Accolade 6721-0535Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 04546540669506), received between Jan 12, 2017 and Mar 3, 2026 — classified as 81 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (28 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 84 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Degraded

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2017 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD WHICH WAS REVISED ON (B)(6) 2024 DUE TO ALLEGED ELEVATED METAL IONS AND METALLOSIS.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 24494534 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A STEM AND HEAD OF A LEFT HIP DUE TO PERIPROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 22139471 ↗
• InjuryNov 24, 2024Degraded; Degraded

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2013 AND WAS IMPLANTED WITH A LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE II HIP STEM. SUBSEQUENTLY HE DEVELOPED PERSISTENT PAIN WHICH ALLEGEDLY WAS PAINFUL WITH WALKING, WITH WEIGHTBEARING AND HAD PAIN WITH RANGE OF MOTION IN HIS HIP. HE WAS REVISED ON (B)(6) 2020, AND INTRAOPERATIVELY THE SURGEON NOTED CHEESY PASTE-LIKE MATERIAL IN HIS JOINT AND SOME METALLOSIS BETWEEN THE FEMORAL HEAD AND THE TRUNNION.

  Patient problems: Foreign Body Reaction

  MAUDE report 20768689 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT HIP. PATIENT REVISED DUE TO PERIPROSTHETIC FRACTURE. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Bone Fracture(s)

  MAUDE report 20391164 ↗
• InjurySep 17, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REVISION "IN THE FUTURE (REASON UNKNOWN).". AS REPORTED IN PI (B)(6): PATIENT RECEIVED PRIMARY THA. THE THA WAS REVISED IN THE FUTURE (REASON UNKNOWN) RESTORATION MODULAR AND MDM. PATIENT THEN HAD A DIS ASSOCIATION OF MDM AFTER THE FIRST REVISION. PATIENT WAS BROUGHT BACK TO THE OR ON (B)(6) 2024 FOR MDM REVISION. UPDATE PER MEDICAL RECORDS RECEIVED: THE PATIENT WAS REVISED DUE TO LEG LENGTH DISCREPANCY WHEREBY THE LEFT LEG WAS 15MM LONGER THAN THE RIGHT. THE STEM, HEAD, AND MDM/ADM POLY LINER WERE REVISED, AND A RESTORATION MODULAR STEM CONSTRUCT WAS IMPLANTED.

  Patient problems: Insufficient Information; Unequal Limb Length

  MAUDE report 20235961 ↗
• InjuryJun 5, 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. AFTER A FALL, PATIENT HAD PAIN. SURGEON REPORTED THAT DUE TO PATIENT'S USE OF FOSAMAX, THERE WAS CONCERN OF IMPENDING FRACTURE. THE FEMORAL STEM AND HEAD WERE REVISED TO COMPETITOR IMPLANTS, PROPHYLACTICALLY AGAINST FRACTURE. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall; Pain

  MAUDE report 19467155 ↗
• InjuryMay 15, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO RECURRENT DISLOCATIONS. A STEM, HEAD, AND LINER WERE REVISED. AS REPORTED BY REP: "THE LINER SEPARATED FROM THE SHELL, THE HEAD FROM THE LINER, AND THE HEAD FROM THE STEM. THE DATE OF THE PREVIOUS SURGERY IS THE ONLY INFORMATION I DO NOT HAVE BUT CAN BE OBTAINED FROM THE HOSPITAL."

  Patient problems: Joint Dislocation

  MAUDE report 19325934 ↗
• InjuryMay 8, 2024Loss of Osseointegration; Loss of Osseointegration

  PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. ON (B)(6) 2022, REVISION SURGERY WAS PERFORMED AND STEM AND HEAD WAS REPLACED DUE TO STEM LOOSENING ASSOCIATED WITH PERI-STEM FRACTURE. PRODUCT INFORMATION DETAIL IS UNAVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19267756 ↗
• InjuryMar 19, 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 FEMORAL FRACTURE. THE STEM, HEAD, AND LINER WERE REVISED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 18935303 ↗
• InjuryJan 5, 2024Degraded; Degraded

  IT WAS REPORTED BY COUNSEL THAT PATIENT UNDERWENT RIGHT THA ON (B)(6) 2016 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND AN ACCOLADE II HIP STEM. HE WAS REVISED ON (B)(6) 2021, DUE TO PAIN, ELEVATED CHROMIUM AND COBALT LEVELS AND TRUNNIONOSIS.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18449793 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A LEFT HIP STEM AND HEAD DUE TO PERI-PROSTHETIC FRACTURE.

  Patient problems: Hip Fracture

  MAUDE report 18299475 ↗
• InjuryNov 28, 2023Corroded; Material Erosion; Adverse Event Without Identified Device or Use Problem; Corroded; Material Erosion; Adverse Event Without Identified Device or Use Problem

  PATIENT'S WIFE REPORTED HUSBAND EXPERIENCING BURSITIS ON RIGHT HIP AND MAY REQUIRE A REVISION. PATIENT REPORTED HAVING SURGERY ON THE SURROUNDING TISSUE BUT NO IMPLANTS WERE EXPLANTED. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL.

