LFIT 6260-9-236Recalls & reported problems
Howmedica Osteonics Corp. · V40 Femoral Head · Class 2 · Implant
Quick summary
This Howmedica LFIT femoral head is a ball that fits onto a hip stem. Its 253 reports often describe the head coming off the stem, worn or corroded metal, and metal-related tissue reactions, and several led to repeat surgery. The reports include 250 injuries and no deaths. Reports dropped from 26 in the previous 12 months to 7 in the most recent 12 months. 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
- 256
- Deaths reported
- 0
- Injuries reported
- 253
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 256 adverse event reports that list this exact device (DI 07613327032314), received between Nov 24, 2015 and Sep 16, 2026 — classified as 253 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (79 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
- Detachment of Device or Device Component79
- Device Dislodged or Dislocated78
- Insufficient Device Problem Information67
- Degraded56
- Material Erosion37
- Corroded29
- Adverse Event Without Identified Device or Use Problem17
- Mechanical Problem6
Patient problems
- Injury105
- Ambulation or Postural Difficulties63
- Metal Related Pathology55
- Inflammation53
- Reaction51
- Pain47
- Insufficient Information35
- Joint Dislocation30
Recent adverse event reports
The 25 most recent of 256 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Detachment of Device or Device Component
Patient problems: Joint Dislocation
MAUDE report 50794458 ↗InjurySep 16, 2026Detachment of Device or Device Component
Patient problems: Joint Dislocation
MAUDE report 50794454 ↗InjuryJul 30, 2026Degraded; Detachment of Device or Device Component
The following information was provided: It was reported that the patient's Left hip was revised due to extreme trunnion wear. The stem, head and liner were revised to an Insignia stem, ceramic head, and liner. Rep confirmed that there were no allegations against the revised liner. Rep also confirmed that aside from relevant pictures, no further information will be released by the hospital or surgeon.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 50091026 ↗InjuryMar 17, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: THE STEM WAS NOTCHED, THE TRUNNION WAS WORN, AND BLACK TISSUE WAS OBSERVED. THE STEM, HEAD, AND LINER WERE REVISED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER. REP CAN PROVIDE PICTURES, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology
MAUDE report 24616795 ↗InjuryFeb 24, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: (B)(6). SAID PATIENT CAME INTO URGENT CARE CLINIC COMPLAINING OF PAIN. (B)(6). SENT ME X-RAY FILMS TAKEN ON (B)(6) 2026 OF A PATIENT HE PERFORMED LEFT TOTAL HIP ARTHROPLASTY ON APPROXIMATELY 10 YEARS AGO. THE IMPLANTED FEMORAL HEAD WAS NOT ON THE STEM TRUNNION. THE STEM APPEARED TO BE AN ACCOLADE 2 AND THE HEAD APPEARED TO BE 36MM COCR. PATIENT WAS REFERRED TO UAMS FOR FURTHER TREATMENT AND POSSIBLE SURGERY. AS OF THIS MOMENT, PATIENT HAS NOT UNDERGONE ADDITIONAL SURGERY. THIS PATIENT HAS BEEN REFERRED TO ANOTHER CLINIC/SURGEON FOR FURTHER EVALUATION.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 24433621 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT REPORTED THAT HE ALLEGEDLY UNDERWENT RIGHT HIP REPLACEMENT SURGERY ON (B)(6) 2011, AND IN (B)(6) 2025 HE BEGAN EXPERIENCING CLICKING SOUNDS IN HIS RIGHT HIP. BLOOD TESTS WERE ORDERED AND RESULTS ALLEGEDLY SHOWED COBALT AT 17.5 AND CHROMIUM AT 6.1. ALLEGEDLY DURING THE REVISION SURGERY ON (B)(6) 2025, THE BALL COMPONENT WAS REPLACED WITH CLEANSING THE JOINT OF COBALT DEBRIS.
