Accolade 6721-0937Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540669544), received between Apr 25, 2019 and Nov 26, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Degraded” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Degraded; Degraded

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 23657484 ↗
• InjuryApr 4, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "PT. PRESENTED WITH A SUBSIDED ACC2 HIP STEM WHICH LEAD TO HIP DISLOCATION, ORIGINAL THA ON (B)(6) 2022. OPTED TO REVISE THE STEM AND CHANGE THE X3 LINER AND BIOLOX HEAD COMBINATION TO AN MDM CONSTRUCT." REP PROVIDED PRIMARY AND REVISION USAGE SHEETS. SPOKE TO REP, WHO CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE (B)(6) 2022 WG: REP RE-CONFIRMED THAT THE FEMORAL HEAD DID DISLOCATE OUT OF THE LINER AS A RESULT OF STEM SUBSIDENCE.

  Patient problems: Insufficient Information

  MAUDE report 14003745 ↗
• InjuryFeb 14, 2022Corroded; Corroded

  IT WAS REPORTED BY PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT DURING THE REVISION SURGERY THE SURGEON OBSERVED TRUNNION CORROSION REACTION AND A PSEUDOTUMOR.

  Patient problems: Cancer; Foreign Body Reaction

  MAUDE report 13521656 ↗
• InjuryOct 7, 2020Material Erosion; Loss of Osseointegration; Material Erosion; Loss of Osseointegration

  THE FOLLOWING WAS REPORTED: I HAD THA REVISION SURGERY IN 2018. THE STEM WAS REPLACED WITH A STRYKER RESTORATION MODULAR ONE. THE 28 MM CERAMIC FEMORAL HEAD WAS REPLACED WITH A COCR HEAD. HIP, GROIN, AND THIGH PAIN CONTINUED. IN 2019, I WAS DIAGNOSED WITH A STRESS FRACTURE AT THE TIP OF THE PROSTHETIC STEM. IN 2020, I HAD A BONE GRAFT TO REPAIR THE FRACTURE. A CLOUDY MILKY YELLOW FLUID ALONG WITH METAL DEBRIS WAS DISCOVERED IN THE HIP JOINT. ALSO, THERE WAS OSTEOLYSIS IN THE PROXIMAL FEMORAL FEMUR. THE ACETABULAR HAD OVERHANGING SCAR TISSUE AND BONE. THE TRUNION HAD STRIPE WEAR INDICATING IMPINGEMENT AND LIKELY SOURCE OF THE METALLOSIS. THE 28 MM FEMORAL HEAD WAS REPLACED WITH A 40MM COCR HEAD. SYMPTOMS OF METALLOSIS CONTINUE. UPDATE: AS PER THE PATIENT, HE HAD A LEFT THA ON (B)(6) 2016. HE STARTED TO EXPERIENCE PAIN AT THE END OF (B)(6) 2016. THE PATIENT HAD A BONE SCAN DONE ON (B)(6) 2017 (APPROX.) WHICH INDICATED INFECTION/IMPLANT LOOSENING. NO TREATMENT WAS GIVEN TO THE PATIENT. ON (B)(6) 2017 (APPROX.) HE WAS PLACED ON ORAL ANTIBIOTICS FOR 30 DAYS DUE TO INFECTION. ON (B)(6) 2017 X-RAYS CONFIRMED LOOSENING AND THE PATIENT WAS REVISED ON (B)(6) 2018. PATIENT CONTINUED TO EXPERI

  Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection

  MAUDE report 10641222 ↗
• InjuryAug 21, 2020Fracture; Fracture

  DR. REVISED A HIP LINER, HEAD AND STEM TO A RES MOD CONE/ CONICAL WITH 36 HEAD AND INSERT DUE TO PERI-PROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10436707 ↗
• InjuryAug 3, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM. THE PATIENT'S STEM, HEAD, AND LINER WERE REVISED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, AND PROVIDED THE PRIMARY AND REVISION USAGE. REP CAN PROVIDE PICTURES, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 10354988 ↗
• InjuryApr 25, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2014 WHERE HE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. IT IS FURTHER ALLEGED THAT DIAGNOSTIC WORKUP REVEALED EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HIS BLOOD. THE PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2018.

  Patient problems: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 8550992 ↗