LFIT 6260-9-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 07613327032291), received between Jul 30, 2014 and Sep 8, 2026 — classified as 77 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (28 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 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Fracture

  The following information was provided: Patient, through counsel, alleges she underwent left THA on (b)(6) 2015 and was implanted with an LFIT V40 femoral head and Accolade TMZF hip stem which was revised on (b)(6) 2024 due to fracture of femoral neck of prosthesis.

  Patient problems: Insufficient Information

  MAUDE report 50666173 ↗
• InjurySep 24, 2025Material Erosion; Fracture; Detachment of Device or Device Component; Material Erosion; Fracture; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: TRUNION FRACTURE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 23137200 ↗
• InjuryJan 6, 2025Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED AFTER INITIAL COMPLAINT OF PAIN. SURGEON REPORTED PRESENCE OF PSEUDOTUMOR. INTRA-OPERATIVELY, CORROSION WAS NOTED INSIDE THE FEMORAL HEAD. THE TRUNNION WAS NOT OBSERVED TO HAVE ANY DAMAGE/ WEAR. THE HEAD AND LINER WERE REMOVED AND A NEW LINER WITH CERAMIC HEAD AND SLEEVE WERE IMPLANTED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT.

  Patient problems: Pain; Solid Tumor

  MAUDE report 21082764 ↗
• InjuryDec 11, 2024Degraded; Degraded

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2011 AND WAS IMPLANTED WITH AN LFIT V40 ANATOMIC FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HE WAS REVISED ON (B)(6) 2022 ALLEGEDLY DUE TO CHRONIC RIGHT HIP PAIN WITH MILDLY ELEVATED COBALT LEVELS.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 20909844 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO POSSIBLE OSTEOLYSIS AND PAIN. INTRA-OPERATIVELY, MARKINGS WERE FOUND ON THE TRUNNION AND INSIDE THE HEAD. STEM AND SHELL WERE NOTED TO BE WELL-FIXED. SURGEON CLEANED THE TRUNNION, PERFORMED A DEBRIDEMENT, AND REVISED A 36 -5 LFIT HEAD AND 10° 36E LINER TO A 36 +0 BIOLOX HEAD AND SLEEVE WITH ANOTHER 10° 36E LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 20621830 ↗
• InjuryAug 13, 2024Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "HEAD AND STEM ARE LOOSE." AN ACCOLADE STEM AND LIFT HEAD WERE REVISED TO A BIOLOX HEAD AND RESTORATION MODULAR STEM CONSTRUCT. UPDATE PER MEDICAL REVIEW: THE PREOPERATIVE X-RAY DID SHOW ECCENTRICITY OF THE HEAD NECK JUNCTION BUT DID NOT SHOW FRANK LOOSENING OF THE STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19971869 ↗
• InjuryJun 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2010 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2023, DUE TO ALLEGED HEAD DISSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 19640942 ↗
• InjuryApr 23, 2024Degraded; Degraded

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2013 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND AN ACCOLADE II HIP STEM. ALLEGEDLY IN THE LAST SEVERAL MONTHS SHE HAD INCREASING PAIN IN THE LEFT HIP, ELEVATED COBALT LEVEL SUGGESTING TRUNNIONOSIS AND WAS REVISED ON (B)(6) 2022.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19162768 ↗
• InjuryMar 20, 2024Fracture; Fracture

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE UNDERWENT REVISION SURGERY ON (B)(6) 2023, DUE TO ALLEGED FRACTURE THROUGH THE FEMORAL NECK OF THE STEM.

