LFIT 6260-9-144Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327032734), received between Jun 19, 2018 and Mar 20, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  REP WAS CONTACTED WITH A REQUEST TO SEE IF A 40 +0 LFIT V40 HEAD WAS RECALLED. LEFT HIP. REVISION (IN THE COMING MONTHS) DUE TO METALLOSIS.

  Patient problems: Foreign Body Reaction

  MAUDE report 24648079 ↗
• InjuryApr 16, 2024Fracture; Fracture

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2009 AND WAS IMPLANTED WITH AN LFIT V40 COCR FEMORAL HEAD AND AN ACCOLADE TMZF HIP STEM. HE WAS REVISED ON (B)(6) 2021 DUE TO ALLEGED FRACTURED TRUNNION AND PARTIAL DISLOCATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19122657 ↗
• InjuryNov 2, 2023Degraded; Degraded

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT HIP SURGERY ON (B)(6) 2010, AND WAS IMPLANTED WITH A RESTORATION MODULAR HIP SYSTEM AND A LFIT V40 COCR FEMORAL HEAD. HE WAS REVISED ON (B)(6) 2022, DUE TO PAIN, ELEVATED COBALT AND CHROMIUM LEVELS AND ALTR.

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

  MAUDE report 18054162 ↗
• InjuryFeb 22, 2023Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. ORIGINALLY, SURGEON SUSPECTED THE STEM HAD SUBSIDED 8-10MM. HOWEVER, INTRA-OPERATIVELY THE STEM WAS NOT FOUND TO BE LOOSE. BLACK DEBRIS WAS FOUND IN THE HIP CAPSULE AND DOWN THE FEMUR. A DEBRIDEMENT WAS PERFORMED. THE FEMORAL HEAD WAS ABLE TO BE REMOVED BY HAND AND THE TRUNNION OF THE STEM OBSERVED TO BE WORN DOWN TO A PENCIL SHAPE. THE STEM, HEAD AND LINER WERE REVISED (NO DAMAGE OR WEAR OF THE LINER WAS NOTED).

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 16416147 ↗
• InjuryDec 15, 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 LEFT HIP ON OR ABOUT (B)(6) 2022 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 AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 15986000 ↗
• InjuryDec 9, 2021Adverse 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 HIS RIGHT HIP ON OR ABOUT (B)(6) 2009 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(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 12973171 ↗
• InjuryAug 16, 2021Degraded; 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 ON OR ABOUT (B)(6), 2016 THE PATIENT UNDERWENT SURGERY OF THE RIGHT HIP AND WAS IMPLANTED A STRYKER TOTAL HIP SYSTEM. IT IS FURTHER ALLEGED THAT ON OR ABOUT (B)(6), 2021 THE PATIENT COMPLAINED OF A STABBING AND RADIATING PAIN IN HIS RIGHT HIP, STIFFNESS, WEAKNESS, LIMITED RANGE OF MOTION AND MOBILITY AND WORSENING PAIN WITH ACTIVITY. THE PATIENT WAS REVISED ON OR ABOUT (B)(6), 2021 AND ALLEGEDLY THE SURGEON INTRAOPERATIVELY NOTED " PSEUDOTUMOR, TRUNNIONOSIS, BLACK STAINED TISSUE AND ADVERSE LOCAL TISSUE REACTION" AND "CUP WAS BROKEN LOOSE WITH MINIMAL EFFORT" AND THERE WAS NO BONY INGROWTH. THE SHELL, LINER AND FEMORAL HEAD WERE REMOVED AND REPLACED.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Loss of Range of Motion; Pain

  MAUDE report 12323566 ↗
• InjuryAug 13, 2021Material Erosion; Device Dislodged or Dislocated; Material Erosion; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S HIP WAS REVISED. REVISION IMPLANTS WERE A RESTORATION MODULAR STEM CONSTRUCT, BIOLOX DELTA 28 +0 HEAD, AN ADM/MDM LINER CONSTRUCT, AND A DOSE OF HYDROSET CEMENT. UPDATE: HEAD DISASSOCIATION, TRUNNION WEAR & METALLOSIS.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology; Pain

  MAUDE report 12317362 ↗
• InjuryFeb 18, 2021Degraded; Material Erosion; Degraded; Material Erosion

  REVISION OF ACCOLADE I WITH TRUNNION WEAR.

