Accolade 6721-0635Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 04546540669513), received between Jan 5, 2017 and Apr 21, 2026 — classified as 50 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (19 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: AS PER PSS CASE: PERIPROSTHETIC LEFT ACETABULAR FRACTURE WITH ACETABULAR LOOSENING. HE ALSO HAS METALLOSIS AND LIKELY BONY NECROSIS MAKING A STANDARD HEMISPHERICAL COMPONENT LIKELY TO FAIL. SPOKE TO REP, REP WILL TRY TO GET ADDITIONAL PRODUCT INFORMATION WHEN THE REVISION IS PERFORMED (EXPECTED IN (B)(6) 2026). OTHERWISE, REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. ADDITIONAL INFORMATION RECEIVED 25-MAR-26, "THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR REVISION HIP SURGERY [ON (B)(6) 2026] FROM A PRIMARY HIP TO AN FDA AND IRB APPROVED STRYKER COMPASSIONATE USE PSS DEVICE. THE PATIENT'S PELVIS WAS REPORTED AS FRACTURED, AND IT REQUIRED THIS DEVICE ALONG WITH MULTIPLE SCREWS AND A RESTORATION MODULAR FEMORAL HIP STEM TO RESTORE STABILITY TO THE JOINT."

  Patient problems: Inadequate Osseointegration; Metal Related Pathology; Necrosis; Periprosthetic fracture

  MAUDE report 24941365 ↗
• InjuryApr 7, 2025Degraded; Material Erosion; Degraded; Material Erosion

  NO NEW INFORMATION.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 21785576 ↗
• InjuryDec 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2015 AND WAS IMPLANTED WITH AN LFIT V40 ANATOMIC FEMORAL HEAD AND ACCOLADE II HIP STEM. HE WAS REVISED ON (B)(6) 2022 ALLEGEDLY DUE TO PAIN, DIFFICULTY WITH FUNCTION, AND ELEVATED COBALT AND CHROME ION LEVELS.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 20913817 ↗
• InjuryJun 9, 2024Degraded; Degraded

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT THAT ON (B)(6) 2015 AND WAS IMPLANTED WITH AN LIFT V40 COCR FEMORAL HEAD AND ACCOLADE II HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2020, DUE TO ALLEGED METALLOSIS WITH STEM REVISION.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19495773 ↗
• InjuryJun 9, 2024Corroded; Degraded; Corroded; Degraded

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THAT ON (B)(6) 2016, AND WAS IMPLANTED WITH AN LIFT V40 COCR FEMORAL HEAD AND ACCOLADE II HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2021, DUE TO ALLEGED METALLOSIS AND CORROSION.

  Patient problems: Metal Related Pathology

  MAUDE report 19495770 ↗
• InjuryJun 3, 2024Corroded; Degraded; Corroded; Degraded

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2014, AND WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD AND AN ACCOLADE II HIP STEM AND WAS REVISED ON (B)(6) 2024. 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 19449058 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO A PERIPROSTHETIC FRACTURE AROUND THE STEM WAS PERFORMED. DURING THE REVISION SURGERY, AT THE SURGEON'S DISCRETION, THE STEM WAS PRESERVED AND ONLY THE HEAD WAS REPLACED. THE FRACTURE WAS FIXED WITH A PLATE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18922061 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE PATIENT'S FIRST REVISION. PATIENT HAD A PRIMARY (LEFT) HIP REPLACEMENT ON (B)(6) 2023. PATIENT SUBSEQUENTLY SUFFERED A FALL AND PERI PROSTHETIC FRACTURE. HE WAS REVISED TO RESTORATION MODULAR. SPOKE TO REP, WHO WAS NOT PRESENT FOR THE FIRST REVISION. IT IS UNKNOWN IF ANY STRYKER PERSONNEL WERE PRESENT FOR THE REVISION. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 18873860 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY COUNSEL THAT PATIENT UNDERWENT LEFT THA ON (B)(6) 2017, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM. HIS LEFT HIP WAS REVISED ON (B)(6) 2021, DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 18462786 ↗
• InjuryJan 4, 2024Material Erosion; Material Erosion

