Accolade 6021-3535Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 04546540510754), received between Jun 18, 2018 and Sep 2, 2026 — classified as 68 injuries.

The most frequently reported specific device problem is “Degraded” (26 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 68 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50573015 ↗
• InjuryNov 12, 2025Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: A PATIENT WHO UNDERWENT THA (ACCOLADE TMZF) ON (B)(6) 2012. THE NECK TRUNNION OF THE ACCOLADE TMZF WORE OUT, CAUSING THE HEAD TO DISLOCATE FROM THE STEM WITHIN THE HIP JOINT, NECESSITATING REVISION ARTHROPLASTY ON (B)(6) 2025. DURING THE REVISION SURGERY, THE SURGEON OBSERVED METALLOSIS OF THE SURROUNDING TISSUES ASSOCIATED WITH STEM WEAR.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 23533806 ↗
• InjuryJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  CLAIMANT, THROUGH COUNSEL, ALLEGES THAT HE UNDERWENT A RIGHT THA ON (B)(6) 2010, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND AN ACCOLADE TMZF STEM. HE SUBSEQUENTLY WAS REVISED ON (B)(6) 2024, DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22310622 ↗
• InjuryMay 19, 2025Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PAIN AND VISUAL (IMPLANT) DEFORMITY. CLICKING. ALL AVAILABLE INFORMATION SUBMITTED.' STEM WITH A VERY WORN TRUNNION.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 22042708 ↗
• InjuryMar 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 21540731 ↗
• InjuryMar 6, 2025Degraded; Degraded

  PATIENT AT HOSPITAL WITH HIP PROBLEMS. INVESTIGATION SHOWS THAT ACCOLADE TAPER ARE ERODED AND HEAD ELONGATED. SURGEON PLAN TO PERFORM A STEM/HEAD/INSERT REVISION AT A LATER DATE.

  Patient problems: Insufficient Information

  MAUDE report 21535309 ↗
• InjuryFeb 11, 2025Degraded; Fracture; Detachment of Device or Device Component; Degraded; Fracture; Detachment of Device or Device Component

  PATIENT WAS REVISED BECAUSE THE TRUNNION FRACTURED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 21357870 ↗
• InjurySep 23, 2024Material Erosion; Material Erosion

  THE STEM WAS IMPLANTED INTO THE PATIENT'S FEMUR ON (B)(6) 2011. WHEN THE PATIENT STOOD UP TO USE THE TOILET AT HOME, HE HEARD A POPPING SOUND AND THEN BEGAN TO FEEL UNCOMFORTABLE. THUS, HE VISITED THE HOSPITAL AND X-RAY EXAMINATION WAS PERFORMED. THE DOCTOR DETERMINED THAT THE STEM MAY HAVE BROKEN, AND THE DECISION WAS MADE TO PERFORM REVISION SURGERY. ON (B)(6)2024, THE REVISION SURGERY WAS PERFORMED AND IT WAS CONFIRMED THAT THE STEM WAS NOT BROKEN, BUT DISLOCATION OF THE HEAD DUE TO WEAR OF THE STEM WAS FOUND. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY AND THE STEM WAS DISCARDED AFTER THE SURGERY.

  Patient problems: Discomfort

  MAUDE report 20277165 ↗
• InjurySep 10, 2024Degraded; 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