  Patient problems: Insufficient Information

  MAUDE report 11345314 ↗
• InjuryFeb 4, 2021Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated; Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated

  LEFT HIP REVISION FOR PAIN AND ELEVATED COBALT AND CHROMIUM LEVELS. ALL IMPLANTS REMOVED AND REPLACED. UPDATE: "THE SURGEON DID NOT ALLEGE ANYTHING AGAINST THE SHELL. THE CUP WAS REVISED FOR PAIN AND ELEVATED COBALT AND CHROME LEVELS AS STATED IN THE INITIAL REPORT."

  Patient problems: Pain

  MAUDE report 11279433 ↗
• InjuryJan 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNION FAILURE. INTRA-OPERATIVELY, THE HEAD WAS FOUND TO BE TOGGLING ON THE SEVERELY WORN TRUNNION AND A COPIOUS AMOUNT OF BLACK TISSUE AND FLUID WERE NOTED. 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. REP REPORTED THAT SOME PICTURES CAN BE PROVIDED AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Failure of Implant

  MAUDE report 11129637 ↗
• InjuryAug 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED THAT AN IMPLANT FAILED IN A PATIENT WHO HAD BEEN IMPLANTED WITH A TRIDENT ACCOLADE COMBINATION. ACCOLADE STEM, FEMORAL HEAD AND POLY LINER WERE ALL EXPLANTED. THE TRIDENT CUP THAT WAS IN SITU WAS PERFECT SO WASN¿T EXPLANTED. THIS PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH RIP HIP PAIN. HIS X-RAYS SHOWS SIGNS OF GROSS TRUNNION FAILURE AND FEMORAL HEAD ¿ NECK DISSOCIATION. HE UNDERWENT REVISION RIGHT HIP SURGERY ON (B)(6) 2020 WHEN THE AFFECTED EXPLANT WAS RETRIEVED. THE PATIENT'S METAL ION LEVELS WERE: SERUM COBALT (CO) LEVEL OF 274 NMOL/L (NORMAL, <10 NMOL/L), SERUM CHROMIUM (CR) LEVEL OF 94 NMOL/L (NORMAL, <15 NMOL/L).

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Reaction; Reaction to Medicinal Component of Device

  MAUDE report 10355356 ↗
• InjuryJun 9, 2020Degraded; Detachment of Device or Device Component; Insufficient Device Problem Information; Degraded; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A BROKEN TRUNNION. AN ACCOLADE STEM AND 44MM FEMORAL HEAD (COMPOSITION AND OFFSET UNKNOWN) AND A DISCOLORED LINER WERE REVISED TO ANOTHER STRYKER LINER AND COMPETITOR FEMORAL COMPONENTS.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10135592 ↗
• InjuryFeb 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PATIENT UNDERWENT HIP REVISION SURGERY FOR PAIN AND ELEVATED SERUM METAL ION LEVELS." PICTURES PROVIDED OF AN EXPLANTED STEM, HEAD, LINER, AND SHELL. UPDATE: SPOKE TO REP. THERE ARE NO ALLEGATIONS AGAINST THE REVISED SHELL OR LINER, SURGEON SIMPLY WANTED TO REVISE THE SHELL.

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 9759125 ↗
• InjuryNov 6, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  SURGEON REVISED PRIOR THA FOR LOOSE FEMORAL HEAD. FEMORAL HEAD LOOSE ON TAPER.