  Patient problems: Insufficient Information

  MAUDE report 18940306 ↗
• InjuryJan 8, 2024Degraded; Degraded

  THE PATIENT, THROUGH HER LAWYER, COMPLAINS OF HAVING SUFFERED PERMANENT DAMAGE FOLLOWING THE SURGERY PERFORMED ON (B)(6) 2012. THE PATIENT UNDERWENT TOTAL LEFT HIP PROSTHESIS SURGERY DUE TO A DIAGNOSIS OF COXARTHROSIS, DURING WHICH THE STRYKER ABG II MODULAR SYSTEM BRAND PROSTHESIS WAS IMPLANTED. AFTER A FEW YEARS, IN 2017, SHE COMPLAINED OF PERSISTENT LEFT COXALGIA AND WAS SUBJECTED TO MULTIPLE CLINICAL AND RADIOGRAPHIC CHECKS, AS WELL AS BLOOD CHEMISTRY TESTS WITH BLOOD DOSAGE OF CHROMIUM AND COBALT. IN THE FOLLOWING YEARS, AN INCREASINGLY GREATER INCREASE IN THE BLOOD LEVELS OF THE TWO IMPLANTED METALS WAS DETECTED. IN 2019, FOLLOWING THE DIAGNOSTIC INVESTIGATIONS CARRIED OUT, THE PATIENT WAS GIVEN AN INDICATION OF THE NEED TO PERFORM A PROSTHETIC REVISION SURGERY ON THE LEFT HIP DUE TO SUSPICION OF METALLOSIS. ON (B)(6) 2020, WHILE WAITING TO BE CONTACTED TO SCHEDULE THE SURGERY, WHILE SHE WAS AT HOME, SHE SUDDENLY SUFFERED A DISLOCATION OF HER LEFT HIP AND WAS TRANSPORTED TO THE EMERGENCY ROOM OF THE HOSPITAL, AND, ON (B)(6) 2020, UNDERWENT PROSTHETIC REVISION SURGERY. DURING THE SURGERY, AS WELL AS FOLLOWING THE HISTOLOGICAL EXAMINATION OF THE REMOVED PATHOLOGICAL TISSUE, THE

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18462684 ↗
• InjuryNov 4, 2023Degraded; Degraded

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2016, AND WAS IMPLANTED WITH A ACCOLADE II HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD. SHE WAS REVISED ON (B)(6) 2022 ALLEGEDLY DUE TO CHRONIC PAIN, ELEVATED COBALT LEVELS AND METALLOSIS.

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

  MAUDE report 18070548 ↗
• InjuryOct 5, 2023Corroded; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Corroded; Device Dislodged or Dislocated; 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) 2014, AND WAS REVISED ON (B)(6) 2023. IT IS FURTHER ALLEGED THAT THE PATIENT 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. UPDATE: PER MEDICAL RECORDS RECEIVED, THE REVISION OPERATIVE REPORT STATES THIS THA HAD DISLOCATED MULTIPLE TIMES NECESSITATING REVISION. INTRA-OPERATIVELY A GREAT DEAL OF METALLIC DEBRIS WAS ENCOUNTERED AS WELL AS A LARGE EFFUSION. UPON REMOVAL OF THE V-40 FEMORAL HEAD THE SURGEON REMARKED THE "TRUNNION WAS INTACT". COMPONENTS WERE "WELL FIXED". THE LINER WAS EXCHANGED TO ONE WITH AN ELEVATED RIM. A SLEEVE AND NEW HEAD WERE IMPLANTED.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 17874628 ↗
• InjuryOct 3, 2023Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED. AS REPORTED: "PATIENT WAS REVISED DUE TO PAIN AND SUSPECTED ACETABULAR COMPONENT LOOSENING. DURING SURGERY IT WAS NOTED THAT THE ACETABULAR COMPONENT WAS GROSSLY LOOSE. THERE WAS SOME PRESENCE OF CORROSIVE CHANGES ON THE TRUNNION AS WELL AS WITHIN THE FEMORAL HEAD. SURGEON ELECTED TO RETAIN THE FEMORAL COMPONENT AND PLACE A NEW ACETABULAR COMPONENT. A SLEEVED CERAMIC HEAD WAS IMPLANTED."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17866034 ↗
• InjuryJul 12, 2023Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  ON (B)(6) 2008 IMPLANTATION OF A STRYKER HIP PROSTHESIS WITH TRIDENT SCREW ACETABULAR CUP, PE INLAY, ACCOLADE STEM, METAL HEAD. IN THE COURSE NOW INCREASING INSTABILITY WITH MULTIPLE FALLS. ON (B)(6) 2023 EVIDENCE OF PREMATURE MATERIAL WEAR. V.A IMPLANT FRACTURE, REVISION SURGERY ON (B)(6) 2023 WITH MASSIVE METALLOSIS AND EVIDENCE OF COMPLETE WEAR OF THE METAL FEMORAL NECK.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 17306632 ↗
• InjuryJan 30, 2023Corroded; Device Dislodged or Dislocated; Corroded; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD ON HER LEFT HIP ON (B)(6), 2014. IT IS FURTHER ALLEGED THAT THE SUBJECT PRODUCTS MALFUNCTIONED AND/OR DISLODGED CAUSING INJURIES TO PATIENT, INCLUDING BUT NOT LIMITED TO ELEVATED COBALT LEVELS AND THE NEED FOR FURTHER SURGERY TO REPLACE THE STRYKER IMPLANTS.

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

  MAUDE report 16265599 ↗
• InjurySep 30, 2022Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER TO HEALTH CANADA THAT "PATIENT DEVELOPED A CATASTROPHIC WEAR OF THE TRUNNION OF THE FEMORAL IMPLANT WHICH LED TO A FRACTURE. PATIENT UNDERWENT A LEFT HIP REVISION ARTHROPLASTY."

