LFIT 6260-9-240Recalls & reported problems
Howmedica Osteonics Corp. · V40 Femoral Head · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is the LFIT femoral head from DePuy Synthes, the ball-shaped top of a hip implant used in hip replacement surgery. The 68 reports mostly describe the metal head coming loose or separating from its stem years after implantation, along with corrosion and wear at the junction, which led to pain, inflammation and revision surgery. There are 68 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 07613327032741), received between Jun 18, 2018 and May 27, 2026 — classified as 68 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (23 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information23
- Device Dislodged or Dislocated15
- Detachment of Device or Device Component13
- Corroded11
- Material Erosion10
- Degraded8
- Adverse Event Without Identified Device or Use Problem5
- Mechanical Problem1
Patient problems
- Injury33
- Pain25
- Reaction18
- Ambulation or Postural Difficulties12
- Inflammation11
- Insufficient Information11
- Metal Related Pathology11
- Foreign Body Reaction8
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT HIP SURGERY ON (B)(6) 2021 AND WAS IMPLANTED WITH LFIT V40 FEMORAL HEAD AND WAS SUBSEQUENTLY REVISED ON (B)(6) 2025 DUE TO ALLEGED HEAD DISASSOCIATION.
Patient problems: Insufficient Information
MAUDE report 25300032 ↗InjuryMar 3, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2018 WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF STEM WHICH WAS REVISED ON (B)(6) 2024 DUE TO ALLEGED HEAD DISASSOCIATION.
Patient problems: Insufficient Information
MAUDE report 24494639 ↗InjuryAug 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
CHRONIC DISLOCATION. THE PRIMARY SURGERY WAS NOT PERFORMED BY DR AND THE IMPLANT COMBINATIONS ARE COMPETITOR CUP WITH STRYKER STEM.
Patient problems: Joint Dislocation
MAUDE report 22892490 ↗InjuryFeb 5, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
NO NEW INFORMATION.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 21315305 ↗InjuryJan 6, 2025Corroded; Material Erosion; Material Erosion
IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2012 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE HIP STEM. HER RIGHT HIP WAS REVISED ON (B)(6) 2022 ALLEGEDLY DUE TO ALVAL FROM METAL HEAD FEMORAL NECK CORROSION.
Patient problems: Metal Related Pathology; Pain
MAUDE report 21080714 ↗InjuryDec 10, 2024Corroded; Corroded
IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2009 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HE WAS REVISED ON (B)(6) 2023 ALLEGEDLY DUE TO CORROSION.
Patient problems: Insufficient Information
MAUDE report 20896630 ↗InjuryNov 11, 2024Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNIONOSIS. SURGEON ALSO REPORTED THAT THE SHELL WAS NOT ANTEVERTED PROPERLY, CAUSING IMPINGEMENT OF THE LINER AND STEM. AN ACCOLADE STEM, 40MM FEMORAL HEAD, AND LINER WERE REVISED TO COMPETITOR FEMORAL IMPLANTS AND A NEW STRYKER LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 20659795 ↗InjuryOct 29, 2024Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component
PATIENT HAD A RIGHT HIP REVISION DUE TO PAIN, NOISE IN HIP AND THE HEAD DISASSOCIATING FROM THE STEM.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 20556622 ↗InjuryOct 16, 2024Corroded; Corroded
IT WAS REPORTED BY COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2014 AND WAS IMPLANTED WITH AN LFIT COCR FEMORAL HEAD. HE WAS REVISED ON (B)(6) 2023, DUE TO ALLEGED CORROSION.
Patient problems: Insufficient Information
MAUDE report 20460233 ↗InjurySep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
SEPARATION OF STEM FROM HEAD DUE TO BROKEN TRUNNION.
Patient problems: Insufficient Information
MAUDE report 20240561 ↗InjuryAug 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PATIENT REVISED FOR FAILURE OF LEFT TOTAL HIP ARTHROPLASTY. GRAY TISSUE STAINING. DISSOCIATED HEAD AND STEM TRUNNION DAMAGE WERE NOTED. STEM AND HEAD WERE EXPLANTED AND REPLACED WITH NEW STEM (BELOW BILLING SHEET). CUP AND INSERT WERE RETAINED.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 20075072 ↗InjuryApr 30, 2024Corroded; Corroded
IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2014, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND A SECUR FIT ADVANCED STEM. RECENTLY HE FELT SOMETHING MOVING AND PRESENTED WITH LEFT HIP DISCOMFORT. HE WAS REVISED ON (B)(6) 2023, AND INTRAOPERATIVELY THE SURGEON NOTED "TRUNNION WAS VISUALIZED AND WAS CORRODED AND DEFORMED".