Patient problems: High metal ion levels; Metal Related Pathology
MAUDE report 24303038 ↗InjuryDec 12, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: THE SURGEON, ADVISED ME THAT HE WAS REVISING A STEM WITH A HEAD THAT DISASSOCIATED. RIGHT HIP. UPON THE CASE START, THE STEM APPEARS TO SHOW AN ACCOLADE TMZF STEM. A RESIDENT PULLED THE PATIENT'S CHART AND SAID THE STEM IS AN ACCOLADE TMZF SIZE 4.5 132° NECK ANGLE WITH A 58MM TRIDENT PSL CUP. THE INITIAL SURGERY WAS COMPLETED IN 2012. UPON ENTERING THE CAPSULE, DR STATED THAT THE TISSUE LOOKS BLACK WHICH IS USUALLY AN INDICATION FOR METALLOSIS. HE STATED THAT THE ACCOLADE TMZF STEM HAS TRUNNIONOSIS AND THAT'S WHY THE HEAD DISASSOCIATED. THE FEMORAL HEAD IS A LFIT 36MM +5. I DO NOT HAVE ACCESS TO THE STICKERS OF THESE IMPLANTS SHOWING LOT NUMBERS. I WILL COLLECT ANY IMPLANTS REMOVED TO SEND IN AS LONG AS THE PATIENT ISN'T REQUESTING TO KEEP THEM.
Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology
MAUDE report 23788970 ↗InjuryNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PATIENT, THROUGH COUNSEL, ALLEGES THAT HE UNDERWENT A LEFT THA ON (B)(6) 2008, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD. HE SUBSEQUENTLY WAS REVISED ON (B)(6) 2025, AND INTRAOPERATIVELY IT WAS NOTED THAT THE STEM TRUNNION HAD A PENCIL TIP DEFORMITY, AND THE HEAD BALL HAD FALLEN OFF COMPLETELY.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 23610404 ↗InjuryNov 12, 2025Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated; Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated
THE FOLLOWING INFORMATION WAS PROVIDED: A PATIENT WHO UNDERWENT THA (ACCOLADE TMZF) ON (B)(6) 2012. THE NECK TRUNNION OF THE ACCOLADE TMZF WORE OUT, CAUSING THE HEAD TO DISLOCATE FROM THE STEM WITHIN THE HIP JOINT, NECESSITATING REVISION ARTHROPLASTY ON (B)(6) 2025. DURING THE REVISION SURGERY, THE SURGEON OBSERVED METALLOSIS OF THE SURROUNDING TISSUES ASSOCIATED WITH STEM WEAR.
Patient problems: Ambulation or Postural Difficulties; Joint Dislocation
MAUDE report 23533797 ↗InjuryNov 5, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
NO NEW INFORMATION.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 23478910 ↗InjuryOct 22, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
PATIENT WHO UNDERWENT THA ON (B)(6) 2012. REOPERATION WAS REQUIRED DUE TO DEFORMATION OF THE STEM TRUNNION AND DISLODGED HEAD.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 23359003 ↗InjurySep 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
CLAIMANT, THROUGH COUNSEL, ALLEGES THAT HE UNDERWENT A RIGHT THA ON (B)(6) 2009 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD. HE SUBSEQUENTLY WAS REVISED ON (B)(6) 2025, DUE TO ALLEGED HEAD DISASSOCIATION.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 23031668 ↗InjurySep 4, 2025Degraded; Degraded
InjuryAug 6, 2025Degraded; Degraded
REP WAS NOTIFIED THAT A PATIENT'S RIGHT HIP IS TO BE REVISED DUE TO METALLOSIS. SURGEON INQUIRED IF THE FEMORAL HEAD IS IN SCOPE OF THE LFIT V40 RECALL (IT IS NOT). THE PLANNED REVISION WILL BE A HEAD/ LINER EXCHANGE. NO FURTHER INFORMATION IS AVAILABLE TO THE REP.
Patient problems: Foreign Body Reaction
MAUDE report 22733066 ↗InjuryJul 31, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
HEAD DISSOCIATED FROM TRUNNION - TRUNNION WAS WORN AND REPLACED WITH COMPETITOR. LINER WAS REPLACED WITH MDM LINER.
