Accolade 6021-0230Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04546540510679), received between Jun 7, 2018 and Oct 22, 2025 — classified as 34 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Erosion; 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 23358859 ↗
• InjuryFeb 5, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21315303 ↗
• InjuryJul 9, 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 LEFT THA ON (B)(6) 2010, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2024, DUE TO ALLEGED HEAD DISSOCIATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19707629 ↗
• InjuryApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND AN ACCOLADE STEM. SHE UNDERWENT REVISION SURGERY ON (B)(6) 2023, DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19113199 ↗
• InjuryDec 14, 2023Material Erosion; Unstable; Material Erosion; Unstable

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD AND ACCOLADE TMZF PLUS HIP STEM ON HER RIGHT HIP ON OR ABOUT (B)(6) 2008. IT IS FURTHER ALLEGED THAT AFTER IMPLANTATION SHE EXPERIENCED PAIN AND SUFFERING AND LOSS MOBILITY AND REQUIRED A REVISION SURGERY.

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

  MAUDE report 18331993 ↗
• InjuryApr 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT REQUIRED A TOTAL HIP REVISION SURGERY DUE TO FAILURE OF THE HEAD-TRUNNION JUNCTION. THE PATIENT HAD PRESENTED TO THE ER WITH DISLOCATION OF THE FEMORAL HEAD WHICH WAS CONFIRMED UPON ADMITTANCE. IT WAS FURTHER REPORTED THAT THE REVISION INVOLVED REMOVAL OF THE TRIDENT ACETABULAR LINER, V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. THE ORIGINAL SHELL WAS LEFT IN PLACE.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 16712346 ↗
• InjuryOct 24, 2022Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  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) 2007 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 AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. UPDATE: IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON IMPLANTED DATE "(B)(6), 2007".

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 15657734 ↗
• InjuryOct 21, 2022Material Erosion; Material Erosion

  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), 2012 AND WAS REVISED ON (B)(6), 2022. 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: Foreign Body Reaction

  MAUDE report 15654959 ↗
• InjuryJun 28, 2022Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component

  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 14839526 ↗
• InjuryMar 24, 2022Adverse 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 HER RIGHT HIP ON OR ABOUT (B)(6) 2013 AND WAS REVISED ON (B)(6) 2020. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Metal Related Pathology

  MAUDE report 13878605 ↗
• InjuryJan 4, 2022Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  DISASSEMBLY OF THE PROSTHETIC IMPLANT ON (B)(6) 2021, WORN. OPERATED ON (B)(6) 2021. VERY SEVERE METALLOSIS WITH "PSEUDOTUMOR"; WEAR OF THE FEMORAL COLLAR. STEM AND HEAD EXPLANTED AND RE-IMPLANTATION OF NEW COMPONENTS.

  Patient problems: Metal Related Pathology

  MAUDE report 13153112 ↗
• InjurySep 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 LEFT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2021. INTRAOPERATIVELY THE FEMORAL HEAD FELL OFF OF THE FEMORAL STEM AND THERE WAS "SEVERE TRUNNIONOSIS OF THE FEMORAL STEM WITH SIGNIFICANT PENCILING OF THE FEMORAL NECK".

  Patient problems: Joint Dislocation

  MAUDE report 12497908 ↗
• InjuryJun 17, 2021Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO TRUNNION WEAR LEADING TO DISSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, IT WAS NOTED THAT THE WORN TRUNNION DUG INTO THE LINER. THE HEAD, LINER, AND STEM WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12018753 ↗
• InjuryMay 18, 2021Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  THE HEAD DISSOCIATED FROM THE STEM. ACCORDING TO THE IMAGE, IT SEEMS TO BE METALLOSIS. REVISION IS SCHEDULED ON (B)(6) 2021. PROBABLY DUE TO WEAR. SURGEON SUSPECTED THE PRODUCT ISSUE. *UPDATE ON 23 NOV 2021 PER CLINICIAN REVIEW: "A REVISION SURGERY WAS PERFORMED FOR SEVERE TRUNNIONOSIS AND HEAD STEM DISASSOCIATION. THERE WAS PSEUDOTUMOR, SEVERE METALLOSIS AND THE EXPLANT SHOWED SEVERE TRUNNION WEAR AND NOTCHING."

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

  MAUDE report 11840073 ↗
• InjuryMay 12, 2021Corroded; Degraded; Adverse Event Without Identified Device or Use Problem; Corroded; Degraded; 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) 2008 AND WAS REVISED ON (B)(6) 2019. 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: Insufficient Information; Metal Related Pathology

  MAUDE report 11810937 ↗
• InjuryFeb 18, 2021Material Erosion; Material Erosion

  REVISION OF ACCOLADE I WITH TRUNION WEAR.