  REVISION SURGERY. SALES REP REPORT: "I NEED TO REGISTER A NEW PER PLEASE. BASIC INFORMATION BELOW, BUT IF YOU CAN SEND ME THE LIST OF NORMAL QUESTIONS/FORM, I CAN SEND THEM ONTO THE SURGEON, WHO IS HAPPY TO COMPLETE. PATIENT WAS ADMITTED LATE LAST WEEK, AND WAS PLACED ON THE TRAUMA LIST FOR TODAY. SURGEON TO CONFIRM ALL INFORMATION RELATING TO TODAY¿S PROCEDURE. BUT ULTIMATELY, THE ORIGINAL ACCOLADE STEM WAS REMOVED, AND REPLACED WITH AN EXETER CEMENTED STEM (DETAILS TBC), WITH A BIOLOX DELTA CERAMIC HEAD (DETAILS TBC). THE ORIGINAL TRIDENT ACETABULAR SHELL IN THE PATIENT WAS RETAINED, BUT THE 36MM POLY LINER WAS REPLACED (DETAILS TBC). THE IMPLANTS REMOVED FROM THE PATIENT (ACCOLADE STEM, COCR V40 METAL HEAD, TRIDENT POLY LINER) HAVE ALL BEEN RETAINED BY THE HOSPITAL, AND HAVE BEEN SENT FOR A FULL DECONTAMINATION. ONCE RETURNED, THE HOSPITAL ARE HAPPY TO RETURN THE IMPLANTS TO STRYKER FOR INVESTIGATION. THE SURGEON ALSO TOOK PHOTOS OF THE REMOVED ITEMS, AND IS HAPPY TO SHARE.".

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 20182549 ↗
• InjuryJul 26, 2024Degraded; Material Erosion; Degraded; Material Erosion

  HIP REVISION. X-RAY DISPLAYED IRREGULAR ANGLE OF HEAD ON TRUNNION. ONCE JOINT OPENED, STEM TRUNNION NOTICED TO BE WORN ON UNDERSIDE.

  Patient problems: Insufficient Information

  MAUDE report 19839457 ↗
• InjuryJul 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR REVISION OF PATIENT'S LEFT HIP ON (B)(6) 2019. THE PATIENT HAD A REVISION DUE TO HAVING A RECALLED HEAD. THE V40 METAL HEAD AND A POLY LINER WERE REVISED. IT WAS NOTED, "LINER HAD MODEST WEAR PRESENT BUT NO OSTEOLYSIS" ... "THERE WAS BLACK STAINING PRESENT ABOUT THE TRUNNION BUT NO DEFORMATION OF THE TRUNNION." REP REPORTED THAT THE HOSPITAL AND SURGEON WILL NOT RELEASE ANY ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19669300 ↗
• InjuryJun 7, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT HAD A HIP REVISION DUE TO DISASSOCIATION. IT WAS ALSO NOTICED THE TRUNNION WAS WORN.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19483923 ↗
• InjuryMar 20, 2024Fracture; Fracture

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE UNDERWENT REVISION SURGERY ON (B)(6) 2023, DUE TO ALLEGED FRACTURE THROUGH THE FEMORAL NECK OF THE STEM.

  Patient problems: Insufficient Information

  MAUDE report 18940307 ↗
• InjuryNov 7, 2023Break; Material Erosion; Detachment of Device or Device Component; Break; Material Erosion; Detachment of Device or Device Component

  REVISION SURGERY DUE TO STEM BREAKAGE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 18083235 ↗
• InjuryOct 4, 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 LEFT HIP ON OR ABOUT (B)(6) 2013, AND WAS REVISED ON (B)(6) 2022. IT IS FURTHER ALLEGED THAT THE PATIENT 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: Metal Related Pathology

  MAUDE report 17873715 ↗
• InjurySep 5, 2023Fracture; Fracture

  IT WAS REPORTED BY PATIENT'S ATTORNEY THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN ACCOLADE TMZF HIP STEM AND LFIT ANATOMIC V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2007, AND WAS REVISED ON (B)(6) 2022 DUE TO FEMORAL NECK FRACTURE.