  IT WAS REPORTED BY COUNSEL THAT PATIENT UNDERWENT RIGHT THA ON (B)(6) 2015, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM. HIS RIGHT HIP WAS REVISED ON (B)(6) 2022, DUE TO PAIN AND ELEVATED METAL IONS IN HIS SERUM.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18444798 ↗
• InjuryNov 4, 2023Degraded; Material Erosion; Degraded; Material Erosion

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2014, AND WAS IMPLANTED WITH A ACCOLADE II HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD. HE WAS REVISED ON (B)(6) 2020 ALLEGEDLY DUE TO WEAKNESS AND PAIN, ELEVATED METAL IONS, AND ADVERSE SOFT TISSUE REACTION SECONDARY TO TRUNIONNOSIS.

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

  MAUDE report 18070553 ↗
• InjuryOct 5, 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) 2014, AND WAS REVISED ON (B)(6) 2023. IT IS FURTHER ALLEGED THAT THE PATIENT 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, THE REVISION OPERATIVE REPORT STATES THIS THA HAD DISLOCATED MULTIPLE TIMES NECESSITATING REVISION. INTRA-OPERATIVELY A GREAT DEAL OF METALLIC DEBRIS WAS ENCOUNTERED AS WELL AS A LARGE EFFUSION. UPON REMOVAL OF THE V-40 FEMORAL HEAD THE SURGEON REMARKED THE "TRUNNION WAS INTACT". COMPONENTS WERE "WELL FIXED". THE LINER WAS EXCHANGED TO ONE WITH AN ELEVATED RIM. A SLEEVE AND NEW HEAD WERE IMPLANTED.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 17874631 ↗
• InjuryAug 1, 2023Mechanical Problem; Inadequacy of Device Shape and/or Size; Mechanical Problem; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. PATIENT PRESENTED TO THE ER WITH A DISLOCATION. A CLOSED REDUCTION WAS ATTEMPTED AND WAS UNSUCCESSFUL. DURING THE REVISION, THE POLY INSERT WAS FOUND TO HAVE DISSOCIATED FROM THE FEMORAL HEAD AND DISLOCATED FROM THE METAL LINER. THE POLY INSERT, FEMORAL HEAD AND STEM WERE REVISED (STEM WAS REVISED TO ADD VERSION TO THE HIP CONSTRUCT). THE METAL LINER AND SHELL WERE RETAINED.

  Patient problems: Joint Dislocation

  MAUDE report 17438996 ↗
• InjuryJul 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A PROXIMAL FEMUR PERIPROSTHETIC FRACTURE. A HEMI HIP CONSTRUCT INCLUDING AN ACCOLADE II STEM WAS REMOVED, AND A HEMI HIP CONSTRUCT INCLUDING A RESTORATION MODULAR STEM CONSTRUCT WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 17284209 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT'S LEFT FEMUR STEM AND HEAD WERE REVISED DUE TO PERI PROSTHETIC FRACTURE AFTER A FALL. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17162265 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED DUE TO PERSISTENT PAIN ONE YEAR AFTER IMPLANT.

  Patient problems: Pain

  MAUDE report 17160746 ↗
• InjuryJun 6, 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 LEFT HIP ON OR ABOUT (B)(6) 2018 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 AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 17069486 ↗
• 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 15576919 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PLEASE FIND ATTACHED IMPLANT RECORD FOR INDEX AND REVISION SURGERIES OF LEFT TOTAL HIP. THE REVISION WAS DONE DUE TO A FALL AND PERIPROSTHETIC FRACTURE AROUND THE FEMORAL IMPLANT. NO FURTHER INFORMATION IS AVAILABLE FROM THE SURGEON OR HOSPITAL." A STEM, HEAD, AND LINER WERE REVISED.

