LFIT 6260-9-140Recalls & 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 Howmedica LFIT Anatomic femoral head is the ball-shaped top part of a cemented hip replacement. The 69 reports mostly describe a worn, corroded or eroding metal surface that eventually breaks loose or comes apart, with patients reporting hip pain, clicking and grinding, difficulty walking, and metal-related tissue reaction, often needing revision surgery; 69 injuries and no deaths are described. No recalls name this device. Reports have slowed, from 8 in the earlier 12 months to 2 in the most recent 12 months.
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
- 69
- Deaths reported
- 0
- Injuries reported
- 69
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 07613327032727), received between Jun 20, 2018 and Mar 17, 2026 — classified as 69 injuries.
The most frequently reported specific device problem is “Degraded” (26 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
- Degraded26
- Insufficient Device Problem Information25
- Detachment of Device or Device Component17
- Material Erosion9
- Corroded8
- Adverse Event Without Identified Device or Use Problem5
- Device Dislodged or Dislocated4
- Unstable3
Patient problems
- Injury32
- Pain30
- Ambulation or Postural Difficulties15
- Reaction15
- Metal Related Pathology14
- Inflammation12
- Foreign Body Reaction10
- Insufficient Information10
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Degraded; Unstable
THE FOLLOWING INFORMATION WAS PROVIDED: LEFT HIP REVISION FOR PAIN AND INSTABILITY. CUP, INSERT, SCREWS, AND HEAD REVISED. REPLACED WITH COMPETITOR CUP AND DUAL MOBILITY WITH STRYKER HEAD AND SLEEVE.
Patient problems: Inadequate Osseointegration; Joint Laxity; Pain
MAUDE report 24616801 ↗InjuryDec 12, 2025Degraded; Material Erosion; Noise, Audible; Degraded; Material Erosion; Noise, Audible
THE FOLLOWING INFORMATION WAS PROVIDED: PT. REPORTED; I JUST HAD A TOTAL HIP REVISION SURGERY TO REPLACE THE L FIT ANATOMIC V40 THAT APPARENTLY HAD BEEN RECALLED. PT. MENTIONED SHE HAD BEEN IN A LOT OF PAIN WITH CLICKING AND GRINDING. STATED THAT BLACK FLUID POURED OUT WHEN THE IMPLANT WAS REMOVED.
Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain
MAUDE report 23788969 ↗InjuryOct 15, 2025Degraded; Degraded
NO NEW INFORMATION.
Patient problems: Cyst(s); Foreign Body Reaction; Metal Related Pathology; Pain
MAUDE report 23300516 ↗InjuryJul 11, 2025Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO EXCESSIVE TRUNNION WEAR. THE STEM, HEAD AND LINER WERE REVISED TO A NEW STRYKER LINER AND COMPETITOR FEMORAL IMPLANTS. 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 22477355 ↗InjuryMay 19, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PAIN AND VISUAL (IMPLANT) DEFORMITY. CLICKING. ALL AVAILABLE INFORMATION SUBMITTED.' STEM WITH A VERY WORN TRUNNION.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 22042707 ↗InjuryMar 24, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
BROKEN HIP PROSTHESIS. THE REVISION OF THE HIP TOOK PLACE TODAY.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 21676639 ↗InjuryDec 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2009 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. THE PATIENT WAS REVISED ON (B)(6) 2021 ALLEGEDLY DUE TO HEAD DISASSOCIATION.
Patient problems: Insufficient Information
MAUDE report 20896289 ↗InjuryNov 26, 2024Corroded; Degraded; Corroded; Degraded
IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2014, AND WAS IMPLANTED WITH A LFIT ANATOMIC V40 FEMORAL HEAD. SUBSEQUENTLY HE DEVELOPED PAIN IN HIS GROIN, LATERAL HIP AND BUTTOCKS WITH ANY MOTION AND FELT HE WAS GETTING WEAK AND GETTING WORSE. ALLEGEDLY HIS COBALT CHROME LEVELS WERE NOT SIGNIFICANTLY ELEVATED BUT MRI WAS CONCERNING FOR POSSIBLE ADVERSE LOCAL TISSUE REACTION. HE WAS REVISED ON (B)(6) 2021 FOR ALLEGED TRUNNIONOSIS AND HEAD/TAPER CORROSION.
Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain
MAUDE report 20787098 ↗InjuryNov 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTED: IT WAS NECESSARY TO REMOVE THE HIP PROSTHESIS DUE TO THE WEAR OF THE TAPER OF THE STEM (6020-0335) IN THE IMPLANT WITH A 40 DIAMETER HEAD (6260-9-140) WHICH DISLOCATED IN THE NECK, IT WAS ALSO NECESSARY TO REMOVE THE INSERT (623-00-40G).
Patient problems: Insufficient Information
MAUDE report 20785501 ↗InjuryNov 24, 2024Degraded; Degraded
IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2013 AND WAS IMPLANTED WITH A LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE II HIP STEM. SUBSEQUENTLY HE DEVELOPED PERSISTENT PAIN WHICH ALLEGEDLY WAS PAINFUL WITH WALKING, WITH WEIGHTBEARING AND HAD PAIN WITH RANGE OF MOTION IN HIS HIP. HE WAS REVISED ON (B)(6) 2020, AND INTRAOPERATIVELY THE SURGEON NOTED CHEESY PASTE-LIKE MATERIAL IN HIS JOINT AND SOME METALLOSIS BETWEEN THE FEMORAL HEAD AND THE TRUNNION.
Patient problems: Foreign Body Reaction
MAUDE report 20768690 ↗InjuryJun 7, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
IT WAS REPORTED THE PATIENT HAD A HIP REVISION DUE TO DISASSOCIATION. IT WAS ALSO NOTICED THE TRUNNION WAS WORN.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 19484543 ↗InjuryMay 3, 2024Material Erosion; Material Erosion
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, THE FOLLOWING WAS ALSO NOTED: TRUNNIONOSIS ('BIRD BEAK'), BLACK TISSUE, PSEUDOTUMOR. THE STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, ADM/ MDM POLY INSERT, AND MDM METAL LINER. THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER. REP CAN PROVIDE ADDITIONAL PICTURES, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Foreign Body Reaction
MAUDE report 19236450 ↗InjuryJan 4, 2024Material Erosion; Material Erosion
IT WAS REPORTED BY COUNSEL THAT PATIENT UNDERWENT RIGHT THA ON (B)(6) 2015, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM. HIS RIGHT HIP WAS REVISED ON (B)(6) 2022, DUE TO PAIN AND ELEVATED METAL IONS IN HIS SERUM.
Patient problems: Metal Related Pathology; Pain
MAUDE report 18444795 ↗InjuryDec 11, 2023Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNIONOSIS AND METALLOSIS. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: TRUNNION WEAR, FEMORAL HEAD WAS LOOSE YET WEDGED ON THE TRUNNION, BLACK TISSUE IN THE PATIENT. THE STEM, HEAD, AND LINER WERE REVISED (THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER). REP CAN PROVIDE PICTURES AND OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON.
Patient problems: Foreign Body Reaction; Insufficient Information; Metal Related Pathology
MAUDE report 18307669 ↗InjuryOct 31, 2023Degraded; Degraded
IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT A RTHA ON (B)(6) 2010 WHERE AN ACCOLADE TMZF HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD WERE IMPLANTED. ALLEGEDLY SHE WAS REVISED ON (B)(6) 2020 DUE TO ELEVATED COBALT LEVELS, ALTR AND FLUID COLLECTION.
Patient problems: Foreign Body Reaction; Metal Related Pathology
MAUDE report 18038039 ↗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 LEFT HIP WAS REVISED ON (B)(6) 2021, DUE TO SEVERE TRUNNIONOSIS WITH DISLOCATION OF THE FEMORAL HEAD. DURING THE REVISION SURGERY THE TRUNNION WAS NOTED TO BE GROSSLY DEFORMED AND TAPERED TO A SHARP POINT.
Patient problems: Insufficient Information
MAUDE report 17687220 ↗InjuryAug 2, 2023Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. INTRA-OPERATIVELY, THE TRUNNION WAS FOUND TO BE WORN/ DEFORMED. THE STEM, HEAD AND LINER WERE REVISED.
