LFIT 6260-9-340Recalls & reported problems
Howmedica Osteonics Corp. · V40 Femoral Head · Class 2 · Implant
Quick summary
This Howmedica LFIT femoral head is the ball-shaped top of a hip implant that fits onto the metal stem. The 33 reports mostly describe the head coming loose or separating from the stem, wear at the junction, and metal debris in the body, along with pain, difficulty walking, and dislocation. All 33 reports describe injuries, and no deaths were reported. No recalls name this device. No reports were filed in the past 12 months, after 4 in the prior 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
- 33
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07613327032765), received between Aug 31, 2018 and Oct 27, 2025 — classified as 33 injuries.
The most frequently reported specific device problem is “Degraded” (13 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
- Degraded13
- Detachment of Device or Device Component12
- Device Dislodged or Dislocated10
- Insufficient Device Problem Information10
- Material Erosion5
- Adverse Event Without Identified Device or Use Problem3
- Corroded3
- Fracture1
Patient problems
- Injury16
- Ambulation or Postural Difficulties11
- Metal Related Pathology7
- Insufficient Information6
- Pain5
- Reaction5
- Foreign Body Reaction4
- Inflammation4
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 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 23392483 ↗InjuryMay 9, 2025Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO TRUNNION WEAR (REPORTED AS 'BIRD BEAKING'). THE STEM, HEAD, AND LINER WERE REVISED. THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Insufficient Information
MAUDE report 21991678 ↗InjuryFeb 6, 2025Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component
IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON DECEMBER (B)(6) 2013 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND #5 ACCOLADE TMZF STEM. ALLEGEDLY SHE DEVELOPED METALLOSIS ABOUT THE HIP AND HAS FRACTURED HER FEMORAL HEAD OFF OF THE TRUNNION. SHE WAS REVISED ON (B)(6) 2024.
Patient problems: Foreign Body Reaction; Metal Related Pathology
MAUDE report 21321405 ↗InjuryDec 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2015 AND WAS IMPLANTED WITH AN LFIT V40 ANATOMIC FEMORAL HEAD AND ACCOLADE II HIP STEM. HE WAS REVISED ON (B)(6) 2022 ALLEGEDLY DUE TO PAIN, DIFFICULTY WITH FUNCTION, AND ELEVATED COBALT AND CHROME ION LEVELS.
Patient problems: Metal Related Pathology; Pain
MAUDE report 20913553 ↗InjuryNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "THE REVISION WAS SECONDARY TO PAIN FROM DISLOCATION. THE DISLOCATION WAS IDENTIFIED RADIOGRAPHICALLY TO HAVE OCCURRED BETWEEN THE FEMORAL STEM AND FEMORAL HEAD. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL."
Patient problems: Ambulation or Postural Difficulties
MAUDE report 18062216 ↗InjuryMay 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT ALLEGEDLY ON (B)(6) 2012, THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD AND AN ACCOLADE TMZF HIP STEM. IT IS FURTHER ALLEGED THE PATIENT WAS REVISED ON (B)(6) 2022, DUE TO DISASSOCIATION OF THE FEMORAL HEAD FROM THE STEM.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 16972314 ↗InjuryFeb 14, 2022Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
AS REPORTED: "THE DOCTOR SAYS FEMORAL HEAD FELL OFF STEM. THE STEM TAPER WAS DAMAGED AND THE NECK OF THE STEM IS NOTCHED. " REVISION OF LEFT HIP, SIZE 5 ACCOLADE TMZF STEM AND 40 + 8MM COCR HEAD.
