Accolade 6021-0537Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04546540510709), received between Jun 15, 2018 and Feb 24, 2026 — classified as 46 injuries.

The most frequently reported specific device problem is “Degraded” (13 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Degraded; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: DR. SAID PATIENT CAME INTO URGENT CARE CLINIC COMPLAINING OF PAIN. DR. SENT ME X-RAY FILMS TAKEN ON (B)(6) 2026 OF A PATIENT HE PERFORMED LEFT TOTAL HIP ARTHROPLASTY ON APPROXIMATELY 10 YEARS AGO. THE IMPLANTED FEMORAL HEAD WAS NOT ON THE STEM TRUNNION. THE STEM APPEARED TO BE AN ACCOLADE 2 AND THE HEAD APPEARED TO BE 36MM COCR. PATIENT WAS REFERRED TO UAMS FOR FURTHER TREATMENT AND POSSIBLE SURGERY. AS OF THIS MOMENT, PATIENT HAS NOT UNDERGONE ADDITIONAL SURGERY. THIS PATIENT HAS BEEN REFERRED TO ANOTHER CLINIC/SURGEON FOR FURTHER EVALUATION.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 24433622 ↗
• InjuryNov 3, 2025Degraded; Degraded

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. INTRA-OPERATIVELY, TRUNNIONOSIS WAS OBSERVED. THE STEM AND HEAD WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 23451400 ↗
• InjuryMay 7, 2025Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO TRUNNION WEAR (REPORTED AS 'BIRD BEAKING'). THE STEM, HEAD, AND LINER WERE REVISED. THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 21974927 ↗
• InjuryDec 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, BY COUNSEL. THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2009. AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. THE CLAIMANT WAS REVISED ON (B)(6) 2021. ALLEGEDLY, DUE TO HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 20896292 ↗
• InjuryJul 3, 2024Fracture; Fracture

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2008, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2024, DUE TO ALLEGED TRANSVERSE FRACTURE OF THE FEMORAL PROSTHETIC NECK.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19669507 ↗
• InjuryJun 13, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  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 19526547 ↗
• InjuryMay 21, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2011, AND WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD AND AN ACCOLADE TMZF HIP STEM AND WAS REVISED ON (B)(6) 2024. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 19360194 ↗
• InjuryMar 19, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  PATIENT PRESENTED WITH RIGHT HIP PAIN ON (B)(6) 2023 AND HAD X-RAY. REFERRED TO ORTHOPEDICS. ATTENDED ORTHOPEDIC OUTPATIENTS THE NEXT DAY (WAS ABLE TO WALK IN) X-RAY SHOWED HEAD APPEARED TO HAVE DISASSOCIATED FROM TRUNNION. PAST HISTORY OF A FALL APPROXIMATELY 12 MONTHS AGO. REVISION RIGHT TOTAL HIP REPLACEMENT DONE TODAY (B)(6) 2024. ACCOLADE TMZF STEM, V40 LFIT 36MM HEAD AND TRIDENT INSERT REMOVED. NEW TRIDENT X3 INSERT IMPLANTED WITH COMPETITOR DISTAL FITTING STEM.

  Patient problems: Ambulation or Postural Difficulties; Fall

  MAUDE report 18934899 ↗
• InjuryAug 30, 2023Fracture; Fracture

  IT WAS REPORTED BY PATIENT'S ATTORNEY THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN ACCOLADE TMZF AND LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2009, AND WAS REVISED ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT DURING THE REVISION SURGERY IT WAS NOTED THAT THE NECK OF THE PROSTHESIS HAD BROKEN AND THE FEMORAL HEAD WITH THE PIECE OF THE NECK INSIDE WERE SITTING IN THE SOCKET.

  Patient problems: Insufficient Information

  MAUDE report 17653494 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER MEDICAL REVIEW RECEIVED FOR RELATED PI : "THE OPERATION PERFORMED WAS EXCISION OF GREATER TROCHANTERIC BURSA, REPAIR OF CHRONIC ABDUCTOR TEAR AND ARTHROTOMY LEFT HIP" DUE TO PREOPERATIVE DIAGNOSIS OF "CHRONIC ABDUCTOR TEAR LEFT HIP WITH PREVIOUS HIP ARTHROPLASTY WITH CHRONIC GREATER TROCHANTERIC BURSITIS."

