LFIT 6260-9-244Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327032758), received between Aug 9, 2018 and Sep 12, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Degraded; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PT. CALLED AND REPORTED THAT THEY HAVE A RECALLED HIP AND HAVE TO HAVE IT REPLACED. IT'S OSTEONICS ACCOLADE SYSTEM AND IT WAS DONE (B)(6) 2013. INSURANCE CALLED AND SAID THAT HIP WAS RECALLED. I'VE REALLY SUFFERED. THE PAIN IS REALLY BAD AND CAN HARDLY WALK. PENDING REVISION. UPDATE: PT. WAS REVISED ON (B)(6) 2024.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology; Pain

  MAUDE report 20199652 ↗
• InjurySep 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY PATIENT'S ATTORNEY 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) 2021. IT IS FURTHER ALLEGED THAT DURING THE REVISION THE FEMORAL NECK WAS NOTED TO HAVE A PENCIL TIP APPEARANCE AND THERE WAS INTRA PROSTHETIC DISLOCATION OF THE FEMORAL HEAD FROM TRUNNION.

  Patient problems: Insufficient Information

  MAUDE report 17697769 ↗
• InjuryNov 16, 2022Degraded; Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated; Degraded; Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO TRUNNION WEAR AND HEAD DISSOCIATION. INTRA-OPERATIVELY, IT WAS DISCOVERED THE TRUNNION DUG THROUGH THE LINER AND WAS ARTICULATING AGAINST THE SHELL, CAUSING ADDITIONAL WEAR. METALLOSIS WAS ALSO NOTED. THE STEM, HEAD, AND LINER WERE REVISED. REP CAN PROVIDE PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 15803532 ↗
• InjuryMar 26, 2021Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO STEM FAILURE. INTRAOPERATIVELY, TRUNNION WEAR, METALLOSIS, HEAD TOGGLING ON TRUNNION, BLACK TISSUE, AND A BROKEN INSERT WERE NOTED. A 44 MM +4 V40 HEAD, TMZF PLUS STEM, AND 0° 44F INSERT WERE REVISED. REP CONFIRMED THAT ASIDE FROM PROVIDED PRIMARY USAGE SHEET, NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 11574194 ↗
• InjuryDec 14, 2020Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated; Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, BLACK TISSUE AND FLUID WAS NOTICED, AS WELL AS THE TRUNNION HAVING BEEN WORN DOWN TO A POINT. THE STEM, HEAD AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, ADM/ MDM POLY INSERT, AND MDM METAL LINER.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Inflammation; Metal Related Pathology

  MAUDE report 11001128 ↗
• InjurySep 7, 2020Material Erosion; Device Dislodged or Dislocated; Material Erosion; Device Dislodged or Dislocated

  PATIENT CAME TO CLEVELAND CLINIC COMPLAINING OF PROGRESSIVE HIP PAIN. AN X-RAY REVEALED A DISASSOCIATED FEMORAL HEAD DUE TO EXCESSIVE TRUNION WEAR OF THE FEMORAL STEM. DURING SURGERY WAS NOTED THE TRUNION HAD WORN TO THE POINT THAT THE FEMORAL HEAD HAD CAME OFF. AFTER EXPLANTING THE ACCOLADE TMZF STEM A RESTORATION MODULAR STEM WAS USED AS THE REPLACEMENT DEVICE.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Metal Related Pathology; Pain

  MAUDE report 10499267 ↗
• InjuryDec 30, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AFTER PATIENT COMPLAINT OF PAIN, DIAGNOSTICS REVEALED ELEVATED SERUM ION LEVELS IN THE PATIENT'S BLOOD. INTRA-OPERATIVELY, SOME CORROSION WAS NOTED INSIDE THE FEMORAL HEAD. THE FEMORAL HEAD WAS REVISED TO A SLEEVE WITH CERAMIC HEAD. THE STEM WAS NOT REVISED AS THE TRUNNION WAS INTACT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Pain; Reaction

  MAUDE report 9532017 ↗
• InjuryJul 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO EXTREME WEAR OF THE TRUNNION AND DISASSOCIATION. INTRA-OPERATIVELY, AN EXCESSIVE AMOUNT OF BLACK TISSUE WAS NOTED IN THE PATIENT. THE STEM, HEAD, AND POLY LINER WERE REVISED (REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE LINER). REP PROVIDED A PICTURE OF THE EXPLANTS AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Reaction

  MAUDE report 8785998 ↗
• InjuryJan 11, 2019Corroded; Device Dislodged or Dislocated; Corroded; Device Dislodged or Dislocated

  END USER HAS REPORTED THAT THERE WAS SEVERE ACCOLADE TAPER CORROSION FOR THE PATIENT. THEY REVISED THE STEM AND USED CONE CONICAL AS A REVISION STEM. THEY'VE NOTICED THE MENTIONED PROBLEM FROM THE PATIENT'S X RAY AND DURING THE SURGERY THEY NOTICED THE ACTUAL IMPLANT WITH THE PROBLEM.

  Patient problems: Injury

  MAUDE report 8239616 ↗
• InjuryAug 9, 2018Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF THE FAILED LEFT HIP. STEM, LINER, HEAD REVISED AND CUP WAS RETAINED. UPDATE AS PER MEDICAL REVIEW STATED " ... ON (B)(6) 2015 A HISTORY AND PHYSICAL STATES, " PAIN IN THE HIP AND HAS ELEVATED COBALT AND CHROMIUM FROM A RECALLED STRYKER HIP IMPLANT". ON (B)(6) 2015 A REVISION OF THE LEFT TOTAL HIP ARTHROPLASTY, FEMUR, AND ACETABULAR SCREWS AND LINER, AND ABDUCTOR TENDON REPAIR WAS PERFORMED FOR A DIAGNOSIS OF "FAILED LEFT THA WITH METALLOSIS AND ABDUCTOR TENDON DISRUPTION". THE OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA AND NOTES, "PAIN IN THE SETTING OF A RECALLED COMPONENT". THE FINDINGS AT SURGERY WERE , "NO SIGNIFICANT OSTEOLYSIS ... AVULSION OF ABDUCTOR OFF GREATER TROCHANTER ... VISIBLE METALLOSIS ... MORSE TAPER/TRUNNION JUNCTION WITH METAL DEBRIS WITHIN HEAD AND AROUND THE BASE OF THE TRUNNION"."

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 7769741 ↗