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 15514538 ↗
• InjuryAug 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT IS A 68 YEAR OLD MALE WHO UNDERWENT SURGERY ON (B)(6) 2010 FOR A LEFT TOTAL HIP ARTHROPLASTY, PRESENTED WITH PAIN AND X-RAYS SHOWED A FEMORAL HEAD DISSOCIATION FROM THE TRUNNION OF THE STEM AS WELL AS THE TRUNNION FRACTURING OFF THE NECK OF THE BODY OF THE STEM AND FLOATING FREE IN THE JOINT SPACE. THE ORIGINAL STRYKER IMPLANTS IMPLANTED WERE: ACCOLADE TMZF SIZE 4X132 STEM, A 36-5 V40 COCR FEMORAL HEAD, A SIZE 54 TRIDENT HA HEMISPHERICAL ACETABULAR SHELL, AND TWO SCREWS, AND SIZE 36 E NEUTRAL X3 POLYETHYLENE LINER. NO IMPLANT RECORD AVAILABLE FOR THE FIRST SURGERY. THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM, A REVISION HIP WAS PERFORMED ON THE LEFT SIDE, THE TRUNNION WAS FRACTURED FROM THE STEM, THE HEAD WAS FREE IN THE ACETABULUM CAUSING IMPINGEMENT AND METALLOSIS. THERE WAS ADVERSE LOCAL TISSUE REACTIONS FROM THE TRUNNIONOSIS HOWEVER THE ADDUCTORS WERE IN TACT. ANOTHER COMPANY'S REVISION STEM WAS USED, THE TRIDENT CUP WAS RETAINED AND A NEW 36MM SIZE E 10 DEGREE LINER WAS PUT INTO THE CUP.

  Patient problems: Foreign Body Reaction

  MAUDE report 15300045 ↗
• InjuryAug 16, 2022Material Erosion; 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 HER LEFT HIP ON OR ABOUT (B)(6), 2014. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF THE IMPLANTATION, ELEVATED COBALT LEVELS AND THE NEED FOR FURTHER SURGERY TO REPLACE THE STRYKER IMPLANTS.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 15231111 ↗
• InjuryMay 14, 2022Degraded; 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 LEFT HIP ON OR ABOUT APRIL 4, 2013 AND WAS REVISED ON OCTOBER 29, 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: Metal Related Pathology

  MAUDE report 14403106 ↗
• InjuryApr 25, 2022Degraded; Degraded

  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) 2007 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: Metal Related Pathology

  MAUDE report 14197931 ↗
• InjuryApr 11, 2022Corroded; Degraded; Corroded; Degraded

  IT HAS BEEN REPORTED : "DUE TO A CHRONIC INFECTION, THE HYBRID TEP IMPLANTED ON (B)(6) 2016 HAD TO BE REMOVED ON (B)(6) 2022. ON THE EXPLANTED IMPLANTS, A CORROSION REACTION BETWEEN THE METAL HEAD AND THE STEM TAPER WAS NOTICED, WHICH EXCEEDED THE USUAL LEVEL".

  Patient problems: Unspecified Infection

  MAUDE report 14073716 ↗
• InjuryFeb 28, 2022Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. PRIOR TO REVISION SURGEON REPORTED HE BELIEVED THERE WAS IMPINGEMENT OF THE LINER ON THE STEM, AND INTRA-OPERATIVELY SURGEON REPORTED HE BELIEVED HE SAW WEAR ON THE LIP OF THE LINER. THE 36 -5 METAL HEAD AND 10° F LINER WERE REVISED TO A CERAMIC HEAD WITH -2.5 SLEEVE AND 0° F LINER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 13625823 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; 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), 2013 AND WAS REVISED ON (B)(6), 2020. IT IS FURTHER ALLEGED THAT SHE 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 HER BLOOD.

  Patient problems: Discomfort; Metal Related Pathology

  MAUDE report 13459172 ↗
• InjuryFeb 4, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO METALLOSIS AND INSTABILITY. A COCR HEAD, POLY LINER, SHELL, AND COMPETITOR SCREW WERE REVISED TO A NEW FEMORAL HEAD WITH A COMPETITOR SHELL AND LINER. THE STEM WAS RETAINED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Foreign Body Reaction; Joint Laxity

  MAUDE report 13452983 ↗
• InjuryJan 31, 2022Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; 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 HIS RIGHT HIP ON OR ABOUT (B)(6) 2014 AND WAS REVISED ON (B)(6) 2020. 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: Discomfort; Foreign Body Reaction; Metal Related Pathology

  MAUDE report 13392207 ↗