Accolade 6021-0335Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 04546540510686), received between Nov 6, 2017 and Mar 4, 2026 — classified as 91 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (33 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 93 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2008 AND WAS IMPLANTED WITH LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. THE RIGHT HIP WAS REVISED ON (B)(6) 2024 DUE TO ALLEGED HEAD DISSOCIATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 24505310 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Insufficient Information; Urinary Tract Infection

  MAUDE report 24363027 ↗
• InjuryOct 21, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 23353826 ↗
• InjuryFeb 6, 2025Material Erosion; Material Erosion

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2015, AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE WAS REVISED ON (B)(6) 2022 DUE TO ALLEGED SEVERE TRUNNION WEAR AND CONCERN FOR PSEUDOTUMOR.

  Patient problems: Foreign Body Reaction

  MAUDE report 21321414 ↗
• InjuryJan 27, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  BROKEN HIP PROSTHESIS. THE REVISION OF THE HIP TOOK PLACE TODAY.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21239225 ↗
• InjuryNov 6, 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) 2013 AND WAS IMPLANTED WITH A LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HE WAS REVISED ON (B)(6) 2024, DUE TO ALLEGED FEMORAL HEAD DISSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 20622343 ↗
• InjuryAug 12, 2024Degraded; Degraded

  THE SALES REPRESENTATIVE LEARNED THAT THE CLINIC HAS A LEGAL DISPUTE WITH A PATIENT WHO HAD TO UNDERGO AN ACCOLADE + MITCH REVIEW FOR METALLOSIS.

  Patient problems: Metal Related Pathology

  MAUDE report 19966869 ↗
• InjuryJul 24, 2024Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  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 19823701 ↗
• InjuryJun 7, 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 RIGHT THA ON (B)(6) 2013, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 19488961 ↗
• InjuryFeb 12, 2024Material Erosion; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Erosion; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE REP: REVISION WAS PERFORMED. UPDATE PER MEDICAL RECORDS: THE PATIENT WAS REVISED DUE TO DISASSOCIATION OF THE METAL HEAD FROM THE STEM. SEVERE WEARING OF THE STEM TRUNNION ALSO RESULTED IN METALLOSIS. RIGHT HIP.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18683979 ↗
• InjuryJan 26, 2024Degraded; Degraded

  IT WAS REPORTED BY COUNSEL THAT PATIENT UNDERWENT LEFT THA ON (B)(6) 2012 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. THE PATIENT WAS INFORMED THAT THERE WAS A RECALL ON HER IMPLANTS AND METAL ION TESTING SHOWED ELEVATION. HER LEFT HIP WAS REVISED ON (B)(6) 2022.

  Patient problems: Metal Related Pathology

  MAUDE report 18585826 ↗
• InjuryJan 25, 2024Degraded; Degraded

  IT WAS REPORTED BY COUNSEL THAT PATIENT UNDERWENT RIGHT THA ON (B)(6) 2012, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. THE PATIENT WAS INFORMED THAT THERE WAS A RECALL ON HER IMPLANTS AND METAL ION TESTING SHOWED ELEVATION. HER RIGHT HIP WAS REVISED ON (B)(6) 2022.

  Patient problems: Metal Related Pathology

  MAUDE report 18585013 ↗
• InjuryOct 30, 2023Degraded; Degraded

  ON (B)(6) 2012, THA WAS PERFORMED AND THE ACCOLADE TMZF WAS IMPLANTED. ON (B)(6) 2023, TRUNNIONOSIS WAS CONFIRMED AND THE DOCTOR DECIDED TO PERFORM REVISION SURGERY ON (B)(6) 2023 TO REMOVE THE ACCOLADE TMZF.

  Patient problems: Insufficient Information

  MAUDE report 18035819 ↗
• InjuryAug 31, 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 RIGHT HIP ON OR ABOUT (B)(6) 2009, AND WAS REVISED ON (B)(6) 2021. HE PRESENTED TO THE ER WHERE THE STEM NECK FRACTURE WAS IDENTIFIED ON RADIOGRAPHS. IT IS FURTHER ALLEGED THAT DURING THE REVISION THE SMALL PROXIMAL FRACTURED PART OF THE STEM WAS STILL LOCATED WITHIN THE METAL FEMORAL HEAD AND THESE WERE REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 17660380 ↗
• InjuryAug 2, 2023Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. INTRA-OPERATIVELY, THE TRUNNION WAS FOUND TO BE WORN/ DEFORMED. THE STEM, HEAD, AND LINER WERE REVISED.

