Accolade 6020-0335Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04546540510556), received between Jan 23, 2017 and Sep 16, 2026 — classified as 35 injuries.

The most frequently reported specific device problem is “Degraded” (8 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 35 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Detachment of Device or Device Component

  Patient problems: Joint Dislocation

  MAUDE report 50794455 ↗
• InjurySep 2, 2026Fracture

  Patient problems: Insufficient Information

  MAUDE report 50572826 ↗
• InjuryNov 18, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Metal Related Pathology

  MAUDE report 23587116 ↗
• InjuryNov 25, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  CUSTOMER REPORTED: IT WAS NECESSARY TO REMOVE THE HIP PROSTHESIS DUE TO THE WEAR OF THE TAPER OF THE STEM (6020-0335) IN THE IMPLANT WITH A 40 DIAMETER HEAD (6260-9-140) WHICH DISLOCATED IN THE NECK, IT WAS ALSO NECESSARY TO REMOVE THE INSERT (623-00-40G).

  Patient problems: Insufficient Information

  MAUDE report 20771763 ↗
• InjuryNov 11, 2024Material Erosion; Material Erosion

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2013 AND WAS IMPLANTED WITH A LFIT COCR FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HE WAS REVISED ON (B)(6) 2024 WITH A POSTOPERATIVE DIAGNOSIS OF "SEVERE TENDINOSIS/METALLOSIS WITH A SEVERELY DAMAGED TRUNNION OF THE FEMORAL STEM AS WELL AS SIGNIFICANT DAMAGE TO THE POLYETHYLENE LINER IN THE ACETABULUM".

  Patient problems: Insufficient Information

  MAUDE report 20651133 ↗
• InjuryNov 4, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  ACCOLADE TMZF WITH 36 METAL HEAD. FEMORAL STEM TRUNNION WORN DOWN. HOSPITAL TOOK IMPLANTS AND WAS DOING TESTING.

  Patient problems: Insufficient Information; Pain

  MAUDE report 20598126 ↗
• InjuryAug 31, 2024Material Erosion; Material Erosion

  HIP STEM AND HEAD REVISED DUE TO IMPLANT FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 20114673 ↗
• InjuryMay 3, 2024Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, THE FOLLOWING WAS ALSO NOTED: TRUNNIONOSIS ('BIRD BEAK'), BLACK TISSUE, PSEUDOTUMOR. THE STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, ADM/ MDM POLY INSERT, AND MDM METAL LINER. THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER. REP CAN PROVIDE ADDITIONAL PICTURES, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction

  MAUDE report 19237263 ↗
• InjuryMar 19, 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) 2010 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE UNDERWENT REQUIRED REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 18928188 ↗
• InjuryOct 31, 2023Degraded; Degraded

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT A RTHA ON (B)(6) 2010 WHERE AN ACCOLADE TMZF HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD WERE IMPLANTED. ALLEGEDLY SHE WAS REVISED ON (B)(6) 2020 DUE TO ELEVATED COBALT LEVELS, ALTR AND FLUID COLLECTION.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 18038038 ↗
• InjuryMay 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16859103 ↗
• InjuryDec 21, 2022Corroded; Material Erosion; Detachment of Device or Device Component; Corroded; Material Erosion; Detachment of Device or Device Component

  IT WAS REPORTED TO THE DISTRIBUTOR THAT DURING THE REVISION SURGERY OF ACCOLADE I ITS SHOWS SEVERE TAPER CORROSION. AS REPORTED: "SEVERE ACCOLADE TRUNNION CORROSION LED THE PATIENTS REVISION SURGERY AND BEFORE THE SURGERY THE MENTIONED CORROSION HAS CAUSED SEVERE PAIN, LOSS OF POWER AND INABILITY TO WALK.

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

  MAUDE report 16025667 ↗
• InjuryNov 11, 2022Malposition of Device; Unintended Movement; Malposition of Device; Unintended Movement

  AS REPORTED: "PT. PRESENTED WITH COMPLAINTS OF DISCOMFORT AND FEELINGS OF INSTABILITY IN THE HIP. DR DETERMINED THE HIP STEM SUBSIDED INTO A VALGUS POSITION LEADING TO INSTABILITY. THE SUBSEQUENT MISALIGNMENT LEAD TO DISTAL FIXATION OF THE STEM AGAINST THE MEDIAL CORTEX WHICH SEEMED TO RESULT IN THIGH PAIN. DR. OPTED TO REMOVE THE STEM AND REVISE IT TO A RESTORATION MODULAR CONSTRUCT, CHANGING THE FEMORAL HEAD COMPONENT AS WELL. ALL ACETABULAR COMPONENTS WERE LEFT IN-SITU. NO COMPLAINTS FILED AGAINST THE IMPLANTS THEMSELVES. NO FURTHER INFORMATION AVAILABLE."

  Patient problems: Pain

  MAUDE report 15785297 ↗
• InjuryFeb 10, 2022Corroded; 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 HIS LEFT 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(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE BASED ON MEDICAL REVIEW DATED 26 MARCH 2022: "THERE WAS GRAY AND TAN COLORED SYNOVIUM THROUGHOUT THE LEFT HIP CONSISTENT WITH A PSEUDOTUMOR." SURGEON STATED THAT THE FEMORAL HEAD WAS CHALLENGING TO REMOVE. HE FOUND ¿SUBSTANTIAL AMOUNT OF CORROSION OVER THE TRUNNION AS WELL AS INSIDE OF THE MORSE TAPER OF THE FEMORAL HEAD. THIS WAS CONSISTENT WITH TRUNNIONOSIS.