Patient problems: Discomfort
MAUDE report 19215324 ↗InjuryApr 12, 2024Corroded; Corroded
PATIENT'S WIFE REPORTED HUSBAND EXPERIENCING BURSITIS ON RIGHT HIP AND MAY REQUIRE A REVISION. PATIENT REPORTED HAVING SURGERY ON THE SURROUNDING TISSUE BUT NO IMPLANTS WERE EXPLANTED. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL. UPDATE: "IS HE HAS A TUMOR WITH FLUID AND METAL SHAVINGS IN IT . PRETTY SCARY THAT HE NEEDS TO HAVE ANOTHER SURGERY FOR REVISION." UPDATE 28-FEB-2024: PER REVISION OP. REPORT, PATIENT WAS REVISED ON (B)(6) 2023. UPDATE AS PER MED REVIEW: THE SURGEON DID NOTE IN THE REVISION OPERATIVE REPORT THAT THE SHELL WAS IN 25 TO 30 DEGREES OF ANTEVERSION. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: "THE SURGEON NOTED THAT THE ACETABULAR COMPONENT WAS IN "25 TO 30DEGREES OF ANTEVERSION" . IN MOST CASES THIS IS WITHIN THE NORMAL RANGE OF PLACEMENT. HE DID NOT REVISE THE METAL ACETABULAR SHELL TO CORRECT THIS ANTEVERSION. INSTEAD, HE REVISED THE LINER TO A 10-DEGREE LIPPED COMPONENT. ALTHOUGH HE NOTES THAT THIS IS MEANT TO "DECREASE THE ANTEVERSION" IN FACT IT DOES NOT CHANGE THE ANTEVERSION OF THE CUP. IT INCREASES COVERAGE OF THE FEMORAL HEAD. NO EVIDENCE WAS PROVIDED TO CONFIRM ACETABULAR SHELL PLACEMENT CONTRIBUTED
Patient problems: Bursitis; Foreign Body Reaction; Metal Related Pathology; Pain
MAUDE report 19095993 ↗InjuryJan 8, 2024Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO METALLOSIS. A FEMORAL HEAD AND LINER WERE REVISED. 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: Metal Related Pathology
MAUDE report 18462902 ↗InjuryJan 5, 2024Corroded; Corroded
IT WAS REPORTED BY COUNSEL THAT PATIENT UNDERWENT LEFT THA ON (B)(6) 2018, AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE II HIP STEM. HE WAS REVISED ON (B)(6) 2022, ALLEGEDLY DUE TO CORROSION.
Patient problems: Insufficient Information; Metal Related Pathology
MAUDE report 18450459 ↗InjuryNov 4, 2023Degraded; Material Erosion; Degraded; Material Erosion
IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2014, AND WAS IMPLANTED WITH A ACCOLADE II HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD. HE WAS REVISED ON (B)(6) 2020 ALLEGEDLY DUE TO WEAKNESS AND PAIN, ELEVATED METAL IONS, AND ADVERSE SOFT TISSUE REACTION SECONDARY TO TRUNIONNOSIS.
Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain
MAUDE report 18070552 ↗InjurySep 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT WAS IMPLANTED WITH AN ACCOLADE TMZF HIP STEM AND LFIT ANATOMIC V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2009. IT IS ALLEGED THAT HE DEVELOPED SEVERE PAIN IN THE RIGHT HIP AND THE INABILITY TO WALK OR BEAR WEIGHT ON THE RIGHT LEG, TRUNNIONOSIS, ALMOST COMPLETE DISASSOCIATION BETWEEN THE FEMORAL HEAD AND NECK, AND A METALLOSIS. HE WAS REVISED ON (B)(6) 2022.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 17763935 ↗InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT WAS IMPLANTED WITH AN ACCOLADE TMZF HIP STEM AND LFIT ANATOMIC V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2009. IT IS ALLEGED THAT THE PATIENT HAS BEEN EXPERIENCING SEVERE PAIN IN HIS LEFT HIP AND IS CURRENTLY BEING EVALUATED AND IT APPEARS HE WILL BE REQUIRED TO UNDERGO REVISION SURGERY ON HIS LEFT HIP IN THE NEAR FUTURE.