  Patient problems: Ambulation or Postural Difficulties; Bursitis; Muscle/Tendon Damage; Pain

  MAUDE report 16918200 ↗
• InjuryJun 1, 2022Corroded; Insufficient Device Problem Information; Corroded; 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) 2006 AND WAS REVISED ON (B)(6) 2021. 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: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 14564998 ↗
• InjuryMay 23, 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 HIS RIGHT HIP ON OR ABOUT (B)(6) 2009 AND WAS REVISED ON (B)(6) 2021. 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: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 14470888 ↗
• InjuryFeb 14, 2022Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component

  AS REPORTED: "THE DOCTOR SAYS FEMORAL HEAD FELL OFF STEM. THE STEM TAPER WAS DAMAGED AND THE NECK OF THE STEM IS NOTCHED." REVISION OF LEFT HIP, SIZE 5 ACCOLADE TMZF STEM AND 40 + 8MM COCR HEAD.

  Patient problems: Insufficient Information

  MAUDE report 13521916 ↗
• InjuryJul 20, 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 ON OR ABOUT (B)(6) 2010 THE PATIENT WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND AN ACCOLADE TMZF V40 TAPER STEM. IT IS FURTHER ALLEGED THAT THE FEMORAL HEAD WHICH HAD BEEN RECALLED IN 2016 COMPLETELY DISLODGED FROM THE TRUNNION AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019.

  Patient problems: Bone Fracture(s); Insufficient Information; Osteolysis; Pain

  MAUDE report 12196219 ↗
• 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 12157255 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO ELEVATED CHROMIUM LEVELS (REPORTED TO THE REP AS "80"). AN ACCOLADE STEM, V40 COCR L-FIT HEAD, AND LINER WERE REVISED WITH NO ALLEGATIONS AGAINST THE LINER. REP REPORTED THAT PICTURES ARE AVAILABLE, BUT OTHERWISE NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12127251 ↗
• InjuryMay 19, 2021Fracture; Fracture

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE TRUNNION BREAKING OFF A BIT BEYOND THE END OF THE FEMORAL HEAD (SIDE CLOSEST TO STEM). INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: TRUNNION WEAR, METALLOSIS, PSEUDOTUMOR, LINER DISCOLORATION. THE STEM, HEAD AND LINER WERE REVISED TO A COMPETITOR STEM AND HEAD WITH AN ELEVATED RIM LINER. REP PROVIDED THE REVISION USAGE SHEET 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 11848067 ↗
• InjuryFeb 11, 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 HER RIGHT HIP ON OR ABOUT (B)(6) 2007 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.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 11318996 ↗
• InjuryFeb 4, 2021Material Erosion; Fracture; Material Erosion; Fracture

  REVISION OF ACCOLADE I STEM.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 11278321 ↗
• InjuryDec 11, 2020Fracture; Fracture

  AS REPORTED: "REVISION OF LEFT HIP DUE TO FRACTURED FEMORAL STEM AT HEAD NECK JUNCTION OF TRUNNION. NO TRAUMA/COMPLICATIONS DURING SURGERY FOR PATIENT." REP PROVIDED AN X-RAY, EXPLANT PICTURES, AND INTRA-OP PHOTOS OF BLACK TISSUE BOTH INSIDE AND REMOVED FROM PATIENT. THE STEM, HEAD, AND POLY INSERT WERE REVISED.

  Patient problems: Foreign Body Reaction; No Information

  MAUDE report 10992510 ↗
• InjuryDec 9, 2020Patient Device Interaction Problem; Patient Device Interaction 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) 2005 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: Foreign Body Reaction

  MAUDE report 10977646 ↗
• InjurySep 18, 2020Migration; Migration

  REVISION RIGHT THA. FEMORAL STEM SUBSIDENCE.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 10556439 ↗
• InjuryFeb 25, 2020Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "CLICKING/ UNSTABLE." REP PROVIDED THE PRIMARY OPERATIVE REPORT AND IMPLANT REPORT, AND PICTURES OF THE EXPLANTS SHOWING DAMAGE TO THE REVISED STEM, HEAD, AND LINER. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9750364 ↗
• InjuryFeb 14, 2020Material Erosion; Device Dislodged or Dislocated; Material Erosion; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISASSOCIATION OF THE FEMORAL HEAD FROM THE STEM. UPON OPENING THE HIP CAPSULE, SURGEON REPORTED THE EXISTENCE OF METALLOSIS. THERE WAS EXCESSIVE GRAY FLUID IN THE CAPSULE, AND SIGNIFICANT WEAR OF THE TRUNNION WAS OBSERVED. THE STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A CERAMIC HEAD AND MDM/ ADM LINER CONSTRUCT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, AND PROVIDED EXPLANT PICTURES AND PRE-REVISION X-RAYS.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Joint Dislocation; Reaction

  MAUDE report 9711256 ↗
• InjuryFeb 10, 2020Degraded; 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) 2005 AND THE FEMORAL HEAD WAS EXPLANTED ON (B)(6) 2013. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

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

  MAUDE report 9689211 ↗