  Patient problems: Injury

  MAUDE report 9285963 ↗
• InjuryOct 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS AT HIS ACCOUNT AND CROSSED HIS LEGS AND HEAD DISASSOCIATED FROM STEM. UPDATE: 17/SEPTEMBER/2019 WG: SPOKE TO REP. A RIGHT HIP X-RAY FROM (B)(6) 2019, USAGE SHEET, AND EXPLANT PICTURE WERE PROVIDED. REP CONFIRMED NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9177037 ↗
• InjurySep 24, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. REP REPORTED THERE WERE THREE GELATINOUS MASSES ON THE PATIENT'S HIP WHICH EXTENDED DOWN TO THE STEM (NOT REPORTED AS PSEUDOTUMOR). FLUID COULD NOT BE EXTRACTED FROM THE MASSES PRE-REVISION, TISSUE WAS SENT TO BE EXAMINED. NO BLACK TISSUE WAS NOTED IN THE PATIENT'S JOINT. NO BLACK MATERIAL/ CORROSION WAS NOTED AT THE HEAD/ TRUNNION INTERFACE. NO TRUNNION WEAR WAS NOTED. PATIENT FACTOR: LYMPHOMA WITHIN THE PAST YEAR. PATIENT'S FEMORAL HEAD AND LINER WERE REVISED TO A V40 +4 SLEEVE, 44 BIOLOX HEAD, AND THE SAME CATALOG NUMBER LINER (DIFFERENT LOT). UPDATE 27 AUGUST, 2019: MATERIAL ANALYSIS NOTED THE FOLLOWING: EDS SHOWED THE HEAD WAS CONSISTENT WITH ASTM F1537 AND THE DEBRIS ON THE INTERIOR TAPER WAS CONSISTENT WITH AN OXIDE, A CORROSION PROCESS, AND BIOLOGICAL MATERIAL. BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIALS OR MANUFACTURING DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED.

  Patient problems: Injury

  MAUDE report 9108973 ↗
• InjurySep 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTER STATES: "THE PATIENT HAD A HIP REPLACEMENT DONE ON (B)(6) 2010. THE OPERATION WAS SUCCESSFUL. ON (B)(6) 2019 THE HIP COLLAPSED LEAVING THE PATIENT UNABLE TO MOVE. THE PATIENT WAS ADMITTED WHERE THE PATIENT HAD ANOTHER HIP REPLACEMENT. THE SHAFT OF THE OLD HIP HAD COMPLETELY WORN AWAY. THE PATIENT HAS BEEN THROUGH 2 MORE OPERATIONS AND AN APPALLING INFECTION."

  Patient problems: Injury

  MAUDE report 8959749 ↗
• InjuryApr 26, 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 THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2009 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

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

  MAUDE report 8555754 ↗
• InjuryApr 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "HEAD DETACHED FROM TRUNNION. TRUNNION WORE OUT BY METAL HEAD..." ORTHOPEDIC CONSULTATION PROVIDED BY THE REP NOTES PATIENT COMPLAINT OF PAIN STARTING APPROXIMATELY 2017 EVENTUALLY BECOMING SEVERE. PATIENT "TURNED SUDDENLY AND FELT IMMEDIATE PAIN AND POP RIGHT INGUINAL [GROIN] REGION" WITH A FINDING OF A FRACTURE OF THE STEM AT THE HEAD NECK JUNCTION AND STEM MIGRATION. OPERATIVE REPORT FOR REVISION REPORTS"...A SIGNIFICANT AMOUNT OF METAL STAINED SYNOVIAL FLUID...ALSO SIGNIFICANT METAL STAINED SYNOVITIS...FEMORAL STEM WAS NOTED TO BE GROSSLY LOOSE WITH SIGNIFICANT OSTEOLYSIS ABOUT THE PROXIMAL FEMUR". PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, V40 28 -2.7 CERAMIC HEAD, MDM/ADM LINER CONSTRUCT, AND A COMPETITOR CABLE PLACED "TO HELP PROPHYLAX AGAINST PERIPROSTHETIC FRACTURE" (NO BONE FRACTURES ARE NOTED IN THE OPERATIVE REPORT). REP PROVIDED THE ORTHOPEDIC CONSULTATION VISIT, REVISION OPERATIVE REPORT, PRE- AND POST-REVISION X-RAYS AND EXPLANT PICTURES.