  Patient problems: Pain

  MAUDE report 17446682 ↗
• InjuryJul 13, 2023Degraded; Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated; Degraded; Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISSOCIATION OF THE FEMORAL HEAD FROM THE STEM CAUSED BY THE WEARING DOWN OF THE TRUNNION. THE STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, MDM/ ADM POLY INSERT AND MDM METAL LINER. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 17313850 ↗
• InjuryJun 1, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN AND ASEPTIC LOOSENING OF THE FEMORAL STEM. THE STEM, CERAMIC HEAD, AND COMPETITOR LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A METAL HEAD AND ANOTHER COMPETITOR LINER.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17036570 ↗
• InjuryMay 19, 2023Material Erosion; Material Erosion

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT ALLEGEDLY ON (B)(6), 2011, THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD AND A ACCOLADE TMZF HIP STEM. IT IS FURTHER ALLEGED THE PATIENT WAS REVISED ON (B)(6) 2021, DUE TO ELEVATED COBALT AND CHROMIUM LEVELS AND PAIN IN THE RIGHT HIP.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 16962560 ↗
• InjuryApr 25, 2023Corroded; 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 ON OR ABOUT (B)(6) 2011 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 AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. UPDATE: PER MEDICAL RECORDS RECEIVED, PATIENT ALSO EXHIBITED ALTR. CORROSION WAS OBSERVED AT THE STEM-HEAD INTERFACE INTRAOPERATIVELY. THE TRUNNION WAS WIPED CLEAN AND THE STEM WAS LEFT IMPLANTED AS IT WAS WELL-FIXED. THE SHELL WAS ALSO REVISED AS THE SURGEON FELT THE PATIENT "WOULD BENEFIT FROM REVISION TO A LARGER CUP WHICH IS MORE ANTEVERTED LESS VERTICAL."

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

  MAUDE report 16812425 ↗
• InjuryFeb 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PATIENT 'S ATTORNEY THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND WAS IMPLANTED WITH A 36 MM +5 LFIT ANATOMIC V40 FEMORAL HEAD AND AN ACCOLADE TMZF HIP STEM. THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 16289918 ↗
• InjuryNov 7, 2022Degraded; Degraded

  IT WAS REPORTED THROUGH A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2021. THE REVISION OPERATIVE REPORT NOTED "... DESTRUCTION OF THE TRUNNION, SEVERE METALLOSIS, SIGNIFICANT WEAR OF THE POLYETHYLENE AND METALLOSIS THROUGHOUT THE SYNOVIAL CAPSULE."

  Patient problems: Foreign Body Reaction

  MAUDE report 15742467 ↗
• InjuryOct 5, 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 HER LEFT HIP ON OR ABOUT (B)(6) 2011 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 AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Metal Related Pathology

  MAUDE report 15542059 ↗
• InjurySep 26, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  STEM FRACTURE (ACCOLADE I) 14 YEARS AFTER IMPLANTATION AND REGULAR FUNCTION. A REVISION SURGERY DUE TO THE SHAFT FRACTURE IS NOW PLANNED. A COMPLEX REVISION SURGERY MUST BE PERFORMED HERE. SURGERY DATE SEPTEMBER 6, AFTER SURGERY DEFECT ITEM CAN BE RETURNED. UPDATE: THE PROSTHESIS NECK IS NOT BROKEN. THE HEAD HAS LOOSENED AND BADLY DAMAGED THE CONE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15487415 ↗
• InjurySep 15, 2022Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  AS REPORTED BY REP: "CASE REPORT: PATIENT WHO UNDERWENT SURGERY APPROXIMATELY 12 YEARS AGO FOR A LEFT TOTAL HIP ARTHROPLASTY, PRESENTED WITH PAIN AND X-RAYS SHOWED A FEMORAL HEAD DISASSOCIATION FROM THE TRUNNION OF THE STEM. THE ORIGINAL STRYKER IMPLANTS IMPLANTED WERE: ACCOLADE TMZF SIZE 3X132 STEM, A 32+8 V40 COCR FEMORAL HEAD, A SIZE 50 TRIDENT PSL HA HEMISPHERICAL ACETABULAR SHELL, WITH NO SCREWS, AND SIZE 32 E 10° X3 POLYETHYLENE LINER. THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM, A REVISION HIP WAS PERFORMED ON THE LEFT SIDE, THE HEAD WAS FRACTURED FROM THE TRUNNION ON THE STEM. REP CONFIRMED THE HEAD HAD WORN THE TRUNNION DOWN AND BECAME DISSOCIATED, THE STEM DID NOT FRACTURE, THE HEAD WAS FREE IN THE ACETABULUM CAUSING IMPINGEMENT AND METALLOSIS. THERE WAS ADVERSE LOCAL TISSUE REACTIONS FROM THE TRUNNIONOSIS HOWEVER THE ADDUCTORS WERE INTACT. ANOTHER COMPANY'S REVISION STEM WAS USED, THE TRIDENT CUP WAS RETAINED AND A NEW 36MM SIZE E 10 0° LINER WAS PUT INTO THE CUP."

  Patient problems: Foreign Body Reaction

  MAUDE report 15433478 ↗
• InjuryMay 13, 2022Degraded; 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. THE STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, FEMORAL HEAD, AND LINER. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 14389819 ↗