Accolade 6021-2530Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 04546540510747), received between Jul 3, 2018 and Sep 27, 2024 — classified as 37 injuries.

The most frequently reported specific device problem is “Degraded” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2024Degraded; Degraded

  THA WAS PERFORMED ON (B)(6) 2010 AND THE STEM WAS IMPLANTED IN THE PATIENT'S LEFT HIP. THE REVISION SURGERY TO REPLACE THE STEM WAS PERFORMED ON (B)(6) 2024 DUE TO STEM NECK WEAR (TRUNNIONOSIS).

  Patient problems: Insufficient Information

  MAUDE report 20319904 ↗
• InjuryAug 21, 2024Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  AS REPORTED: "PATIENT IS STATUS POST REVISION LTHA DUE TO TRUNNIONOSIS AND DISSOCIATION (THE STEM DISLOCATED FROM THE HEAD. THE HEAD STAYED IN THE CUP). NO ADDITIONAL DETAILS WERE PROVIDED." A STEM, HEAD, AND LINER WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20009801 ↗
• InjuryMar 6, 2024Degraded; Material Erosion; Degraded; Material Erosion

  AS PER THE MEDICAL REVIEW: "THE PATIENT PRESENTED TO HER SURGEON IN (B)(6)2022 WITH LEFT GROIN AND HIP PAIN ALONG WITH BACK PAIN. A BONE SCAN WAS ORDERED ALONG WITH LABS. THESE WERE REVIEWED WITH PATIENT IN (B)(6)2022. ELEVATED COBALT LEVELS IN A PATIENT WITH BILATERAL PRESS FIT THAS IS CONFIRMED."

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18844247 ↗
• InjuryNov 10, 2023Degraded; Material Erosion; Degraded; Material Erosion

  STUDY SUBJECT: UNDER INVESTIGATION FOR CONTRALATERAL KNEE AND UPPER LEG PAIN AFTER FALL, ELEVATED COBALT BLOOD LEVELS FOUND.

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

  MAUDE report 18109324 ↗
• InjuryOct 23, 2023Degraded; Degraded

  THE FOLLOWING WAS REPORTED: SUBJECT WAS UNDER INVESTIGATION FOR BACK PAIN (NOT RELATED TO HIP IMPLANT): BLOOD SAMPLE SHOWED ELEVATED COBALT AND RIGHT HIP PROSTHESIS SHOWS WEARING (SUBJECT HAS NO SYMPTOMS).

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

  MAUDE report 17988930 ↗
• InjuryAug 25, 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 PAIN, INSTABILITY, AND TRUNNIONOSIS. SURGEON REPORTED VIA PRE-REVISION X-RAY THAT THE CUP HAD TOO MUCH ANTEVERSION. INTRA-OPERATIVELY, THE HEAD WAS FOUND TO BE 'A LITTLE LOOSE' ON THE TRUNNION. THE PATIENT'S ENTIRE HIP CONSTRUCT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A NEW HEAD, LINER AND SHELL. WHILE REAMING FOR THE NEW SHELL, THE PATIENT'S FEMORAL ARTERY WAS SEVERED. A VASCULAR SURGEON WAS BROUGHT IN TO ADDRESS THE ISSUE AND PERFORM A BYPASS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 3 HOURS. THE PATIENT WAS EVENTUALLY PRONOUNCED STABLE AFTER HAVING GONE TO THE ICU. REP CONFIRMED THAT NO STRYKER IMPLANTS OR INSTRUMENTS CONTRIBUTED TO THE SEVERING OF THE ARTERY, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 17622361 ↗
• InjuryAug 24, 2023Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  THE NECK OF THE ACCOLADE TMZF WAS DAMAGED DUE TO WEAR, WHICH CAUSED THE METAL HEAD TO COME OFF. METALOSIS WAS ALSO CONFIRMED DURING REVISION SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Metal Related Pathology