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

  MAUDE report 13505741 ↗
• InjuryDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TRUNNION-HEAD OF THE ACCOLADE TMZF STEM FAILED AND REQUIRED REVISION.

  Patient problems: Insufficient Information

  MAUDE report 12959878 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALL DEVICE WERE REMOVED DUE TO ARMD. PLEASE INVESTIGATE TRUNNION. AFTER SCREW WAS REMOVED, TRIDENT SHELL COULD BE REMOVED MANUALLY. PLEASE INVESTIGATE IF IN-GROWTH AND ON-GROWTH WAS ADVANCED AND IF THERE WAS ANY DEVICE ISSUE.

  Patient problems: Foreign Body Reaction

  MAUDE report 11640772 ↗
• InjuryJan 27, 2021Corroded; Degraded; Corroded; Degraded

  THE CUSTOMER REPORTED THAT A PATIENT WHO HAD BEEN IMPLANTED WITH AN ACCOLADE TMZF STEM IN 2009 WAS REVISED AS THE TRUNION HAS WORN. THE PATIENT¿S HIP ¿GAVE WAY¿ IN THE SHOWER AND THEY¿VE HAD PAIN FOR 6 MONTHS.

  Patient problems: Pain

  MAUDE report 11237272 ↗
• InjuryDec 16, 2020Adverse 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 HIS LEFT HIP ON OR ABOUT (B)(6) 2009 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: Inflammation; Reaction to Medicinal Component of Device

  MAUDE report 11018820 ↗
• InjuryDec 15, 2020Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE ORTHOPAEDIC ONCOLOGIST WITH A PSEUDO-TUMOR AROUND THE HEAD/TRUNNION JUNCTION OF HER STEM. PATIENT UNDERWENT A REVISION HIP PROCEDURE. THE PSEUDO-TUMOR WAS REMOVED AND A NEW FEMORAL HEAD AND ACETABULAR LINER WERE PUT IN. UPDATE 03DEC2020 - AS PER SALES REP EMAIL, "THE STEM WAS NOT REVISED, AND THE CUP AND LINER WERE STRYKER. THE LINER WAS REPLACED ONLY BECAUSE HE WAS THERE AND HE FELT LIKE IT WAS NECESSARY BECAUSE OF THE METALOSIS IT WAS EXPOSED TO."

  Patient problems: Inflammation; No Information

  MAUDE report 11011695 ↗
• InjurySep 4, 2020Material Erosion; Device Dislodged or Dislocated; Material Erosion; Device Dislodged or Dislocated

  PATIENT CAME TO CLEVELAND CLINIC COMPLAINING OF PROGRESSIVE HIP PAIN. AN X-RAY REVEALED A DISASSOCIATED FEMORAL HEAD DUE TO EXCESSIVE TRUNION WEAR OF THE FEMORAL STEM. DURING SURGERY WAS NOTED THE TRUNION HAD WORN TO THE POINT THAT THE FEMORAL HEAD HAD CAME OFF. AFTER EXPLANTING THE ACCOLADE TMZF STEM A RESTORATION MODULAR STEM WAS USED AS THE REPLACEMENT DEVICE. *UPDATE ON 04-AUG-2021 PER MEDICAL REVIEW: ¿POST-OPERATIVELY IT WAS STATED THAT THERE WAS CATASTROPHIC FAILURE OF THE HIP, TRUNNION FAILURE AT THE TAPER, METAL DISEASE, FEMORAL OSTEOLYSIS WITH A WELL FIXED STEM, WEAR THROUGH AND DESTRUCTION OF THE ACETABULUM, PERIACETABULAR OSTEOLYSIS AND ABDUCTOR DESTRUCTION.¿

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Metal Related Pathology; Pain

  MAUDE report 10497314 ↗
• InjuryAug 13, 2020Corroded; Degraded; Insufficient Device Problem Information; Corroded; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO METALLOSIS AND ELEVATED METAL IONS. AN LFIT V40 HEAD AND POLY LINER WERE REVISED TO A CERAMIC ON POLY BEARING. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Hip Fracture; Inflammation; Injury; Metal Related Pathology; Osteolysis; Reaction

  MAUDE report 10400522 ↗
• InjuryApr 14, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE TRUNNION SHEARING OFF OF THE STEM THE STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, AND MDM LINER WITH ADM/MDM INSERT. THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP PROVIDED THE PRIMARY USAGE SHEET AND A PRE-REVISION X-RAY AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Injury

  MAUDE report 9957177 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT RELATIONS COORDINATOR CALLED INQUIRING ABOUT A RECALL FOR PATIENT'S HIP IMPLANTS. SHE STATED THE PATIENT CLAIMS TO PRESENT SIGNS OF METALLOSIS.

  Patient problems: Inflammation; Reaction

  MAUDE report 9258109 ↗
• InjurySep 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNIONOSIS. INTRA-OPERATIVELY, BLACK MATERIAL WAS NOTED INSIDE THE FEMORAL HEAD. A 36 -5 LFIT V40 HEAD AND POLY LINER WERE REVISED TO A BIOLOX HEAD WITH SLEEVE AND POLY LINER. THE STEM WAS NOT REVISED AND REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE LINER. REP HAS SOME PICTURES TO PROVIDE AND CAN RETURN THE EXPLANTS, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8984139 ↗
• InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  TOTAL HIP REPLACEMENT RIGHT ON (B)(6) 2013. REVISION SURGERY: IMPLANTATION STEM ON(B)(6) 2019.

  Patient problems: Injury

  MAUDE report 8728983 ↗