LFIT 6260-9-440Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327032772), received between Jun 19, 2018 and Aug 25, 2023 — classified as 17 injuries.

The most frequently reported specific device problem is “Degraded” (7 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2023Degraded; Degraded

  THIS IS A CASE OF A HEAD IN THE LIST OF IMPLANTS THAT MAY BE MISALIGNED WITH V40. THE PATIENT WAS REVISED WITH ARMED SUSPICION. THE HEAD WAS REMOVED AND ALTHOUGH SOME CORROSION WAS OBSERVED, THERE WAS NO FRACTURE, SO THE HEAD AND INSERT WERE REPLACED. ALTHOUGH THE CAUSE CANNOT BE IDENTIFIED, THERE IS A HIGH POSSIBILITY THAT ARMED WAS CAUSED BY NECK TRANIOSIS FROM THE JOINT BETWEEN THE HEAD AND NECK. THE SURGERY WAS SUCCESSFULLY COMPLETED BY SCRAPING THE INSIDE OF THE JOINT AND REPLACING THE HEAD AND INSERT.

  Patient problems: Insufficient Information

  MAUDE report 17622360 ↗
• InjuryMay 19, 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) 2008, THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD AND A MERIDIAN TMZF HIP STEM. IT IS FURTHER ALLEGED THE PATIENT WAS REVISED ON (B)(6) 2021, AND THE SURGEON NOTED THAT THE HEAD WAS FOUND TO BE TOTALLY DISASSOCIATED FROM THE TRUNNION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16961009 ↗
• InjurySep 5, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ELEVATED CHROMIUM AND COBALT IONS. INTRA-OPERATIVELY, BLACK DEBRIS WAS NOTED AT THE JUNCTION OF THE WELL-FIXED HEAD AND STEM. THE STEM, HEAD AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, AND NEW LINER. REP PROVIDED AN X-RAY AND PICTURES AND CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER. REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction

  MAUDE report 15355287 ↗
• InjuryAug 29, 2022Unstable; Unstable

  RIGHT HIP REVISION FOR INSTABILITY. STEM, INSERT, AND HEAD WERE REVISED. PER RESPONSE: REMOVAL OF STEM WAS NOT PLANNED DURING REVISION IT WAS REMOVED HOWEVER AS A RESULT OF INTRA-OP EVENT, "WHEN THE CONSTRAINED INSERTS FAILED, STEM REMOVAL WAS NECESSARY".

  Patient problems: Joint Laxity

  MAUDE report 15316977 ↗
• InjuryMay 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISSOCIATION OF THE HEAD FROM THE STEM. THE STEM, HEAD AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14275958 ↗
• InjuryMar 29, 2022Corroded; Degraded; Corroded; Degraded

  AS REPORTED: "THE PATIENT CAME TO DR'S OFFICE COMPLAINING OF WORSENING HIP PAIN. AN MRI REVEALED A PSEUDO TUMOR AND THERE WERE ELEVATED CHROMIUM LEVELS. DURING SURGERY IT WAS NOTED THERE WAS SOME BLACKENING OF THE TRUNNION WITH LITTLE WEAR. A COMPETITOR STEM WAS USED AS THE REPLACEMENT STEM AFTER EXPLANTING THE WELL FIXED ACCOLADE." A STEM, HEAD, AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Cancer; Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 13938066 ↗
• InjuryApr 21, 2021Degraded; Material Erosion; Detachment of Device or Device Component; Insufficient Device Problem Information; Degraded; Material Erosion; 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) 2009 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: Metal Related Pathology; Unspecified Infection

  MAUDE report 11704559 ↗
• InjuryMar 26, 2021Degraded; Material Erosion; Adverse Event Without Identified Device or Use Problem; Degraded; Material Erosion; 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 HER RIGHT HIP ON OR ABOUT (B)(6) 2009 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT SHE 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 HER BLOOD. UPDATE: 11/07/2023: IN ADDITION TO TRUNNIONOSIS, PER MED REVIEW "OPERATIVE FINDINGS REVEALED EVIDENCE OF CORROSION AROUND THE HEAD WITH BLACK METAL IMPREGNATION OF THE SOFT TISSUES."

