Accolade 6721-0330Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 04546540669483), received between Feb 10, 2017 and May 1, 2026 — classified as 1 death, 51 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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 55 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Degraded; Fracture

  No new information.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 25054625 ↗
• MalfunctionApr 21, 2026Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: REPORTED BY THE DOCTOR: PATIENT S.H. UNDERWENT HIP ARTHROPLASTY WITH THE MAKO ROBOT - ON (B)(6) 2026 WITH THE PLACEMENT OF THE ACCOLADE II STEM. AFTER A FEW DAYS IN A POST-OPERATIVE CONSULTATION, IT WAS NOTICED THAT THERE WAS SINKING OF THE STEM.

  Patient problems: Insufficient Information

  MAUDE report 24936296 ↗
• InjuryMay 1, 2025Degraded; Degraded

  L) HIP REVISION TODAY DUE TO SUSPECTED TRUNIONOSIS. ORIGINAL SURGERY WAS L) HIP THA ON (B)(6) 2021. REVISION TODAY IN WHICH SURGEON FOUND BLACK DEBRIS AROUND FEMORAL NECK AND GROSS SEUDO TUMOUR AROUND SITE. REPLACED FEMORAL HEAD AND LINER.

  Patient problems: Foreign Body Reaction

  MAUDE report 21940912 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHONE CALL FROM DR ADVISING PT HAS A PPX R THR. ISSUE NOTICED FROM PAIN.

  Patient problems: Bone Fracture(s)

  MAUDE report 21446801 ↗
• InjurySep 10, 2024Corroded; Material Erosion; Corroded; Material Erosion

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2013 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM. ALLEGEDLY THE PATIENT DEVELOPED LATERAL HIP PAIN, HIGH COBALT-CHROME LEVELS AND MRI WAS CONSISTENT WITH A LARGE PSEUDOTUMOR. THE PATIENT WAS REVISED ON (B)(6) 2022 WITH A DIAGNOSIS OF ALTR/TAPER CORROSION.

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

  MAUDE report 20182227 ↗
• InjuryAug 8, 2024Corroded; Corroded

  PATIENTS LEFT HIP WAS REVISED FOR CUP MALPOSITIONING AND FLUID COLLECTION AROUND THE JOINT. UPON REMOVAL OF THE FEMORAL HEAD FROM THE STEM THERE WAS CONSIDERABLE CORROSION OF THE TRUNNION VISIBLE. A NEW CUP WAS POSITIONED IN THE ACETABULUM TO ELIMINATE FEMORAL COMPONENT IMPINGEMENT. THE CORROSION WAS CLEANED FROM THE STEM TRUNNION AND A V-40 TO C-TAPER ADAPTER SLEEVE WAS USED TO IMPLANT A C-TAPER CERAMIC HEAD WITH A MDM LINER.

  Patient problems: Insufficient Information

  MAUDE report 19939944 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRIDENT II STUDY, POSTOPERATIVELY FEMORAL FRACTURE WAS REPORTED. NO TREATMENT WAS PERFORMED FOR THIS FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 19349791 ↗
• InjuryApr 23, 2024Material Erosion; Material Erosion

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2013 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND AN ACCOLADE II HIP STEM. ALLEGEDLY IN THE LAST SEVERAL MONTHS SHE HAD INCREASING PAIN IN THE LEFT HIP, ELEVATED COBALT LEVEL SUGGESTING TRUNNIONOSIS AND WAS REVISED ON (B)(6) 2022.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19162769 ↗
• InjuryMar 19, 2024Corroded; Corroded

  IT WAS REPORTED, BY CLAIMANT'S COUNSEL. THAT ALLEGEDLY, THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE II STEM. SHE UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED TRUNNION CORROSION RIGHT HIP WITH ELEVATED METAL ION LEVELS AND PSEUDOTUMOR.

  Patient problems: Foreign Body Reaction

  MAUDE report 18935258 ↗
• InjuryAug 30, 2023Unintended Movement; Unintended Movement

  REVISED AN ACCOLADE II STEM /HEAD THAT SUBSIDED. HE UPSIZED FROM A 3 TO A 4. THERE WAS NO FRACTURE OF NOTE.

  Patient problems: Insufficient Information

  MAUDE report 17654133 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: INTRAOPERATIVE FEMUR FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17369916 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRIDENT II STUDY, A FEMORAL FRACTURE WAS IDENTIFIED POSTOPERATIVELY.

  Patient problems: Bone Fracture(s)

  MAUDE report 17347693 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT HAD HER FEMORAL STEM REVISED DUE TO PERIPROSTHETIC FRACTURE. RIGHT HIP. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY."

  Patient problems: Bone Fracture(s)

  MAUDE report 16662922 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. PATIENT HAD A PRIMARY TOTAL HIP IMPLANTED. WHILE TWISTING IN PT THE SAME DAY, PATIENT SUSTAINED A FEMORAL FRACTURE. PATIENT WAS REVISED THE SAME DAY. AN ACCOLADE II STEM AND BIOLOX HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH BIOLOX HEAD, AND THREE CABLE AND SLEEVE SETS. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 16625571 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THA FOR LEFT HIP ON (B)(6) 2021. A POSTOPERATIVE INFECTION WAS REPORTED ON JULY 16, 2021. PATIENT RECOVERED ON (B)(6) OF THE SAME YEAR.

