LFIT 6260-9-336Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 07613327032321), received between Jun 7, 2018 and May 27, 2026 — classified as 56 injuries.

The most frequently reported specific device problem is “Degraded” (20 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 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2010 AND WAS IMPLANTED WITH LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. THE LEFT HIP WAS REVISED ON (B)(6) /2025 DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 25306970 ↗
• InjuryMar 19, 2026Detachment of Device or Device Component

  PATIENT HAD EMERGENCY REVISION SURGERY DUE TO A HEAD DISASSOCIATION IN HIS RIGHT HIP. ON (B)(6) 2025, THE PATIENT REPORTED STANDING UP FROM A COUCH WHEN HE EXPERIENCED SEVERE PAIN AND WAS UNABLE TO WALK. PATIENT IS SEEKING COMPENSATION.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Pain

  MAUDE report 24636642 ↗
• InjuryAug 21, 2025Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  NO NEW INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22858563 ↗
• InjuryFeb 19, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 21415405 ↗
• InjuryJan 14, 2025Material Erosion; Detachment of Device or Device Component; 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 (B)(6) VIA MANDATORY HOSPITAL REPORTING: HEALTH CANADA REFERENCE #: (B)(4).

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21147961 ↗
• InjuryJan 14, 2025Degraded; Material Erosion; Degraded; 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 21147960 ↗
• InjuryDec 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2006 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE HIP STEM. HE WAS REVISED ON (B)(6) 2023 ALLEGEDLY DUE TO HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 20918210 ↗
• InjuryJul 26, 2024Material 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 BY THE CUSTOMER: "LOOSENING OF HEAD ON ACCOLADE I STEM." UPDATE FROM SURGEON: "THE PATIENT CONTACTED ER BECAUSE OF ACUTE PAIN IN THE RIGHT HIP AND HE WAS UNABLE TO WALK. X-RAY OF THE RIGHT HIP SHOWED DISLOCATION AND DISSOCIATION OF THE IMPLANT. THE PATIENT'S HIP WAS REVISED. SIGNIFICANT METALLOSIS AND WEAR OF THE TRUNNION WAS FOUND DURING SURGERY. THERE WAS NO IMPLANT LOOSENING. THE ACCOLADE TMZF STEM, HEAD AND LINER WERE SUCCESSFULLY REPLACED AT SURGERY. NO UNANTICIPATED MEDICAL INTERVENTION WAS NEEDED BESIDES REVISION SURGERY.

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

  MAUDE report 19844805 ↗
• InjuryJun 13, 2024Degraded; Detachment of Device or Device Component; Insufficient Device Problem Information; Degraded; Detachment of Device or Device Component; Insufficient Device Problem Information

  REP CALLED TO INFORM OF A BROKEN ACCOLADE TRUNNION IN A CASE OVER THE WEEKEND. THIS WAS A REVISION SURGERY. PRIMARY SURGERY WAS (B)(6) 2014.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Metal Related Pathology

  MAUDE report 19526548 ↗
• InjuryNov 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2008, AND WAS IMPLANTED WITH A ACCOLADE TMZF HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD. SHE WAS REVISED ON (B)(6) 2022, ALLEGEDLY DUE TO HEAD DISASSOCIATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 18098848 ↗
• InjuryNov 2, 2023Degraded; Degraded

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6), 2015, AND WAS IMPLANTED WITH A SECUR-FIT ADVANCED HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD. HE WAS REVISED ON (B)(6), 2021 ALLEGEDLY DUE TO PAIN, ELEVATED METAL ION LEVELS, AND METALLOSIS AT THE HEAD-TRUNNION INTERFACE.

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

  MAUDE report 18054158 ↗
• InjuryMay 11, 2023Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. PRE- AND INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: HEAD DISSOCIATION, TRUNNION WEAR, LINER WEAR. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH CERAMIC HEAD AND X-3 LINER.

  Patient problems: Pain

  MAUDE report 16910692 ↗
• InjuryMar 8, 2023Degraded; Degraded

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LEFT ANATOMIC COCR V40 FEMORAL HEAD ON HER LEFT HIP ON OR ABOUT (B)(6) 2014 AND WAS REVISED ON (B)(6) 2022. IT IS FURTHER ALLEGED THAT THE PATIENT HAD ELEVATED SERUM CHROMIUM AND COBALT LEVELS AND DUE TO WEAR OF THE TRUNNION SUFFERED A FRACTURE.

  Patient problems: Foreign Body Reaction

  MAUDE report 16503985 ↗
• InjuryDec 1, 2022Degraded; Material Erosion; Degraded; Material Erosion

  AS REPORTED: "RIGHT HIP REVISION DUE TO GROSS TRUNNION FAILURE." REP PROVIDED PRIOR USAGE AND AN EXPLANT PICTURE SHOWING TRUNNION WEAR. REP CONFIRMED THAT WHILE THE FEMORAL HEAD WAS EASILY REMOVED, IT WASN'T DISSOCIATED. REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 15893721 ↗
• InjuryJun 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "HIS HEAD AND LINER WERE REVISED TO A SLEEVE AND A BIOLOX HEAD DUE TO ALTR. THIS IS REVISION 1 FOR THIS HIP. NO IMPLANTS RETURNED PER HOSPITAL POLICY. NO FURTHER INFORMATION AVAILABLE TO HOSPITAL OR REP."

  Patient problems: Foreign Body Reaction

  MAUDE report 14849859 ↗
• InjuryJun 28, 2022Detachment 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 MPS: "I COVERED A HIP REVISION TODAY DUE TO TRUNNIONOSIS FAILURE IN THE RIGHT HIP W/ DISLOCATION (HEAD DISSOCIATION)." SPOKE TO MPS. A STEM, HEAD AND LINER WERE REVISED. EXPLANT PICTURE FOR THE LINER SHOWS DAMAGE ON THE RIM. THE MPS CANNOT CONFIRM IF THAT DAMAGE WAS PRESENT IN SITU OR IF IT IS EXPLANT DAMAGE.

