LFIT 6260-9-136Recalls & reported problems

Summary

The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 07613327032307), received between Jun 19, 2018 and Sep 24, 2026 — classified as 165 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (58 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 166 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Material Erosion

  The following information was provided: It was reported through the filing of a lawsuit that allegedly the patient underwent right THA on November 14, 2013, and was implanted with an LFIT V40 femoral head. It is alleged he developed increasing hip pain, elevated cobalt levels, MRI findings demonstrating a fluid collection and possible pseudotumor and findings concerning for metallosis. He was revised on June 21, 2024.

  Patient problems: Foreign Body Reaction

  MAUDE report 50880647 ↗
• InjurySep 2, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50573349 ↗
• InjuryAug 31, 2026Degraded

  It was reported that the patient's right hip was revised after patient complaint of pain. Intra-operatively, the following was reported: There was a moderate amount of black tissue removed. Operating room staff remarked that the liner appeared more yellow than expected. The stem, though well-fixed, had corrosion on the trunnion. The trunnion was cleaned off, and the well-fixed stem and shell remained in situ. Rep confirmed that no further information will be released by the hospital or surgeon.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 50516762 ↗
• InjuryMay 28, 2026Material Erosion

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2015 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM WHICH WAS REVISED ON (B)(6) 2025 DUE TO ALLEGED PSEUDOTUMOR AND TRUNNIONOSIS.

  Patient problems: Insufficient Information

  MAUDE report 25315694 ↗
• InjuryMay 28, 2026Material Erosion

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2016 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM WHICH WAS REVISED ON (B)(6) 2025 DUE TO ALLEGED PAIN AND SIGNS OF METALLOSIS.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 25315367 ↗
• InjuryMay 28, 2026Material Erosion

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2014 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM WHICH WAS REVISED ON (B)(6) 2024 DUE TO INCREASING PAIN, ELEVATED COBALT AND CHROMIUM LEVELS AND ALTR.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 25315225 ↗
• 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 THA ON (B)(6) 2012 AND WAS IMPLANTED WITH LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM THAT WAS SUBSEQUENTLY REVISED ON (B)(6) 2023 DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 25306923 ↗
• 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 THA ON (B)(6) 2011 AND WAS IMPLANTED WITH LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. THE RIGHT HIP WAS REVISED ON (B)(6) 2024 DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 25304293 ↗
• InjuryMar 4, 2026Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2008 AND WAS IMPLANTED WITH LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. THE RIGHT HIP WAS REVISED ON (B)(6) 2024 DUE TO ALLEGED HEAD DISSOCIATION

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 24505229 ↗
• InjuryMar 3, 2026Degraded

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2017 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD WHICH WAS REVISED ON (B)(6) 2024 DUE TO ALLEGED ELEVATED METAL IONS AND METALLOSIS.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 24494535 ↗
• InjuryFeb 25, 2026Material Erosion

  THE FOLLOWING INFORMATION WAS PROVIDED: METALLOSIS OF PRIOR STRYKER THA FROM 2023 LEADING TO COMPROMISED SOFT TISSUES AND STABILITY. METAL HEAD (CAT 62609136 AND LOT HN6J35) AND LINER WERE REMOVED AND REPLACED WITH A UNIVERSAL SLEEVE WITH A 28 CERAMIC UNIVERSAL HEAD AND A CONSTRAINED LINER. THE ACCOLADE STEM IMPLANTED IN 2023 AND LEFT IN THERE IS CAT 67210435 AND LOT 71540802

  Patient problems: Foreign Body Reaction

  MAUDE report 24443310 ↗
• InjuryJun 9, 2025Degraded; Degraded

  NO NEW INFORMATION.

  Patient problems: Fall; Metal Related Pathology

  MAUDE report 22165319 ↗
• InjuryMar 3, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT HIP REVISION OF AN ABG SIZE 7 MODULAR STEM, 36 + COBALT CHROME HEAD DUE TO METALLOSIS. THE SURGEON REVISED THE STEM AND HEAD.

  Patient problems: Foreign Body Reaction

  MAUDE report 21503578 ↗
• InjuryFeb 6, 2025Material Erosion; Material Erosion

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2021 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE II STEM. HE WAS REVISED ON (B)(6) 2023 DUE TO ALLEGED METALLOSIS.

  Patient problems: Foreign Body Reaction

  MAUDE report 21321411 ↗
• InjuryJan 15, 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 21160990 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2013, AND WAS IMPLANTED WITH A LFIT COCR FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HE WAS REVISED ON (B)(6) 2024 WITH A POSTOPERATIVE DIAGNOSIS OF "SEVERE TENDINOSIS/METALLOSIS WITH A SEVERELY DAMAGED TRUNNION OF THE FEMORAL STEM AS WELL AS SIGNIFICANT DAMAGE TO THE POLYETHYLENE LINER IN THE ACETABULUM".