  Patient problems: Insufficient Information

  MAUDE report 11343408 ↗
• InjuryFeb 2, 2021Degraded; Fracture; Detachment of Device or Device Component; Degraded; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT HAD THA IN 2008 AT ANOTHER FACILITY OUT OF TOWN. THE PATIENT PRESENTED WITH STEM FX AND PAIN AND XRAYS SHOWED FX AND SOME METAL ON METAL INDUCING PSEUDOTUMOR. THE PATIENT REQUIRED A REVISION OF THE FEMORAL STEM.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Pain

  MAUDE report 11269403 ↗
• InjuryDec 14, 2020Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  ITS ALLEGED BY THE ATTORNEY THROUGH THE FILING OF A LAWSUIT THAT THE PLAINTIFF UNDERWENT A RIGHT THA ON (B)(6) 2011. IT IS FURTHER ALLEGED THAT PLAINTIFF BEGAN EXPERIENCING DISCOMFORT AND PAIN IN THE AREA OF THE IMPLANTED DEVICE. BONE SCANS ORDERED ON (B)(6) 2017 DEMONSTRATED EVIDENCE OF LOOSENING IN THE HIS RIGHT HIP. THE PLAINTIFF HAS NOT BEEN REVISED.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration

  MAUDE report 11002355 ↗
• InjurySep 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT¿S REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005 THAT FAILED AND REQUIRED REVISION ON (B)(6) 2012 DUE TO ELEVATED LEVELS OF CHROMIUM AND COBALT REVEALED IN BLOOD WORK.

  Patient problems: Insufficient Information

  MAUDE report 10556435 ↗
• InjuryMay 19, 2020Material Erosion; Material Deformation; Material Erosion; Material Deformation

  IN 2013, THE PATIENT UNDERWENT THA PROCEDURE WITH MDM AND ACCOLADE TMZF. THEN, THE NECK OF THE STEM HAS SCRAPED DUE TO THE REAR IMPINGEMENT. ON (B)(6) 2020, THE REVISION SURGERY IS SCHEDULED. REQUEST: PLEASE IDENTIFY BASED ON YOUR INVESTIGATION WHAT IS LINE OF BETWEEN THE POLYETHYLENE AND THE NECK, WHICH IS ON THE NECKED PART OF THE COMPLAINT PRODUCT.

  Patient problems: Injury

  MAUDE report 10072619 ↗
• InjuryOct 4, 2019Adverse 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 RIGHT HIP ON OR ABOUT (B)(6) 2013 AND WAS REVISED ON (B)(6) 2018. 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: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 9156406 ↗
• InjurySep 24, 2019Degraded; Insufficient Device Problem Information; Degraded; 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 LEFT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

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

  MAUDE report 9112117 ↗
• InjuryAug 13, 2019Adverse 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 THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2007 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

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

  MAUDE report 8887645 ↗
• InjuryJul 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION HIP *UPDATED ON 26-AUG-2019 BY QS: BASED ON CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORD, THE RIGHT "STEM TRUNNION APPEARS DISASSOCIATED FROM THE HEAD".

  Patient problems: Injury

  MAUDE report 8827736 ↗
• InjuryJul 1, 2019Corroded; Mechanical Problem; Device Dislodged or Dislocated; Corroded; Mechanical Problem; Device Dislodged or Dislocated

  AS REPORTED BY REP: "DOCTOR HAD A TRANSFERRED PATIENT COME IN ON HIS SERVICE WITH A LEFT LEG WITH A FEMORAL HEAD DISASSOCIATION. THE PATIENT WAS SCHEDULED FOR SURGERY. THE DOCTOR'S PLAN WAS TO REMOVE THE STEM, HEAD AND POLY AND HOPE TO LEAVE A WELL-FIXED CUP. WHEN THE DOCTOR OPENED HE NOTED METALLOSIS. HE REMOVED THE ORIGINAL ACCOLADE TMZF, LFIT HEAD AND POLY. HE DEBRIDED AND LAVAGED THE AREA AS WELL". PATIENT WAS REVISED TO COMPETITOR STEM, HEAD, AND A STRYKER LINER. REP PROVIDED A PRE-REVISION X-RAY AND A SALES ORDER FROM THE PRIMARY PROCEDURE. REP REPORTED HE CAN OBTAIN OPERATIVE REPORTS, AND THE EXPLANTS FOR RETURN.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8747860 ↗