  MAUDE report 17609801 ↗
• 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) 2008, THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND AN ACCOLADE HIP STEM. IT IS FURTHER ALLEGED THAT X-RAYS DEMONSTRATED DISASSOCIATION OF THE FEMORAL HEAD AND SIGNIFICANT WEAR WAS NOTED ON THE TRUNNION. THE PATIENT WAS REVISED ON (B)(6) 2021.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16959802 ↗
• InjuryJul 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT HAD TOTAL HIP 13 YEARS AGO AND RECENTLY STARTED TO EXPERIENCE PAIN IN HER HIP. UPDATE AS PER MED REVIEW COMMENT: "THE X-RAY SHOWS DISSOCIATION OF THE FEMORAL HEAD WITH DEFORMATION OF THE TRUNNION. THE CUP HAS LOST FIXATION AND IS NOW ORIENTED VERTICALLY. "

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 15037564 ↗
• InjuryMay 13, 2022Degraded; 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) 2010 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 AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Metal Related Pathology

  MAUDE report 14391894 ↗
• InjuryFeb 14, 2022Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  PATIENT HAD SEVERE METALLOSIS, TRUNNIONOSIS. SURGEON NOTED THAT THE TRUNNION WAS SEVERELY WORN DOWN AND THE HEAD FELL OFF THE STEM. RIGHT SIDE.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 13521920 ↗
• InjuryFeb 4, 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 HER LEFT HIP ON OR ABOUT (B)(6) 2009 AND WAS REVISED ON (B)(6) 2020. 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: Discomfort; Metal Related Pathology

  MAUDE report 13459189 ↗
• InjuryJan 31, 2022Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED BY REP: "THE PATIENT CAME TO DR ON (B)(6) 2021, AFTER SEEING A CHIROPRACTOR, COMPLAINING OF HIP PAIN. AN X-RAY REVEALED A SEVERELY WORN TRUNNION. DURING SURGERY IT WAS NOTED THE TRUNION HAD SEVERE WEAR. A RESTORATION MODULAR STEM WAS USED AS THE REPLACEMENT DEVICE." REP PROVIDED AN X-RAY SHOWING THE HEAD DISSOCIATED FROM THE STEM.

  Patient problems: Pain

  MAUDE report 13392400 ↗
• InjuryJan 21, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  RIGHT SIDE HIP REVISION, ALL COMPONENTS EXPLANTED WERE STRYKER COMPONENTS. THE PATIENT WAS RE-IMPLANTED WITH NEW REVISION STRYKER COMPONENTS. THE PATIENT RECENTLY WAS REPORTING PAIN IN HER RIGHT HIP, X-RAYS SHOWED A DISASSOCIATION AND INTRAPROSTHETIC DISLOCATION OF THE FEMORAL HEAD FROM THE TRUNNION OF THE STEM. THE PATIENT¿S COBALT CHROME LEVELS WERE ELEVATED AND THE STEM/FEMORAL HEAD JUNCTION WAS FAILED, SO THE SURGEON NEEDED TO REVISE THE FEMORAL COMPONENT. THERE WERE ADVERSE LOCAL TISSUE REACTIONS SURROUNDING THE COMPONENT, THE FEMORAL HEAD HAD CORROSION AND SEVERE WEAR WAS NOTED ON THE TRUNNION AS THE FEMORAL HEAD WAS FRACTURED OFF.

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

  MAUDE report 13314420 ↗
• InjuryJan 21, 2022Degraded; 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) 2012 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(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

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

  MAUDE report 13313449 ↗
• InjuryOct 29, 2021Corroded; Degraded; Corroded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ELEVATED CHROMIUM AND COBALT LEVELS. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: ADVERSE SOFT TISSUE REACTION, OSTEOLYSIS, BLACK DEBRIS AT THE BASE OF THE FEMORAL HEAD, TRUNNION WEAR, AND THE SURGEON REPORTED THE LINER DID NOT FEEL AS SMOOTH AS IT SHOULD. THE HEAD AND LINER WERE REVISED TO A NEW LINER AND CERAMIC HEAD WITH SLEEVE. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS, AND REPORTED THAT THE HOSPITAL WOULD LIKE INVESTIGATION RESULTS WHEN THE EXPLANTS ARE RECEIVED. REP OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 12720246 ↗
• InjurySep 29, 2021Break; Material Erosion; Detachment of Device or Device Component; Break; Material Erosion; Detachment of Device or Device Component

