Accolade 6721-0435Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 04546540669490), received between Jun 12, 2017 and Feb 25, 2026 — classified as 79 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (27 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 82 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Material Erosion

  THE FOLLOWING INFORMATION WAS PROVIDED: METALLOSIS OF PRIOR STRYKER THA FROM 2023 LEADING TO COMPROMISED SOFT TISSUES AND STABILITY. METAL HEAD (CAT 62609136 AND LOT HN6J35) AND LINER WERE REMOVED AND REPLACED WITH A UNIVERSAL SLEEVE WITH A 28 CERAMIC UNIVERSAL HEAD AND A CONSTRAINED LINER. THE ACCOLADE STEM IMPLANTED IN 2023 AND LEFT IN THERE IS CAT 67210435 AND LOT 71540802.

  Patient problems: Foreign Body Reaction

  MAUDE report 24443307 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THIGH PAIN AND START-UP PAIN. THE STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, FEMORAL HEAD, MDM/ ADM POLY INSERT, AND MDM METAL LINER. REP CONFIRMED THAT STEM WAS NOT NOTED TO BE LOOSE, AND THAT THE SURGEON 'HAD TO WORK TO GET IT OUT.' THE REASON FOR CONVERTING THE LINER TO MDM WAS NOT REPORTED TO THE REP, REP REPORTED THAT THE HIP WAS STABLE WITH THE ORIGINAL LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 21321849 ↗
• InjuryJan 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 II HIP STEM. HER RIGHT HIP WAS REVISED ON (B)(6) 2024 ALLEGEDLY DUE TO ELEVATED COBALT AND CHROMIUM AND ADVERSE TISSUE REACTION.

  Patient problems: Metal Related Pathology

  MAUDE report 21080711 ↗
• InjuryNov 6, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNION DEFORMATION AND HEAD DISSOCIATION. THE STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, FEMORAL HEAD, ADM/ MDM POLY INSERT, AND MDM METAL LINER. 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: Joint Dislocation

  MAUDE report 20622307 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A FEMORAL FRACTURE SUSTAINED IN A FALL. A HEMI HIP WAS REMOVED AND ANOTHER HEMI HIP WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 20233312 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PERIPROSTHETIC FRACTURE. STEM AND FEMORAL HEAD REVISED. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Bone Fracture(s)

  MAUDE report 20155375 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A LEFT HIP STEM AND HEAD/SLEEVE ON A PATIENT DUE TO PERI-PROSTHETIC FRACTURE. HE REVISED TO A CORIN STEM/HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 19925166 ↗
• InjuryApr 23, 2024Degraded; Degraded

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2017 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND A ACCOLADE II HIP STEM. SHE WAS REVISED ON (B)(6) 2022 DUE TO ALLEGED METALLOSIS AND TRUNNIONOSIS.

  Patient problems: Foreign Body Reaction

  MAUDE report 19162390 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS STATUS POST REV. LTHA DUE TO FEMORAL TO HIP FRACTURE. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE FACILITY.

  Patient problems: Bone Fracture(s)

  MAUDE report 18603349 ↗
• InjuryNov 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE. A HEAD, LINER, AND POLY INSERT WERE REVISED TO A STRYKER MDM LINER, A COMPETITOR POLY INSERT LOCKED INTO THE LINER, AND A COMPETITOR HEAD AND STEM. THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER OR HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 18198502 ↗
• InjuryNov 4, 2023Corroded; Corroded

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2013, AND WAS IMPLANTED WITH A ACCOLADE II HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD. HE WAS REVISED ON (B)(6) 2022, ALLEGEDLY DUE TO TRUNNION CORROSION.

  Patient problems: Insufficient Information

  MAUDE report 18070536 ↗
• InjurySep 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HIP REVISION FOR PERI-PROSTHETIC FRACTURE OF TRITANIUM/ACCOLADE 2 THR COMPLETED IN 2021. THE SURGEON ASSESSED THE ORIGINAL SHELL FIXATION AND LINER INTEGRITY. HE OBSERVED THE POLY LINER WAS HAVING INCREASED TRANSLATION WITHIN THE SHELL WITH MANUAL FORCE APPLIED. THE OLD POLY LINER WAS REMOVED AND A NEW REPLACEMENT LINER WAS INSERTED WHICH LOCKED IN SATISFACTORILY AND PROCEEDED TO CONTINUE ON WITH THE CASE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17762383 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRIDENT II STUDY, A CT SCAN IN THE FIRST POSTOPERATIVE WEEK REVEALED A LATERAL FEMORAL FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17018347 ↗
• InjuryApr 28, 2023Fracture; Fracture

  THE STEM FRACTURED AT THE NECK.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 16830187 ↗
• InjuryApr 6, 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), 2012 THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC FEMORAL HEAD AND ACCOLADE II STEM IN HER RIGHT HIP. IT IS FURTHER ALLEGED THAT THE PATIENT WAS REVISED ON (B)(6), 2021 WITH A PREOP DIAGNOSIS OF "HEAD NECK DISSOCIATION".

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16687893 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: REVISED A STEM AND HEAD DUE TO THIGH PAIN. NO ALLEGATIONS MADE AGAINST THE IMPLANTS.

  Patient problems: Pain

  MAUDE report 16680740 ↗
• InjuryDec 20, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO STEM SUBSIDENCE. A 32 -4 BIOLOX HEAD WAS REVISED TO A 32 +4 BIOLOX HEAD IN ORDER TO LENGTHEN THE CONSTRUCT TO COMPENSATE.