  Patient problems: Bone Fracture(s)

  MAUDE report 14780538 ↗
• InjuryNov 23, 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 HIS RIGHT HIP ON OR ABOUT (B)(6) 2014 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 AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 12860275 ↗
• InjuryJun 30, 2021Adverse 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 PERIPROSTHETIC FRACTURE SUFFERED IN A FALL. AN ACCOLADE II STEM WAS REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST ANY REVISED IMPLANTS. REP ALSO CONFIRMED HE CAN PROVIDE PRIMARY AND REVISION USAGE, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. A SECOND REP ATTEMPTING TO REPORT THE SAME EVENT PROVIDED X-RAYS AND USAGE SHEETS, AND ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 12092659 ↗
• InjuryJun 23, 2021Migration; Migration

  AS REPORTED: "REVISED A RIGHT HIP DUE TO PERIPROSTHETIC FRACTURE AFTER THE PATIENT FELL. HE REVISED THE LINER, STEM AND HEAD TO A CONE/CONICAL WITH MDM." SPOKE TO REP, WHO CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, HEAD OR SLEEVE. REP PROVIDED PRIMARY AND REVISION USAGE, AN X-RAY, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 12048553 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BOOKED FOR OPEN REDUCTION INTERNAL FIXATION AND REVISION OF FEMORAL PROSTHESIS FOLLOWING A PERIPROSTHETIC FEMUR FRACTURE. THE FRACTURE OCCURRED THE EVENING FOLLOWING HER TOTAL HIP AS SHE ATTEMPTED TO SIT WITH THE ASSISTANCE OF A NURSE. DURING THE REVISION PROCEDURE IT WAS NOTED THAT THE 36E CROSSFIRE INSERT WAS MOVING WITHIN THE 52 MM TRIDENT PSL SHELL. THE SURGEON ELECTED TO REMOVE THE INSERT AND REVISE IT TO ANOTHER 36E INSERT. PRIOR TO IMPLANTING THE NEW INSERT THE SURGEON INSPECTED THE TRIDENT SHELL AND NOTED NO IRREGULARITIES. HE THEN IMPACTED THE NEW LINER AND CONFIRMED IT WAS FULLY SEATED AND LOCKED IN THE SHELL.

  Patient problems: Bone Fracture(s)

  MAUDE report 11063175 ↗
• InjurySep 15, 2020Mechanical Problem; Fitting Problem; Loss of Osseointegration; Insufficient Device Problem Information; Migration; Mechanical Problem; Fitting Problem; Loss of Osseointegration; Insufficient Device Problem Information; Migration

  SUBJECT REPORTED ANTERIOR HIP PAIN WITH SIGNIFICANT LIMP ON (B)(6) 2019. PER SUBJECT, EXPERIENCING SAME PAIN AND ISSUES AS BEFORE SURGERY. EVENT IS UNRESOLVED AND ONGOING. SUBJECT INSTRUCTED TO LIMIT WEIGHT BEARING ACTIVITIES WHILE WALKING. UPDATE 26/AUGUST/2020 WG: ADDITIONAL INFORMATION PROVIDED BY STUDY SITE: "(B)(6) 2019 CLINIC NOTES INDICATE SOME "MILD DISCOMFORT" BUT "NOTHING SIGNIFICANT." HOWEVER, (B)(6) 2019 NOTES INDICATE "SIGNIFICANT THIGH PAIN" ABOUT "3 WEEKS AGO," FROM YARD WORK...FROM (B)(6) 2019 THROUGH PRESENT IN EMR, THIS EVENT IS DIAGNOSED AS STEM SUBSIDENCE...XRAY REVIEWS NOTED STEM SUBSIDENCE AND OSSIFICATION (B)(6) 2019. CT: POSSIBLE LACK OF INGROWTH W HYPERTROPHY AROUND STEM...PARTIAL WEIGHT BEARING WITH WALKER, STOP P.T... (B)(6) 2019, (B)(6) 2019 , & (B)(6) 2019 NOTES INDICATE PAIN BUT SUBJ CONTINUES TO AMBULATE AND PERFORM ADLS... (B)(6) 2020 XRAYS: FURTHER SUBSIDENCE "UNABLE TO WALK ANY DISTANCE."...(B)(6) 2020 NOTES: ASEPTIC LOOSENING CONFIRMED...REVISION PLANNED (B)(6) 2020."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 10538577 ↗
• InjurySep 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. NO POSSIBLE CAUSE OR CONTRIBUTOR FOR PAIN WAS REPORTED TO THE REP. AN ACCOLADE II STEM, BIOLOX HEAD, AND A 32D POLY LINER WERE REVISED TO RESTORATION MODULAR STEM CONSTRUCT, FEMORAL HEAD, ADM/MDM POLY INSERT, AND MDM LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Pain

  MAUDE report 10499242 ↗