Patient problems: Insufficient Information
MAUDE report 13521924 ↗InjuryJan 25, 2022Degraded; 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 THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2021. 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 13340752 ↗InjuryNov 23, 2021Corroded; Degraded; Detachment of Device or Device Component; Insufficient Device Problem Information; Corroded; Degraded; Detachment of Device or Device Component; 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) 2007 AND WAS REVISED ON (B)(6) 2020. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICES AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. *UPDATE ON (B)(6) 2022 PER CLINICIAN REVIEW: "[...] AN OPERATIVE NOTE BY DR. DATED (B)(6) 2020 IS PROVIDED. THE PREOPERATIVE DIAGNOSIS WAS ¿MECHANICAL LOOSENING OF PROSTHETIC HIP¿ AND THE POSTOP DIAGNOSIS WAS THE SAME. THE OPERATION PERFORMED WAS A REVISION RIGHT TOTAL HIP ARTHROPLASTY. THE SURGEON USED A CEMENTLESS 70 MM SHELL, A POLYETHYLENE WITH A 28 MM INNER DIAMETER, A WAGNER SL FEMORAL STEM WAS UTILIZED, DEMINERALIZED BONE PUTTY, AND A 28 MM FEMORAL HEAD WAS UTILIZED. FEMORAL COMPONENT WAS GROSSLY LOOSE. THERE WAS NO EVIDENCE OF INFECTION. THE SURGEON DESCRIBES A HUGE AMOUNT OF OSTEOLYSIS WITH "AMORPHOUS SLUDGE TYPE OF WHITISH GRAY MATERIAL". HE STATES THAT THE FEMORAL HEAD WAS DISASSOCIATED FROM THE FEMORAL STEM AND THERE WAS A LARGE AMOUNT OF CORROSIVE BLACK TYPICAL MATERIAL ON BOTH TH
Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Metal Related Pathology; Osteolysis
MAUDE report 12860269 ↗InjuryAug 10, 2021Degraded; 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 HIS LEFT HIP ON OR ABOUT (B)(6), 2011 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. *UPDATE ON 05-MAY-2022 BASED ON CLINICIAN REVIEW: "[...] FOLLOWING ASSESSMENT THE REVISION OF AN LFIT V40 FEMORAL HEAD ON (B)(6) 2020 IS CONFIRMED. FINDINGS IN THE OPERATIVE REPORT FOR THIS SURGERY DESCRIBE GROSS METALLOSIS THROUGHOUT THE HIP AND A LARGE AMOUNT OF INFLAMMATORY TISSUE CONSISTENT WITH PSEUDOTUMOR. [...] "
Patient problems: Foreign Body Reaction; Insufficient Information; Metal Related Pathology
MAUDE report 12301698 ↗InjuryJun 15, 2021Corroded; 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) 2008 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: Ambulation or Postural Difficulties; Foreign Body Reaction
MAUDE report 11998979 ↗InjuryApr 9, 2021Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated; Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated
HEAD DISASSOCIATED FROM THE STEM.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 11645416 ↗InjuryApr 1, 2021Adverse 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 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) 2016 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.
Patient problems: Metal Related Pathology
MAUDE report 11602205 ↗InjuryMar 11, 2021Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
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) 2010 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. UPDATE: "HEAD DISASSOCIATION".
Patient problems: Insufficient Information
MAUDE report 11462027 ↗InjuryNov 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE SUBMISSION OF USAGE SHEET THAT THE PATIENT'S HIP WAS REVISED DUE TO INFECTION. A 40 MM LFIT V40 +8 MM HEAD WAS SWAPPED. FOR THE SAME TYPE AND SIZE. SPOKE TO REP, CONFIRMED OPERATIVE SIDE WAS LEFT. CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 10869550 ↗InjuryNov 13, 2020Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component
THA IMPLANT FAILURE AT THE NECK-HEAD JUNCTION. SEVERE ACCOLADE TAPER CORROSION AND BEFORE THE SURGERY CORROSION HAS CAUSED SEVERE PAIN. R REVISED THE STEM AND HEAD AND USED BIGGER ACCOLADE.
Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain
MAUDE report 10834911 ↗InjuryOct 1, 2020Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated
AS REPORTED: "PATIENT CAME TO OFFICE ON CRUTCHES. REVISED FEMORAL STEM. ACCOLADE PRIMARY STEM NECK FAILURE, TRUNNION. TRUNNION WORE AWAY. FEMORAL HEAD POPPED OFF. REVISION SURGERY TO RESTORATION MODULAR."
Patient problems: Ambulation or Postural Difficulties; Failure of Implant
MAUDE report 10617165 ↗InjuryAug 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN, AND ELEVATED ION LEVELS. AN LFIT V40 HEAD AND POLY LINER WERE REVISED. THE ACCOLADE TMZF STEM WAS RETAINED AS NO TRUNNION DAMAGE WAS NOTED, AND A CERAMIC HEAD WITH SLEEVE AND NEW LINER WERE IMPLANTED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP ALSO PROVIDED THE REVISION USAGE SHEET AND EXPLANT PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.