  Patient problems: Unspecified Infection

  MAUDE report 16493530 ↗
• InjurySep 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISED A STRYKER RIGHT HIP DUE TO PERI-PROSTHETIC FRACTURE DUE TO A FALL. HE REVISED ALL COMPONENTS INCLUDING THE CUP AND LINER WITH COMPETITOR IMPLANTS. NO ALLEGATIONS MADE AGAINST THE IMPLANTS." SPOKE TO REP. PATIENT SUSTAINED A FEMORAL FRACTURE AFTER A FALL. THE SURGEON REPORTED HE WAS NOT CONFIDENT THAT THE SHELL WOULD HAVE REMAINED WELL-FIXED DUE TO THE FALL AND REVISED THE ENTIRE CONSTRUCT. NO ALLEGATIONS AGAINST THE REVISED HEAD OR LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 15461616 ↗
• InjuryAug 16, 2022Material Erosion; Material Erosion

  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) 2014. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF THE IMPLANTATION, ELEVATED COBALT LEVELS AND THE NEED FOR FURTHER SURGERY TO REPLACE THE STRYKER IMPLANTS.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 15231109 ↗
• InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A RIGHT HIP DUE TO INFECTION. STEM, HEAD AND LINER WERE SWAPPED.

  Patient problems: Unspecified Infection

  MAUDE report 14539869 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISED A STEM AND HEAD LEFT HIP ORIGINALLY DONE ON (B)(6) 2022 DUE TO PATIENT FALLING WITH A PERI-PROSTHETIC FRACTURE. HE REVISED TO A RESMOD." SPOKE TO REP. THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD OR ADM/MDM POLY INSERT. FEMORAL FRACTURE ADDRESSED WITH RESTORATION MODULAR STEM CONSTRUCT WITH A NEW FEMORAL HEAD AND ADM/ MDM POLY INSERT AND 3 CABLE AND SLEEVE SETS.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 13840617 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "RIGHT HIP REVISED DUE TO PERIPROSTHETIC FRACTURE. IMPLANTS NOT AVAILABLE TO BE RETURNED TO STRYKER, NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. EXTRACTED STEM AND HEAD. " SPOKE TO REP. THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD FOR THIS FEMORAL PERIPROSTHETIC FRACTURE REVISION.

  Patient problems: Bone Fracture(s)

  MAUDE report 13795941 ↗
• InjuryMar 4, 2022Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  DR. REVISED A LEFT TOTAL HIP ORIGINALLY DONE BY MAKO. THE STEM WAS NOT PUT IN CORRECTLY ORIGINALLY. THE CUP WASN'T FULLY STABLE WHEN ASSESSED. EVERYTHING WAS REPLACED WITH COMPETITOR COMPONENTS. NO ALLEGATIONS AGAINST THE IMPLANTS. UPDATE 10/FEBRUARY/2022 (B)(4): REP PROVIDED THE FOLLOWING RESPONSE WHEN ASKED IF THE SHELL WAS IMPLANTED IN THE POSITION IT WAS FOUND IN, OR IF IT HAD SHIFTED: "THE CUP WAS NOT SHIFTED AND WAS IN THE LOCATION AS PLANNED WITH MAKO. DR. USES A MANUAL REAMER WITH SMALLER SIZES UP THROUGH ONE UNDER, AND THEN USES MAKO FOR ONLY THE FINAL SIZE. IT WAS SUSPECTED THAT WAS THE CAUSE FOR THE CUP POSSIBLY NOT BEING FULLY SEATED AS IT'S POSSIBLE HE MANUALLY REAMED DEEPER THAN MAKO PLAN OR OFF CENTER."

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 13665796 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE. SURGEON REPORTED THE PATIENT HAD FALLEN SOME TIME BETWEEN THE PRIMARY IMPLANTATION 2 MONTHS PRIOR AND PRESENTING TO THE ER IMMEDIATELY BEFORE REVISION. THE FEMORAL STEM AND A FEMORAL HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 13564011 ↗
• InjuryJan 11, 2022Corroded; Corroded

  STATUS POST THA 18 MONTHS PRIOR, PATIENT HAD PAIN, PSEUDOTUMOR, AND ELEVATED COBALT LEVELS. PRE OP DIAGNOSIS WAS TRUNNION CORROSION WITH A 36 +10 LFIT V40 HEAD. UPON REVISION OF THE HEAD AND LINER THE TRUNNION AND HEAD SHOWED MILD CORROSION. STEM WAS RETAINED. LINER AND HEAD WERE REPLACED WITH A 32 D ECCENTRIC LINER, V40 TO C-TAPER ADAPTER SLEEVE, AND A 32MM +5 C-TAPER CERAMIC HEAD.

  Patient problems: Cancer; Foreign Body Reaction; Pain

  MAUDE report 13222164 ↗
• InjuryAug 12, 2021Insufficient Device Problem Information; 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 RIGHT HIP ON OR ABOUT (B)(6) 2018 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: Insufficient Information

  MAUDE report 12314435 ↗
• InjuryAug 10, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN. INTRA-OPERATIVELY, THE STEM WAS FOUND TO BE LOOSE, BUT THE SURGEON DECIDED TO REPLACE THE WHOLE CONSTRUCT. A SIZE 3 ACCOLADE II STEM, 36 + 2.5MM CERAMIC HEAD, NEUTRAL 36D LINER, AND 50D TRITANIUM SHELL WERE REPLACED WITH COMPETITOR DEVICES. REP CONFIRMED THAT HE CAN PROVIDE PICTURES, BUT OTHERWISE NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12299339 ↗