  Patient problems: Insufficient Information

  MAUDE report 14839527 ↗
• InjuryJun 1, 2022Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component

  IT WAS REPORTED BY PATIENT'S ATTORNEY THAT ALLEGEDLY ON OR ABOUT (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP AND HAS HAD INCREASING PAIN AND ELEVATED COBALT AND CHROMIUM SERUM LEVELS. DURING THE REVISION SURGERY ON (B)(6) 2022, THE SURGEON NOTED THAT "THE FEMORAL HEAD CAME OFF THE TRUNNION SIMPLY BY PULLING ON IT BY HAND. THE TRUNNION WAS NOTED TO BE WORN OR PENCILED GROSSLY."

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

  MAUDE report 14566099 ↗
• InjuryApr 11, 2022Corroded; 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 HER RIGHT HIP AND WAS REVISED. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 14071201 ↗
• InjuryJan 11, 2022Corroded; Corroded

  STATUS POST THA 18 MONTHS PRIOR, PATIENT HAD PAIN, PSEUDOTUMOR, AND ELEVATED COBALT LEVELS. PRE OP DIAGNOSIS WAS TRUNNION CORROSION WITH A 36 +10 LFIT V40 HEAD. UPON REVISION OF THE HEAD AND LINER THE TRUNNION AND HEAD SHOWED MILD CORROSION. STEM WAS RETAINED. LINER AND HEAD WERE REPLACED WITH A 32 D ECCENTRIC LINER, V40 TO C-TAPER ADAPTER SLEEVE, AND A 32MM +5 C-TAPER CERAMIC HEAD.

  Patient problems: Cancer; Foreign Body Reaction; Pain

  MAUDE report 13222686 ↗
• InjuryJan 10, 2022Degraded; Degraded

  AS REPORTED: "RIGHT SIDE HIP REVISION, ALL COMPONENTS EXPLANTED WERE STRYKER COMPONENTS. THE PATIENT WAS RE-IMPLANTED WITH ALL NEW REVISION COMPONENTS, AND THE CASE SHEET IS ATTACHED. THE ORIGINAL SURGERY WAS DONE IN 2011, THE PATIENT RECENTLY WAS REPORTING PAIN IN HIS RIGHT HIP, X-RAYS SHOWED ECCENTRIC WEAR ON THE POLYETHYLENE COMPONENT, AS WELL AS THE FEMORAL HEAD ON THE TRUNNION. THE PATIENT¿S COBALT CHROME LEVELS WERE ELEVATED, SO THE SURGEON DECIDED TO REVISE THE HIP COMPONENT. ADVERSE LOCAL TISSUE REACTIONS WERE MINIMAL, HOWEVER THE FEMORAL HEAD DID HAVE CORROSION AND FRETTING WAS NOTED ON THE TRUNNION. A PORTION OF THE SUPERIOR LIP OF THE POLYETHYLENE LINER WAS FRACTURED OFF. THE LOCKING MECHANISM WAS INTACT ON THE POLYETHYLENE/ACETABULAR COMPONENT JUNCTION, AND THE LINER WAS NOT DISASSOCIATED FROM THE ACETABULAR COMPONENT. ALL COMPONENTS WERE REMOVED." UPDATE: THE SHELL WAS REVISED BECAUSE THE SURGEON DIDN¿T LIKE THE POSITION OF THE COMPONENT. THE DAMAGED PORTION OF THE LINER WAS THE PORTION THAT HAD THE LOT CODE ON IT THEREFORE IT WAS ILLEGIBLE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 13202843 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; 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 2006 AND WAS REVISED ON (B)(6) 2021. ALLEGEDLY THE FINDINGS DURING REVISION SURGERY WERE "THE FEMORAL STEM WAS IRREPARABLY DAMAGED AT THE TRUNNION WITH THE TRUNNION HAVING MELTED".

  Patient problems: Insufficient Information

  MAUDE report 12505155 ↗
• InjuryAug 16, 2021Degraded; Degraded

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ON (B)(6) 2009 THE PATIENT UNDERWENT A LEFT THA WITH AN ACCOLADE TMZF STEM AND LFIT V40 FEMORAL HEAD AND WAS REVISED ON (B)(6) 2019. THE REVISION OPERATIVE REPORT NOTED FRETTING CORROSION ON THE TAPER AND THE INSIDE OF THE FEMORAL HEAD AND PITTING OF THE TRUNNION.

  Patient problems: Insufficient Information

  MAUDE report 12329386 ↗
• InjuryAug 12, 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 HER RIGHT HIP ON OR ABOUT (B)(6) 2018 AND WAS REVISED ON (B)(6) 2020. 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.

  Patient problems: Insufficient Information

  MAUDE report 12314439 ↗
• InjuryJul 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON CALLED WITH A RECALL INQUIRY FOR A HEAD AND STEM. SURGEON REPORTED THE LATEST FOLLOW-UP VISIT INDICATES A PATIENT COMPLAINT OF BILATERAL TROCHANTERIC DISCOMFORT. PATIENT HAS NOT BEEN REVISED AT THE TIME OF REPORT.

  Patient problems: Discomfort

  MAUDE report 12157253 ↗
• InjuryJun 8, 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 HER LEFT HIP ON OR ABOUT (B)(6) 2010 AND WAS REVISED ON (B)(6) 2016. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Metal Related Pathology

  MAUDE report 11963206 ↗