  AS REPORTED: "AN ACCOLADE TMZF WAS BEING REVISED. REASON FOR THE REVISION IS THE FEMORAL HEAD BROKE OFF THE TRUNNION BECAUSE OF WEAR AND FRETTING AND POSSIBLE IMPINGEMENT. FAILURE OF BIG LFIT METAL HEAD AND TMZF TRUNNION." REP PROVIDED PRIMARY AND REVISION USAGE SHEETS, X-RAY AND EXPLANT PICTURES. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 12549652 ↗
• InjuryJul 22, 2021Degraded; Material Erosion; Fracture; Degraded; Material Erosion; Fracture

  THA WITH A COMBINATION OF ADEPT CUP 50 MM, HEAD 44 MM PLUS 8 MM AND ACCOLADE TMZF. METALLOSIS IS PROMINENT AND THE NECK IS DAMAGED DUE TO CORROSION OF THE NECK. THERE IS NO DOUBT THAT IT IS METALLOSIS.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 12209040 ↗
• InjuryJun 10, 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) 2010 AND WAS REVISED ON (B)(6) 2020. 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 11972850 ↗
• InjuryApr 16, 2021Failure to Osseointegrate; Failure to Osseointegrate

  AS REPORTED: "PATIENT¿S LEFT HIP FEMORAL COMPONENT WAS REVISED DUE TO LOOSENING." SPOKE TO REP, WHO CONFIRMED IT WAS THE ACCOLADE TMZF STEM WAS LOOSE. THE STEM, HEAD, AND LINER WERE REVISED. REP PROVIDED AN IMPLANT REPORT FOR THE PATIENT, CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, AND ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11682350 ↗
• InjuryFeb 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT UNDERWENT THE INITIAL SURGERY ON (B)(6) 2020 AT OTHER HOSPITAL. ON (B)(6) 2020 THE PATIENT UNDERWENT REVISION SURGERY AT THE REPORTING HOSPITAL DUE TO DISLOCATION. THE REPORTING SR EXPLAINED TO THE SURGEON THAT THE PLASTIC NECK WAS POSSIBLY WORE BECAUSE IT WAS A CASE WITH LARGE HEAD OF 36MM OR MORE, THE PATIENT WAS IN HIGH ACTIVITY, AND HIGH OFFSET. UPDATE JANUARY 25, 2021: THERE WAS DISENGAGEMENT OR FRACTURE AT THE NECK/HEAD JUNCTION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11274373 ↗
• InjuryJan 26, 2021Degraded; Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Degraded; Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE NECK OF THE STEM BEING BROKEN AND DISSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, SOME BLACK TISSUE AND LINER DAMAGE WERE NOTED. THE STEM, HEAD AND LINER WERE REVISED. REP CAN PROVIDE PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction; Insufficient Information

  MAUDE report 11233834 ↗
• InjuryNov 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN AND ELEVATED COCR LEVELS. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: GRAY TISSUE, BONE RESORBTION, AND BLACK DEBRIS INSIDE THE HEAD/ TRUNNION INTERFACE. THE SURGEON CLEANED OFF THE TRUNNION OF THE IN-SITU STEM AND REVISED A COCR FEMORAL HEAD AND LINER TO A BIOLOX CERAMIC HEAD WITH SLEEVE, MDM METAL LINER, AND ADM/ MDM POLY INSERT. NO ALLEGATIONS WERE MADE AGAINST THE REVISED LINER.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 10860945 ↗
• InjurySep 28, 2020Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO ELEVATED LEVELS OF CHROMIUM AND COBALT. INTRA-OPERATIVELY, IT WAS OBSERVED THERE WAS NO SOFT TISSUE DAMAGE AND MINOR TRUNNION WEAR. THE POLY LINER AND HEAD WERE REVISED TO A CERAMIC HEAD WITH SLEEVE AND NEW LINER. REP PROVIDED PICTURES OF THE EXPLANTS AND AN X-RAY. REP REPORTED HE MAY BE ABLE TO GET ADDITIONAL PATIENT INFORMATION AND THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, OTHERWISE NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation

  MAUDE report 10592330 ↗
• InjuryJun 26, 2020Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO CORROSION. THE PATIENT'S STEM, HEAD AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP CAN PROVIDE SOME DEVICE PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 10199469 ↗