  Patient problems: Insufficient Information

  MAUDE report 20651096 ↗
• InjuryNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  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 TMZF HIP STEM. HE WAS REVISED ON (B)(6) 2024, DUE TO ALLEGED FEMORAL HEAD DISSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 20623450 ↗
• InjuryOct 18, 2024Material Erosion; Device Dislodged or Dislocated; Material Erosion; Device Dislodged or Dislocated

  DR SCHEDULED A REVISION THA SECONDARY TO A PATIENT HAVING MULTIPLE DISLOCATIONS. THE INDEX PROCEDURE WAS BELIEVED TO HAVE BEEN DONE AROUND 2006. EXPOSURE OF THE JOINT REVEALED SIGNIFICANT METALLOSIS AND TRUNNION DAMAGE. DR DECIDED TO REPLACE THE POLYETHYLENE LINER, REMOVE THE STEM AND IMPLANTED A COMPETITOR HIP STEM.

  Patient problems: Joint Dislocation

  MAUDE report 20479171 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN/ JOINT DISCOMFORT. THE SURGEON HAD A CONCERN THAT THERE MAY BE A SOFT TISSUE REACTION. HOWEVER, INTRA-OPERATIVELY NOTHING OF NOTE WAS FOUND IN THE PATIENT'S SOFT TISSUE, IMPLANTS WERE NOTED TO BE WELL-FIXED, AND THERE WAS NO WEAR AT THE HEAD/ TRUNNION INTERFACE. AN LFIT HEAD WAS REVISED TO A CERAMIC HEAD.

  Patient problems: Pain

  MAUDE report 20285814 ↗
• InjurySep 6, 2024Corroded; Corroded

  AS REPORTED BY CUSTOMERS SOLICITOR: ON OR AROUND (B)(6) 2008 THE CLAIMANT UNDERWENT A LEFT HIP REPLACEMENT WITH A FOLLOW UP OPERATION ON OR AROUND THE (B)(6) 2009. IT IS SUBMITTED THAT THE IMPLANTS SUPPLIED WERE DEFECTIVE AND DUE TO THE SAME THE CLAIMANT'S HIP BECAME INFECTED SUBJECTING THE CLAIMANT TO WORSENING HIP PAIN FROM (B)(6) 2023 ONWARDS. FOLLOWING INVESTIGATIONS IT WAS DISCOVERED THAT CORROSION OF THE IMPLANTS WAS THE CAUSE OF THE ONGOING INFECTION/SYMPTOMS NECESSITATING THE REMOVAL AND REPLACEMENT OF THE DEFECTIVE IMPLANTS. THIS REVISION SURGERY TOOK PLACE IN (B)(6) 2023.

  Patient problems: Bacterial Infection; Pain; Unspecified Infection

  MAUDE report 20155371 ↗
• InjuryAug 31, 2024Material Erosion; Material Erosion

  HIP STEM AND HEAD REVISED DUE TO IMPLANT FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 20114672 ↗
• InjuryAug 8, 2024Corroded; Corroded

  PATIENTS LEFT HIP WAS REVISED FOR CUP MALPOSITIONING AND FLUID COLLECTION AROUND THE JOINT. UPON REMOVAL OF THE FEMORAL HEAD FROM THE STEM THERE WAS CONSIDERABLE CORROSION OF THE TRUNNION VISIBLE. A NEW CUP WAS POSITIONED IN THE ACETABULUM TO ELIMINATE FEMORAL COMPONENT IMPINGEMENT. THE CORROSION WAS CLEANED FROM THE STEM TRUNNION AND A V-40 TO C-TAPER ADAPTER SLEEVE WAS USED TO IMPLANT A C-TAPER CERAMIC HEAD WITH A MDM LINER.

  Patient problems: Insufficient Information

  MAUDE report 19939947 ↗
• InjuryJul 22, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2007 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE STEM REQUIRING REVISION SURGERY ON (B)(6) 2024, DUE TO ALLEGED BROKEN TRUNNION. THE SURGEON ¿ENCOUNTERED DARK JOINT FLUID AND HEAVILY PIGMENTED TISSUE CONSISTENT WITH METALLOSIS".

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology

  MAUDE report 19800333 ↗
• InjuryJul 2, 2024Material Erosion; Material Erosion

  THE PATIENT UNDERWENT A LEFT THA ON (B)(6) 2008, AND WAS REVISED ON 12/12/2018 DUE TO ALLEGED ELEVATED SERUM COBALT LEVELS AND CORROSION.

  Patient problems: Metal Related Pathology

  MAUDE report 19656296 ↗
• InjuryJun 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2013, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 19488058 ↗