Accolade 6020-3535Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04546540510624), received between Apr 6, 2018 and Feb 10, 2025 — classified as 21 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2025Degraded; Fracture; Detachment of Device or Device Component; Degraded; Fracture; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED: "THE PATIENT BENT OVER AND IT CRACKED IN HIS LEFT HIP. YOU CAN SEE THE BROKEN CONE." UPDATE: PROPOSED REVISION DATE IS SET FOR (B)(6) 2025. UPDATE: THE CUSTOMER TOLD ME THAT THE NECK IS NOT BROKEN. THE METAL SHOWS A HIGH DEGREE OF ABRASION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21343414 ↗
• InjuryNov 20, 2024Material Erosion; Loss of Osseointegration; Device Dislodged or Dislocated; Material Erosion; Loss of Osseointegration; Device Dislodged or Dislocated

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT ACETABULAR REVISION ON (B)(6)2012 AND WAS IMPLANTED WITH AN LFIT V40 COCR FEMORAL HEAD AND COMPETITOR SYSTEM. HE WAS REVISED ON (B)(6) 2021 WITH A PRE AND POST OPERATIVE DIAGNOSIS OF "MECHANICAL COMPLICATION RIGHT HIP STATUS POST RIGHT TOTAL HIP ARTHROPLASTY REVISION WITH ELEVATED COBALT AND CHROMIUM IONS AND LOOSE RIGHT FEMORAL STEM".

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 20741619 ↗
• InjuryNov 20, 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) 2014, AND WAS IMPLANTED WITH A LFIT COCR FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HE WAS REVISED ON (B)(6) 2023, DUE TO ALLEGED FEMORAL HEAD DISSOCIATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20741615 ↗
• InjuryMar 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED DISSOCIATION OF THE FEMORAL HEAD FROM THE TRUNNION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 18997171 ↗
• InjuryNov 2, 2023Material Erosion; Material Erosion

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2009, AND WAS IMPLANTED WITH A ACCOLADE TMZF HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD. HE WAS REVISED ON (B)(6) 2021, ALLEGEDLY DUE TO TRUNNIONOSIS.

  Patient problems: Metal Related Pathology

  MAUDE report 18054066 ↗
• InjuryJun 6, 2023Degraded; Adverse Event Without Identified Device or Use Problem; 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 HER RIGHT HIP ON OR ABOUT (B)(6) 2016 AND WAS REVISED ON (B)(6) 2021. 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; Muscle/Tendon Damage; Osteolysis; Pain

  MAUDE report 17076242 ↗
• 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) 2012, THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD AND AN ACCOLADE TMZF HIP STEM. IT IS FURTHER ALLEGED THE PATIENT WAS REVISED ON (B)(6) 2022, DUE TO DISASSOCIATION OF THE FEMORAL HEAD FROM THE STEM.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16961098 ↗
• InjuryOct 12, 2022Degraded; Fracture; Detachment of Device or Device Component; Degraded; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT'S HIP WAS REVISED DUE TO FAILURE OF THE FEMORAL NECK (REP CLARIFIED THE TRUNNION LOOKED GROUND DOWN AND THERE WAS A NOTCH IN THE NECK). 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 15585388 ↗
• InjuryJul 19, 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 ON (B)(6) 2009 THE PATIENT UNDERWENT RIGHT HIP REPLACEMENT AND IN OR AROUND (B)(6) 2012 HE BEGAN TO EXPERIENCE PAIN IN HIS RIGHT HIP. IT IS ALLEGED THE PATIENT SUFFERED INJURIES INCLUDING IMMOBILITY, PAIN, INFLAMMATION, SWELLING, SCARRING, PSEUDO-TUMORS AND OTHER ADVERSE EFFECTS ASSOCIATED WITH THE IMPLANTS AND IS UNABLE TO HAVE SURGERY TO REMOVE AND REPLACE THE IMPLANTS DUE TO HIS AGE.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Pain; Swelling/ Edema