  Patient problems: Insufficient Information

  MAUDE report 17687540 ↗
• InjurySep 5, 2023Material Erosion; Material Erosion

  IT WAS REPORTED BY PATIENT'S ATTORNEY THAT ALLEGEDLY THE PATIENT UNDERWENT BILATERAL HIP ARTHROPLASTY ON (B)(6) 2010, AND WAS IMPLANTED WITH ACCOLADE TMZF HIP STEMS AND LFIT V40 FEMORAL HEADS. IT IS FURTHER ALLEGED THE LEFT HIP WAS REVISED ON (B)(6) 2021, DUE TO SEVERE TRUNNIONOSIS WITH DISLOCATION OF THE FEMORAL HEAD. DURING THE REVISION SURGERY THE TRUNNION WAS NOTED TO BE GROSSLY DEFORMED AND TAPERED TO A SHARP POINT.

  Patient problems: Insufficient Information

  MAUDE report 17687309 ↗
• InjurySep 5, 2023Material Erosion; Material Erosion

  IT WAS REPORTED BY PATIENT'S ATTORNEY THAT ALLEGEDLY THE PATIENT UNDERWENT BILATERAL HIP ARTHROPLASTY ON (B)(6) 2010, AND WAS IMPLANTED WITH ACCOLADE TMZF HIP STEMS AND LFIT V40 FEMORAL HEADS. IT IS FURTHER ALLEGED THE RIGHT HIP WAS REVISED ON (B)(6) 2021 AND DURING REVISION IT WAS NOTED THAT THE TRUNNION HAD BEEN FILED DOWN TO A POINT LIKE STRUCTURE BASED ON THE MOVEMENT OF THE HEAD AROUND THE PROXIMAL FEMUR.

  Patient problems: Insufficient Information

  MAUDE report 17687099 ↗
• InjurySep 1, 2023Material Erosion; Material Erosion

  IT WAS REPORTED BY PATIENT'S ATTORNEY THAT ALLEGEDLY PLAINTIFF WAS IMPLANTED WITH AN ACCOLADE TMZF HIP STEM AND LFIT COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON (B)(6) 2016, AND WAS REVISED ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT X-RAY SHOWED THE FEMORAL NECK PORTION OF THE STEM DEFORMED AND ANGULATED.

  Patient problems: Insufficient Information

  MAUDE report 17668797 ↗
• InjuryJun 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT HAS BEEN REPORTED "REVISED STEM DUE TO TRUNNION DAMAGE, HEAD DISASSOCIATION."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 17069111 ↗
• InjuryMay 16, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HIP REVISION WAS PERFORMED FOR FAILURE OF AN ACCOLADE STEM TRUNNION. UPDATE: HEAD DISASSOCIATION HAS BEEN NOTED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 16937922 ↗
• 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 16910683 ↗
• InjuryFeb 7, 2023Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; 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 HIS RIGHT HIP ON OR ABOUT (B)(6) 2013 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. UPDATE 13-APRIL-2023: PER REVISION OPERATIVE REPORT, THE FEMORAL HEAD HAD DISASSOCIATED FROM THE STEM DUE TO "BIRD BEAK" TYPE WEAR OF THE STEM TRUNNION. THICK BLACK LIQUID CONSISTENT WITH METALLOSIS WAS OBSERVED. THE STEM, HEAD AND LINER WERE REVISED. THERE WERE NO REPORTED ALLEGATIONS AGAINST THE LINER STATED IN THE OP REPORT. THE CUP WAS FOUND TO BE WELL-FIXED SO IT WAS NOT REVISED.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 16315831 ↗
• InjurySep 16, 2022Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY, REPORTED TO HAVE BEEN CAUSED BY THE STEM BEING LOOSE/ NOT INGROWN. AN ACCOLADE STEM, HEAD AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, ANOTHER HEAD, AND LINER. A SCREW WAS ALSO REMOVED, BUT NO REASON WAS REPORTED TO THE REP AS TO WHY. REP CONFIRMED HEAD AND LINER DID NOT CONTRIBUTE TO INSTABILITY AND HAD NO OTHER ALLEGATIONS AGAINST THEM.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 15437014 ↗
• InjuryMay 25, 2022Degraded; 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 THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2022. 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

  MAUDE report 14493771 ↗