  Patient problems: Injury; Pain

  MAUDE report 8477782 ↗
• InjuryNov 27, 2018Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION. INTRA-OPERATIVELY, PSEUDO TUMOR WAS REPORTED WITH AN EXCESSIVE AMOUNT OF BLACK TISSUE OBSERVED. THE TRUNNION WAS FOUND TO BE WORN DOWN AND THE LINER WAS WORN THROUGH IN AT LEAST 2 PLACES. THE SHELL WAS WELL-FIXED AND NOT REVISED. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A 28 +8 METAL HEAD.

  Patient problems: Edema; Inflammation; Injury; Reaction

  MAUDE report 8108641 ↗
• InjurySep 18, 2018Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN AND INSTABILITY. THE HEAD WAS FOUND TO BE DISASSOCIATED FROM THE STEM. INTRA-OPERATIVELY, BLACK TISSUE WAS NOTED IN THE CAPSULE. THE STEM, HEAD, AND LINER (NO WEAR NOTED ON LINER) WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A CERAMIC HEAD AND POLY LINER.

  Patient problems: Injury; Pain

  MAUDE report 7887424 ↗
• InjurySep 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON REVISED A STEM, HEAD AND LINER DUE TO TRUNNIONOSIS. ORIGINAL SURGERY WAS (B)(6) 2007. UPDATE 23/AUGUST/2018: REP PROVIDED EXPLANT PICTURES, PRE-REVISION X-RAYS, PRIMARY OPERATIVE REPORT, AND USAGE SHEETS FROM PRIMARY AND REVISION PROCEDURES. EXPLANT PICTURE SHOWS WEAR ON THE RIM OF THE POLY INSERT AND PRE-REVISION X-RAYS SHOW THE HEAD DISASSOCIATED FROM THE STEM.

  Patient problems: Injury

  MAUDE report 7883074 ↗
• InjuryJun 19, 2018Degraded; Degraded

  THE CUSTOMER REPORTED IN HIS LETTER TO STRYKER UK THAT HE UNDERWENT AN EMERGENCY REVISION OF HIS ACCOLADE / LFIT V40 RIGHT HIP REPLACEMENT AT THE PRINCESS ROYAL HOSPITAL, HAYWARDS HEATH ON THE (B)(6) 2017 FOLLOWING EXTREME PAIN. SUPPLEMENTARY DOCUMENTATION PROVIDED BY THE PATIENT STATES THAT DURING THE REVISION, THE SURGEON, MR PS, FOUND EXTENSIVE METALLOSIS FROM A WORN TRUNNION THAT WAS GRINDING INTO THE BONE ANTEROSUPERIORLY TO THE SOCKET, A DARK GREY FLUID WITHIN THE JOINT, POCKETS OF PSEUDOTUMOUR, BONE NECROSIS AND SIGNIFICANT MUSCLE DAMAGE AROUND THE HIP. ENCLOSED NJR RECORDS SHOW THAT THE PRIMARY OPERATION WAS COMPLETED ON 3RD OCTOBER 2009 AT THE SUSSEX ORTHOPEDIC NHS TREATMENT CENTRE BY MR TM, AND THAT THE PATIENT WAS REVISED TO A RESTORATION MODULAR CONICAL DISTAL STEM, RESTORATION MODULAR CONE BODY, V40 DELTA CERAMIC HEAD AND A TRIDENT CONSTRAINED LINER. THE ENCLOSED OPERATION NOTES STATE THAT THE PATIENT SUFFERED A GREATER TROCHANTER FRACTURE DURING THE REVISION WHICH WAS FIXATED WITH A LARGE DALL MILES HOOK PLATE, 2 X DALL MILES CABLES AND X 2 LARGE FRAGMENT SCREWS.

  Patient problems: Edema; Inflammation; Injury; Necrosis; Pain; Reaction

  MAUDE report 7616959 ↗