Patient problems: Pain
MAUDE report 17446681 ↗InjuryJun 6, 2023Degraded; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Degraded; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON (B)(6) 2012, THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD AND AN ACCOLADE HA HIP STEM. IT IS FURTHER ALLEGED THE PATIENT HAD ELEVATED COBALT AND CHROMIUM LEVELS AND WAS REVISED ON (B)(6) 2022.
Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology; Pain
MAUDE report 17069424 ↗InjuryApr 2, 2023Corroded; Corroded
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY ON (B)(6) 2008. SHE UNDERWENT REVISION ON (B)(6) 2022 WITH A PREOPERATIVE DIAGNOSIS OF CORROSION RIGHT HIP. AFTER REMOVING THE LARGE METAL HEAD, "THERE WAS EVIDENCE OF SOME CORROSION AT THE BASE OF THE TAPER."
Patient problems: Insufficient Information
MAUDE report 16661047 ↗InjuryMar 8, 2023Material Erosion; Material Erosion
InjuryDec 5, 2022Degraded; Unstable; Degraded; Unstable
PATIENT WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD ON HER LEFT HIP ON (B)(6) 2010. IT IS FURTHER ALLEGED THAT SHE NOTED INCREASING PAIN AND FEELING OF INSTABILITY IN HER HIP. X-RAYS OBTAINED IN OCTOBER ALLEGEDLY SHOWED TRUNION DAMAGE AND THE HEAD ON AN ANGLE. DURING REVISION SURGERY ON NOVEMBER 15, 2019, "THE BALL WAS GROSSLY LOOSE ON THE TRUNNION AND"..."THE TIP OF THE TRUNNION HAD BEEN WHITTLED DOWN TO A SHARP POINT." "THERE WAS GROSS DAMAGE FROM THE SHARP TRUNNION TIP RIDING INTO THE POLYETHYLENE."
Patient problems: Joint Laxity; Pain
MAUDE report 15913356 ↗InjuryNov 29, 2022Degraded; Material Erosion; Degraded; Material Erosion
SALES REP REPORTED: "I GOT A PHONE CALL FROM DR., HE REPORTS THAT ONE OF THESE PATIENTS WITH AN ABG II PROSTHESIS HAS ABNORMAL IRON LEVELS IN THE BLOOD. IT WOULD APPEAR THAT THE PATIENT HAS LIVER CANCER WHICH MAY BE RELATED TO THE PROSTHESIS. I DON'T HAVE ANY MORE INFORMATION AT THIS TIME."
Patient problems: Foreign Body Reaction; Metal Related Pathology
MAUDE report 15883230 ↗InjurySep 13, 2022Degraded; Detachment of Device or Device Component; Insufficient Device Problem Information; Degraded; Detachment of Device or Device Component; Insufficient Device Problem Information
DISTRIBUTOR REPORTED THAT "PATIENT REQUIRED A TOTAL REVISION OF RIGHT HIP."
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 15407932 ↗InjurySep 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
REVISION OF RIGHT SIDE THA COMPONENTS - ACCOLADE TMZF, 40MM STANDARD FEMORAL HEAD AND 40E ACETABULAR INSERT DUE TO DISLOCATION OF FEMORAL HEAD FROM STEM. REPLACED WITH 36E ACETABULAR INSERT, #9X 13MM RESTORATION HA STEM 155MM, 36 +10MM V40 FEMORAL HEAD. PRIOR TO SURGERY XRAY SHOWED FEMORAL HEAD WAS DISLOCATED FROM FEMORAL STEM. DURING SURGERY 40E INSERT FOUND TO BE CRACKED, FEMORAL STEM WAS REMOVED EASILY WITH NO APPARENT BONE IN GROWTH.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 15400223 ↗InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED A PRIMARY RIGHT HIP REPLACEMENT ON (B)(6) 2011. PATIENT REPORTS RIGHT HIP PAIN AND WOULD LIKE TO KNOW THE "METAL CONTENTS" OF IMPLANTED PARTS. PATIENT STATED HER DOCTOR HAS ORDERED BLOOD WORK TO DETERMINE IF ANY METAL IS FOUND IN HER BLOODSTREAM. PATIENT NOTED DOCTOR IS ALSO EXAMINING HER BACK TO SEE IF ANY BACK ISSUES ARE CONTRIBUTING TO HER HIP PAIN.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 14865385 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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.
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