Patient problems: Inflammation; Injury; Pain; Reaction
MAUDE report 10452851 ↗InjuryAug 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WENT TO ER BECAUSE HE FELT A SNAP AND HIS HIP BECAME UNSTABLE. RADIOGRAPHS WERE TAKEN AND HIS HIP, RADIOGRAPHS REVEALED AN ISSUE WITH HEAD ALIGNMENT. THE PATIENT CONTACTED THE HUGHSTON CLINIC FOR AN EXAMINATION. THE DOCTOR SAW THE PATIENT AND IMMEDIATELY SCHEDULED HIM FOR A HIP REVISION THE FOLLOWING DAY. WE REVISED THE HEAD, STEM AND THE ACETABULUM POLY. PATIENT HAD HIS ACCOLADE TMZF STEM REVISED. A NEW HEAD AND A NEW LINER WAS IMPLANTED. THE TRIDENT CUP WAS NOT DAMAGED AND WAS DEEMED STABLE DURING THE SURGERY.
Patient problems: Injury
MAUDE report 10400552 ↗InjuryAug 11, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
THE PATIENT HAD A TOTAL HIP REPLACEMENT IN 2008, RECENTLY FELL AND SAW THE DOCTOR. THE X-RAYS REVEALED AN APPARENT FAILURE OF THE NECK OF THE FEMORAL STEM. THE DOCTOR ELECTED TO REVISE THE PROSTHESIS. SURGERY REVEALED THAT THE NECK OF THE FEMORAL STEM WAS BROKEN. THE ACETABULAR COMPONENT WAS RETAINED, THE ACETABULAR LINER WAS REVISED, THE FEMORAL STEM WAS REMOVED AND REVISED USING THE RESTORATION MODULAR SYSTEM.
Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Fall; Injury
MAUDE report 10390661 ↗InjuryJul 22, 2020Degraded; Detachment of Device or Device Component; Insufficient Device Problem Information; Degraded; Detachment of Device or Device Component; Insufficient Device Problem Information
AS REPORTED: "PRE-OP DIAGNOSIS: MECHANICAL COMPLICATION OF PROSTHETIC JOINT IMPLANT, INITIAL ENCOUNTER. MECHANICAL FAILURE OF LEFT HIP REPLACEMENT CONFIRMED BY DOCTOR INTRA-OP (HEAD-STEM JUNCTION). NO FURTHER INFORMATION AVAILABLE PER HOSPITAL."
Patient problems: Ambulation or Postural Difficulties; Injury
MAUDE report 10307935 ↗InjuryMay 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT FOLLOWING A HIP IMPLANT ON THE LEFT HIP THE PATIENT WAS NOT ABLE TO BEAR WEIGHT. IT WAS DISCOVERED UPON X RAY THAT THE HEAD OF THE STEM WAS BENT AND THE TRUNION DISPLAYED WEAR PATTERNS. BASED ON THIS INFORMATION THE LEFT HIP WAS REVISED.
Patient problems: Injury; Pain
MAUDE report 10048093 ↗InjuryApr 13, 2020Material Erosion; Material Erosion
PATIENT'S HIP WAS REVISED FOR FEMORAL TRUNNIONOSIS OF AN ACCOLADE II FEMORAL COMPONENT AND 40MM LFIT FEMORAL HEAD. LINER AND HEAD WERE REPLACED WITH A ECCENTRIC 36MM 0° LINER, +5 C-TAPER BIOLOX FEMORAL HEAD, AND V40 ADAPTER SLEEVE. UPDATE: "IT WAS A LEFT SIDE. THERE WERE NO ISSUES WITH THE LINER. CORROSION WAS NOTED ON THE TRUNNION AND HEAD. THE SURGEON DECLINED ANY FURTHER INFORMATION."
Patient problems: Injury
MAUDE report 9953767 ↗InjuryFeb 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED: "DISLOCATING LEFT TOTAL HIP. SWITCHED FEMORAL HEAD FROM +8 TO +12." SPOKE TO REP. THE FEMORAL HEAD DISLOCATED FROM A COMPETITOR LINER.
Patient problems: Ambulation or Postural Difficulties; Injury; Joint Dislocation
MAUDE report 9726793 ↗InjuryOct 31, 2019Corroded; Degraded; Corroded; Degraded
PATIENTS HIP WAS REVISED FOR INFECTION. UPON EXTRACTION OF THE ACCOLADE TMZF HIP STEM AND V40 LFIT HEAD, CORROSION WAS NOTED AROUND THE STEM TRUNNION.
Patient problems: Injury; Unspecified Infection
MAUDE report 9261692 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.