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 11573557 ↗
• InjuryFeb 9, 2021Degraded; 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) 2013 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. ADDITIONAL INFORMATION: COMPLETE DISASSOCIATION OF THE FEMORAL HEAD FROM THE FEMORAL STEM WITH ADVANCED TRUNNION WEAR. THE FEMORAL HEAD WAS STILL LOCATED WITHIN THE POLYETHYLENE SHELL OF THE ACETABULAR COMPONENT. THE TRUNNION OF THE FEMORAL STEM WAS VISUALIZED. IT WAS NOTED TO BE SEVERELY DEGRADED WITH THE TIP OF THE TRUNNION WORN DOWN TO A PENCIL TIP APPEARANCE.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 11301218 ↗
• InjuryDec 10, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED: "REVISION [RIGHT] TOTAL HIP DONE 11/17/20. LABS DONE FOR INFECTION AT TIME OF SURGERY WERE NEGATIVE. IMPLANTS CAN NOT BE RETRIEVED DUE TO HOSPITALS POLICY." REVISION DUE TO DISSOCIATION OF THE HEAD FROM THE STEM. LINER WEAR NOTED AROUND IT'S RIM. V40 HEAD, 0° POLY LINER, AND TMZF STEM WERE REVISED TO A 10° 36 MM ECCENTRIC LINER AND COMPETITOR FEMORAL COMPONENTS. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 10982471 ↗
• InjuryFeb 19, 2020Corroded; Degraded; Corroded; Degraded

  AS REPORTED: "LEFT THA REVISION SURGERY PERFORMED DUE TO PATIENT COMPLAINTS OF INCREASED PAIN. PER SURGEON LAB RESULTS SHOWED ELEVATED LEVELS OF COBALT. SURGEON STATED THAT PATIENT HAS BEEN DOING VERY WELL FOR SEVERAL YEARS POST INDEX PROCEDURE WITH RECENT LATE ONSET OF INCREASING PAIN. DURING REVISION SURGEON STATED FINDINGS OF TRUNNION CORROSION AND FEMORAL HEAD CORROSION. NO SIGNIFICANT SOFT TISSUE DAMAGE WAS NOTED. INERT AND HEAD EXCHANGE WAS PERFORMED."

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 9727813 ↗
• InjuryMay 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO TRUNNIONOSIS. INTRA-OPERATIVELY, EXCESSIVE TRUNNION WEAR, A MODERATE AMOUNT OF BLACK TISSUE IN THE PATIENT, AND LINER WEAR WERE NOTED. AN ACCOLADE TMZF PLUS STEM, LFIT V40 HEAD, AND 40F LINER WERE REVISED TO A RESTORATION MODULAR STEM, METAL HEAD, AND LINER. REP PROVIDED PRIMARY IMPLANT STICKERS AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8574972 ↗
• InjuryApr 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. LFIT V40 40+12MM HEAD, GMRS FEMORAL COMPONENT, AND TRIDENT 40E INSERT WERE REVISED TO LFIT 22.2+8MM V40 HEAD, GMRS-RT V40 FEMORAL COMPONENT, AND TRIDENT 22E INSERT.

  Patient problems: Injury

  MAUDE report 8547113 ↗
• InjuryMar 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION OF THE HEAD FROM THE STEM. SURGEON REPORTED PATIENT HAD METALLOSIS, AND EXCESSIVE BLACK TISSUE WAS NOTED IN THE PATIENT. A 40 +12 LFIT METAL HEAD AND LINER WERE REVISED TO A 28 +8 HEAD AND AN MDM/ADM LINER CONSTRUCT (THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER). THE STEM DID HAVE SOME TRUNNION WEAR, BUT NOT ENOUGH FOR THE SURGEON TO DECIDE TO REVISE IT, AND SO THE STEM REMAINS IMPLANTED. REP HAS AN EXPLANT PICTURE AND REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8386482 ↗
• InjuryJan 22, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  ITS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 THAT FAILED AND REQUIRED REVISION ON (B)(6) 2017 DUE TO ELEVATED LEVELS OF COBALT AND CHROMIUM REVEALED IN BLOOD WORK.

  Patient problems: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 8267673 ↗
• InjuryNov 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REMOVED A +12 THE 40 METAL HEAD AND X3 LINER AND REPLACED WITH A CERAMIC 7+5 HEAD AND ECCENTRIC LINER. IMPLANTS THAT WERE NOT EXPLANTED: 542-11-58G, LOT N3JMHE. 6021-0537, LOT 17095402. UPDATE 17/OCTOBER/2018: AS REPORTED IN HOW WAS ISSUE NOTICED: PATIENT PRESENTED WITH PAIN.

  Patient problems: Injury; Pain

  MAUDE report 8059788 ↗
• InjuryJun 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  NOTICE RECEIVED FROM PATIENT'S ATTORNEY ALLEGES THAT PATIENT HAD A STRYKER HIP PROSTHESIS WHICH WAS SUBJECT TO STRYKER'S RECALL. IT IS ALLEGED THAT THE PATIENT WOUND UP HAVING MANY OF THE SIGNS AND SYMPTOMS STRYKER SAID THE DEFECTIVE HIP WOULD CAUSE IN ITS RECALL NOTICE AND IN CONSULTATION WITH HIS ORTHOPAEDIC SURGEON HAS HAD A NUMBER OF PROCEDURES TO ADDRESS THE SIGNS AND SYMPTOMS HE WAS DISPLAYING, ULTIMATELY RESULTING IN THE PROSTHESIS BEING REMOVED.

  Patient problems: Injury

  MAUDE report 7614272 ↗