Patient problems: Pain
MAUDE report 17747959 ↗InjurySep 5, 2023Material Erosion; Material Erosion
IT WAS REPORTED BY PATIENT'S ATTORNEY THAT ALLEGEDLY THE PATIENT UNDERWENT BILATERAL HIP ARTHROPLASTY ON (B)(6) 2010, AND WAS IMPLANTED WITH ACCOLADE TMZF HIP STEMS AND LFIT V40 FEMORAL HEADS. IT IS FURTHER ALLEGED THE RIGHT HIP WAS REVISED ON (B)(6) 2021 AND DURING REVISION IT WAS NOTED THAT THE TRUNNION HAD BEEN FILED DOWN TO A POINT LIKE STRUCTURE BASED ON THE MOVEMENT OF THE HEAD AROUND THE PROXIMAL FEMUR.
Patient problems: Insufficient Information
MAUDE report 17687101 ↗InjuryMar 30, 2023Corroded; Corroded
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SHE UNDERWENT REVISION SURGERY ON (B)(6) 2021 AND INTRAOPERATIVELY THE SURGEON NOTED "THE TAPER WAS COMPLETELY CORRODED AD WHITTLED DOWN TO A PENCIL TYPE SHAPE."
Patient problems: Ambulation or Postural Difficulties
MAUDE report 16644367 ↗InjuryDec 12, 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 V40 COCR LFIT FEMORAL HEAD ON HIS LEFT HIP ON (B)(6) 2009. IT IS FURTHER ALLEGED THAT THE PATIENT EXPERIENCED PAIN. X-RAYS ALLEGEDLY SHOWED "BROKEN, WORN OUT TRUNNION AND THE ACETABULAR SOCKET APPEARED TO BE IN GOOD CONDITION." DURING REVISION SURGERY ON (B)(6) 2020, "THE WORN OUT TRUNNION WAS COMPLETELY CORRODED AND WEARING ON A SUPERIOR PORTION OF THE SOCKET. THE PLASTIC LINER WAS BROKEN IN THIS AREA AS WELL."
Patient problems: Pain
MAUDE report 15965367 ↗InjuryNov 1, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO TRUNNION WEAR AND DISSOCIATION OF THE HEAD FROM THE STEM. REP WAS NOT PRESENT FOR THE PROCEDURE. THE STEM, HEAD AND LINER WERE REVISED.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 15712569 ↗InjuryOct 4, 2022Corroded; Material Erosion; Corroded; 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), 2015 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: Fall; Metal Related Pathology; Swelling/ Edema
MAUDE report 15534773 ↗InjurySep 29, 2022Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
REVISION SURGERY WAS PERFORMED DUE TO HEAD DISLOCATION AND STEM NECK SHAVING. A BLACK DISCOLORATION OF THE BONE AND SOFT TISSUE WITHIN THE JOINT WERE REVEALED AT THE REVISION. THERE WAS NO BONE FRAGILITY OR SOFT TISSUE LOSS. THE CUP CONTINUED TO BE USED AND THE INSERT WAS REPLACED DUE TO AGE-RELATED WEAR.
Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction
MAUDE report 15507509 ↗InjuryAug 1, 2022Material Erosion; Material Erosion
IT WAS REPORTED THROUGH CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD AND SUBSEQUENTLY DEVELOPED PROGRESSIVE HIP PAIN WITH ELEVATED COBALT AND CHROMIUM LEVELS. THE PATIENT WAS REVISED ON (B)(6) 2021 AND THE SURGEON NOTED "FEMORAL HEAD AND TRUNNION WERE COATED IN A DARK BLACK SUBSTANCE" WITH REMOVAL OF ALL COMPONENTS.
Patient problems: Foreign Body Reaction; Pain
MAUDE report 15137423 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page