  MAUDE report 15050856 ↗
• InjuryJun 30, 2022Corroded; Detachment of Device or Device Component; Device Dislodged or Dislocated; Corroded; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED: "PATIENT ARRIVED AT HOSPITAL WITH A DISLOCATED HIP [FEMORAL HEAD DISSOCIATION]STEM WAS REMOVED TRUNNION CORROSION AND FAILURE IN MONOLITHIC METAL WAS OBSERVED. AN ACCOLADE 2 STEM WAS IMPLANTED WITH NEW LINER AND +5MM 36MM CERAMIC HEAD. NO OTHER PARTS WERE REMOVED OR REVISED." REP PROVIDED EXPLANT PICTURES AND X-RAYS. SPOKE TO REP. INTRA-OPERATIVELY, DAMAGE TO THE RIM OF THE LINER WAS ALSO NOTED.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 14874625 ↗
• InjuryJun 14, 2021Degraded; Adverse Event Without Identified Device or Use Problem; 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) 2011 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: Insufficient Information; Metal Related Pathology

  MAUDE report 11996706 ↗
• InjuryJun 2, 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) 2013 AND WAS REVISED ON (B)(6) 2021. 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: Insufficient Information

  MAUDE report 11918453 ↗
• InjuryOct 1, 2020Material Erosion; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Erosion; Detachment of Device or Device Component; Insufficient Device Problem Information

  AS REPORTED: "PATIENT CAME TO OFFICE ON CRUTCHES. REVISED FEMORAL STEM. ACCOLADE PRIMARY STEM NECK FAILURE, TRUNNION. TRUNNION WORE AWAY. FEMORAL HEAD POPPED OFF. REVISION SURGERY TO RESTORATION MODULAR."

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant

  MAUDE report 10616615 ↗
• InjuryAug 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  NOTIFIED OF FAILED TRUNION BY SURGEON ON JULY 26 2020, REVISION SURGERY PLANNED AND EXECUTED ON (B)(6) 2020, TRUNION ON STEM WORN BY METAL HEAD. METALLOSIS IDENTIFIED ON ENTRY INTO THE CAPSULE.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 10434969 ↗
• InjuryMar 12, 2020Material Erosion; Fracture; Insufficient Device Problem Information; Material Erosion; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT FOLLOWING A HIP IMPLANT ON THE LEFT HIP THE PATIENT WAS NOT ABLE TO BEAR WEIGHT. IT WAS DISCOVERED UPON X RAY THAT THE HEAD OF THE STEM WAS BENT AND THE TRUNION DISPLAYED WEAR PATTERNS. BASED ON THIS INFORMATION THE LEFT HIP WAS REVISED.

  Patient problems: Injury; Pain

  MAUDE report 9822895 ↗
• InjuryFeb 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR REVISION OF RIGHT HIP. PATIENT CALLED STATING SHE HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2009. PATIENT IS GETTING REVISED ON (B)(6) 2018 DUE TO ELEVATED COBALT IN HER BLOOD.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9752266 ↗
• InjuryDec 2, 2019Degraded; Material Separation; Naturally Worn; Degraded; Material Separation; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION OF THE FEMORAL HEAD FROM THE STEM. INTRA- OPERATIVELY, EXCESSIVE TRUNNION WEAR AND LINER WEAR WERE NOTED. THE STEM, HEAD AND LINER WERE REVISED. REP HAS SOME ADDITIONAL PICTURES, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 9394592 ↗
• 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 8785999 ↗
• InjuryApr 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CALLED STATING HE HAD A RIGHT HIP REPLACEMENT DONE ON (B)(6) 2009. PATIENT REPORTED PAIN, INFLAMMATION AND ELEVATED LEVELS OF COBALT AND CHROMIUM. HE WANTS TO KNOW IF HIS IMPLANTS WERE INVOLVED IN A RECALL.

  Patient problems: Inflammation; Pain; Reaction

  MAUDE report 8541764 ↗
• InjuryOct 4, 2018Insufficient Device Problem Information; 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) 2010 AND WAS REVISED ON (B)(6) 2011. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL, EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HIS BLOOD.

  Patient problems: Injury; Reaction

  MAUDE report 7935205 ↗
• InjuryApr 6, 2018Degraded; 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) 2009 AND WAS REVISED ON (B)(6) 2017. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

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

  MAUDE report 7403646 ↗