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

  MAUDE report 18214442 ↗
• InjuryNov 4, 2023Degraded; Degraded

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2016, AND WAS IMPLANTED WITH A ACCOLADE II HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD. SHE WAS REVISED ON (B)(6) 2022 ALLEGEDLY DUE TO CHRONIC PAIN, ELEVATED COBALT LEVELS AND METALLOSIS.

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

  MAUDE report 18070547 ↗
• InjuryOct 9, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO STEM LOOSENING (SURGEON SUSPECTS LOOSENING WAS CAUSED BY A FEMORAL FRACTURE SUSTAINED IN A FALL). THE STEM AND HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 17893053 ↗
• InjurySep 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT THA REVISION OF PERI-PROSTHETIC FRACTURE. EXPLANTED STEM AND RESMOD INSERTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 17762382 ↗
• InjuryJun 6, 2023Degraded; Degraded

  AS REPORTED: "DR. PERFORMED A RIGHT HIP REV DUE TO ALTR." A HEAD, LINER, AND SHELL WERE REVISED.

  Patient problems: Foreign Body Reaction

  MAUDE report 17076216 ↗
• InjuryMay 23, 2023Material Erosion; Fracture; Material Erosion; Fracture

  THIS IS FOR STEM 1 OF 2 LEFT HIP THE STEM NECK ON BOTH SIDES HAVE BEEN SHAVED OFF. FUTURE TREATMENT PLAN IS CURRENTLY UNDER CONSIDERATION. PATIENT HAD PAIN AND RESTRICTION OF ACTIVITIES UPDATE PER MEDICAL REVIEW: "... GIVEN THE POSITION OF THE ACETABULAR COMPONENTS THIS MAY WELL BE DUE TO IMPINGEMENT OF THE FEMORAL NECK ON THE ACETABULAR COMPONENT."

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 16982491 ↗
• InjuryMay 22, 2023Material Erosion; Material Erosion

  THIS IS FOR STEM 2 OF 2. THE STEM NECK ON BOTH SIDES HAVE BEEN SHAVED OFF. FUTURE TREATMENT PLAN IS CURRENTLY UNDER CONSIDERATION.

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 16974358 ↗
• InjuryJan 30, 2023Corroded; Device Dislodged or Dislocated; Corroded; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD ON HER LEFT HIP ON (B)(6) 2014. IT IS FURTHER ALLEGED THAT THE SUBJECT PRODUCTS MALFUNCTIONED AND/OR DISLODGED CAUSING INJURIES TO PATIENT, INCLUDING BUT NOT LIMITED TO ELEVATED COBALT LEVELS AND THE NEED FOR FURTHER SURGERY TO REPLACE THE STRYKER IMPLANTS.

  Patient problems: Bacterial Infection; Foreign Body Reaction; Inadequate Osseointegration; Metal Related Pathology; Pain

  MAUDE report 16265607 ↗
• InjuryDec 20, 2022Corroded; Corroded

  AS REPORTED: "HEAD & LINER WERE EXCHANGED DURING AN IRRIGATION AND DEBRIDEMENT MEANT FOR INFECTION. STRIPE WEAR PRESENT ON CERAMIC & LINER. SURGEON REPORTED CORROSION PRESENT ON NECK/TRUNNION OF FEMORAL STEM".

  Patient problems: Unspecified Infection

  MAUDE report 16013360 ↗
• InjuryDec 4, 2022Migration; Migration

  AS REPORTED: "REVISED A RIGHT HIP DUE TO STEM SUBSIDENCE AND SUBSEQUENT DISLOCATION. HE KEPT THE STEM IN AND REVISED THE LINER AND HEAD TO MDM WITH A +12 HEAD." REP CONFIRMED THAT THE HEAD DISLOCATED FROM THE LINER.

  Patient problems: Joint Dislocation

  MAUDE report 15912628 ↗
• InjuryOct 31, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO STEM LOOSENING. A STEM, HEAD AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A NEW HEAD AND LINER. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD OR LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15698097 ↗
• InjurySep 12, 2022Adverse 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. AN ACCOLADE II STEM AND BIOLOX HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, ANOTHER BIOLOX HEAD, AND 3 CABLE AND SLEEVE SETS. 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 15406564 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "INDEX AND REVISION SURGERY FOR A RIGHT TOTAL HIP. THE PATIENT SAID THEY MIS-STEPPED AND FELT A POP. THE STEM WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE AROUND THE ORIGINAL IMPLANT." REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 13505740 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration

  PATIENT HAD REVISION SURGEON AFTER PRESENTING IN EMERGENCY 2/52 POST OP FOLLOWING A FALL. PATIENT HAS A PERI PROSTHETIC FRACTURE OF THE FEMUR. RESTORATION MODULAR STEM IMPLANTED, ACETABULAR LINER CHANGED. DALL MILES CABLES APPLIED TO FRACTURE SITE. RIGHT SIDE. UPDATE (B)(6) 2021: RESPONSE NOTED: "WAS IT NOTED WHY A CULTURE EXAMINATION WAS REQUIRED? THERE SMALL AREA OF OOZE NOTED AT THE DISTAL END OF THE WOUND"

  Patient problems: Bone Fracture(s); Fall; Hip Fracture; Purulent Discharge

  MAUDE report 13102528 ↗