  Patient problems: Insufficient Information

  MAUDE report 16012858 ↗
• InjuryOct 20, 2022Fracture; Fracture

  FEMORAL FRACTURE. NO TREATMENT WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15638375 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION WAS PERFORMED DUE TO PERIPROSTHETIC FRACTURE." SPOKE TO REP. DURING PRIMARY PROCEDURE, SURGEON BROACHED FOR A SIZE 4 ACCOLADE STEM. AFTER TRIALING THE HEAD AND UPON (INTENTIONAL) DISLOCATION, THE STEM WAS OBSERVED TO BE LOOSE. PATIENT WAS INSPECTED FOR BONE FRACTURE, NONE WAS SEEN. SURGEON THEN BROACHED TO A 5, WHICH COUNTERSUNK DURING TRIALING OF THE STEM. SURGEON BROACHED TO A 6, WHICH HAD NO ISSUES, AND A SIZE 6 STEM WAS IMPLANTED. AN X-RAY TAKEN POST-OP WHILE THE PATIENT WAS IN THE RECOVERY ROOM SHOWED A FEMORAL FRACTURE. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A NEW FEMORAL HEAD. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 15577042 ↗
• InjuryAug 2, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE, WHICH CONTRIBUTED TO STEM SUBSIDENCE, WHICH CONTRIBUTED TO DISLOCATION OF THE HEAD FROM THE LINER. THE FEMORAL HEAD WAS REVISED TO ANOTHER HEAD AND SLEEVE WITH A LONGER NECK. STEM AND LINER WERE RETAINED.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 15144667 ↗
• InjuryJul 23, 2022Corroded; Material Erosion; Corroded; Material Erosion

  IT WAS REPORTED THAT THE "PATIENT UNDERWENT REVISION SURGERY TO REMOVE STEM/HEAD/POLY FROM TRIDENT/ACCOLADE TOTAL HIP. EXHIBITED PSEUDO TUMOR AND EVIDENCE OF TRUNNIONOSIS"

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 15090311 ↗
• InjuryJul 7, 2022Degraded; Unstable; Degraded; Unstable

  AS REPORTED VIA THE CONTACT US EMAIL FORM: IN (B)(6) OF 2018 I HAD BILATERAL TOTAL HIP REPLACEMENT WITH THE STRYKER TRIDENT PSL. IN APPROXIMATELY (B)(6) 2018 I STARTED EXPERIENCING SYMPTOMS IN MY RIGHT HIP. AT THE END OF JUNE X-RAYS CONFIRMED MECHANICAL FAILURE OF THE RIGHT HIP JOINT. I AM SCHEDULED FOR REVISION SURGERY ON (B)(6). I AM AWARE OF PAST STRYKER HIP RECALLS. WAS THIS PRODUCT RECALLED? DO YOU HAVE A CLAIMS PROCESS RELATED TO THE TYPE OF PRODUCT LIABILITY? UPDATE 13/JUNE/2022 WG: AS REPORTED IN MEDWATCH MW5109954: I WAS IN A DEEP SQUAT AND MY HIP REPLACEMENT FAILED AND SLIPPED OUT. I HAD A BILATERAL HIP REPLACEMENT WITH STRYKER TRIDENT PSL ON 2018. MY RIGHT HIP FAILED ABOUT 3-5 MONTHS LATER CAUSE UNKNOWN, RIGHT REVISION ON 2019. LEFT HIP FAILURE FROM A DEEP SQUAT WITH THE LEFT HIP REVISION SURGERY ON 2022. ADDITIONAL INFORMATION REPORTED: PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6) 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2018, PATIENT NOTICED INSTABILITY IN RIGHT HIP. PATIENT WAS REVISED IN (B)(6) 2019 DUE TO BROKEN POLY LINER. PATIENT MENTIONED "METAL ON METAL" AND ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT.

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

  MAUDE report 14952271 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: LEFT TOTAL HIP PERI PROSTHETIC FEMORAL FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 14951360 ↗
• InjuryJun 20, 2022Unstable; Unstable

  PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6) 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2018, PATIENT NOTICED INSTABILITY IN RIGHT HIP. PATIENT WAS REVISED IN (B)(6) 2019 DUE TO BROKEN POLY LINER. PATIENT MENTIONED "METAL ON METAL" AND ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT.

  Patient problems: Joint Laxity

  MAUDE report 14750389 ↗
• InjuryJun 16, 2022Material Erosion; Fracture; Material Erosion; Fracture

  I WAS IN A DEEP SQUAT, ONE I HAD DONE MANY TIMES BEFORE, AND MY IMPLANT FAILED AND SLIPPED OUT OF THE SOCKET. UPDATE PER CONVERSATION WITH PATIENT 05/25/2022: PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6) 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2022, PATIENT WAS IN A "DEEP SQUAT" AND THE LEFT HIP "FELL OUT TO THE BACK". PATIENT NOTED THAT PRIOR TO REVISION, SURGEON INDICATED POTENTIAL "STEM HITTING CUP AND LINER BREAKAGE" (PATIENT IS UNSURE IF LINER WAS METAL OR POLY). PATIENT ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT. PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2022. PATIENT HAS NOT RETURNED TO SURGEON YET FOR FOLLOW UP AND IS UNSURE AT THIS TIME WHAT PARTS WERE REVISED. PATIENT WILL SUPPLY MEDICAL RECORDS. UPDATE 13/JUNE/2022: AS REPORTED IN MEDWATCH MW5109954: I WAS IN A DEEP SQUAT AND MY HIP REPLACEMENT FAILED AND SLIPPED OUT. I HAD A BILATERAL HIP REPLACEMENT WITH STRYKER TRIDENT PSL ON 2018. MY RIGHT HIP FAILED ABOUT 3-5 MONTHS LATER CAUSE UNKNOWN, RIGHT REVISION ON 2019. LEFT HIP FAILURE FROM A DEEP SQUAT WITH THE LEFT HIP REVISION SURGERY ON 2022.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 14710818 ↗