERTICAL POSITION. THE CUP WAS REVISED AND A NEW LINER PLACED. A SLEEVE AND NEW HEAD WERE IMPLANTED.AS WELL."

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

  MAUDE report 8833382 ↗
• InjuryJun 24, 2019Degraded; 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 LEFT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (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: Injury; Metal Related Pathology; Reaction

  MAUDE report 8727007 ↗