Patient problems: Insufficient Information
MAUDE report 22673838 ↗InjuryJul 28, 2025Degraded; Degraded
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY AFTER IMPLANTATION OF THE DEVICE THE PATIENT SUBSEQUENTLY BEGAN EXPERIENCING DISCOMFORT IN THE AREA OF THE DEVICE. IT IS ALLEGED THAT "DIAGNOSTIC WORKUP REVEALED THE PRESENCE OF MARKEDLY INCREASED LEVELS OF METAL IONS IN THE PATIENTS BLOOD AND/OR URINE." THE PATIENT CONTINUES TO EXPERIENCE ISSUES.
Patient problems: Foreign Body Reaction
MAUDE report 22636095 ↗InjuryApr 7, 2025Degraded; Material Erosion; Degraded; Material Erosion
InjuryMar 30, 2025Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP AND WAS REVISED ON (B)(6) 2024. IT IS FURTHER ALLEGED THAT THE TAPER HAD COMPLETELY CORRODED AND THE FEMORAL HEAD HAD FALLEN OFF INTO THE ACETABULUM.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 21728702 ↗InjuryMar 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2015 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE WAS REVISED ON (B)(6) 2024 DUE TO ALLEGED HEAD DISASSOCIATION.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 21708511 ↗InjuryFeb 10, 2025Detachment 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 RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PATIENT STARTED COMPLAINING A FEW MONTHS AGO ABOUT HER HIP FEELING ABNORMAL. X-RAYS REVEALED A PROBLEM WITH THE FEMORAL HEAD AND NECK COMBINATION. THE TRUNNION WAS WORN OFF. THE LINER WAS BASICALLY WORN AWAY." THE HEAD PARTIALLY CAME OFF THE TRUNNION BECAUSE OF THE WEAR.
Patient problems: Discomfort
MAUDE report 21342918 ↗InjuryFeb 6, 2025Insufficient 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 ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE WAS REVISED ON (B)(6) 2022 DUE TO ALLEGED SEVERE TRUNNION WEAR AND CONCERN FOR PSEUDOTUMOR.
Patient problems: Foreign Body Reaction
MAUDE report 21321410 ↗InjuryJan 14, 2025Material Erosion; Material Erosion
IT WAS REPORTED THAT ¿TRUNNIONOSIS OF HIP IMPLANT - RESULTING IN BROKEN IMPLANT NEEDING TO BE REVISED SURGICALLY¿. THIS EVENT WAS REPORTED TO STRYKER CANADA BY HEALTH CANADA VIA MANDATORY HOSPITAL REPORTING: HEALTH CANADA REFERENCE # (B)(4).
Patient problems: Insufficient Information
MAUDE report 21147965 ↗InjuryJan 14, 2025Material Erosion; Material Erosion
IT WAS REPORTED THAT ¿TRUNNIONOSIS OF HIP IMPLANT - RESULTING IN BROKEN IMPLANT NEEDING TO BE REVISED SURGICALLY¿. THIS EVENT WAS REPORTED TO STRYKER CANADA BY (B)(6) HOSPITAL REPORTING: HEALTH CANADA REFERENCE #: (B)(4).
Patient problems: Insufficient Information
MAUDE report 21147480 ↗InjuryJan 13, 2025Material Erosion; Material Erosion
IT WAS REPORTED THAT ¿TRUNNIONOSIS OF HIP IMPLANT - RESULTING IN BROKEN IMPLANT NEEDING TO BE REVISED SURGICALLY¿. THIS EVENT WAS REPORTED TO STRYKER CANADA BY HEALTH CANADA VIA MANDATORY HOSPITAL REPORTING: HEALTH CANADA REFERENCE #: (B)(4).
Patient problems: Insufficient Information
MAUDE report 21143396 ↗InjuryJan 13, 2025Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component
IT WAS REPORTED THAT ¿TRUNNIONOSIS OF HIP IMPLANT - RESULTING IN BROKEN IMPLANT NEEDING TO BE REVISED SURGICALLY¿. THIS EVENT WAS REPORTED TO STRYKER CANADA BY HEALTH CANADA VIA MANDATORY HOSPITAL REPORTING: HEALTH CANADA REFERENCE #: (B)(4).
Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Insufficient Information
MAUDE report 21143395 ↗
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
- 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
- ARTICUL/EZE 1365-22-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented220 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.