Accolade 6721-0230Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04546540669476), received between Apr 28, 2017 and Apr 23, 2024 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2024Degraded; Degraded

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2016 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND AN ACCOLADE II HIP STEM. SUBSEQUENTLY SHE PRESENTED WITH INCREASING PAIN AND WORKUP SHOWED ELEVATED COBALT AND CHROMIUM LEVELS. SHE WAS REVISED ON (B)(6) 2022.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19162860 ↗
• InjuryMar 19, 2024Degraded; Degraded

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE II STEM. SUBSEQUENTLY SHE ALLEGEDLY DEVELOPED PAIN AND SIGNS OF METALLOSIS THAT REQUIRED REVISION SURGERY ON (B)(6) 2022.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18935273 ↗
• InjuryFeb 12, 2024Degraded; Osseointegration Problem; Degraded; Osseointegration Problem

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017. IT IS ALLEGED THAT SHE BEGAN EXPERIENCING SEVERE HIP PAIN, BURNING PAIN WHEN SITTING AND SLEEPING, ALONG WITH CLICKING IN THE LEFT HIP. RADIOGRAPHS SHOWED ASEPTIC LOOSENING OF THE LEFT FEMORAL COMPONENT. WORKUPS COMPLETED REVEALED ELEVATED METAL LEVELS (ESR 38, CRP 19, COBALT AND CHROMIUM <1.0) AND A LEFT HIP ASPIRATION SHOWED THE GROWTH OF STAPH HOMINIS. ALLEGEDLY AS METALLOSIS WAS SUSPECTED, SHE UNDERWENT A LEFT TOTAL HIP REVISION ON (B)(6) 2020.

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

  MAUDE report 18683761 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: RIGHT TOTAL HIP. THE REVISION TODAY WAS SECONDARY TO POST-OP FEMUR FRACTURE. TODAY THE HEAD AND STEM WERE REMOVED AND A REST MOD STEM WITH HEAD WERE PLACED. COMPETITOR CABLES WERE USED FOR FRACTURE REDUCTION AND FIXATION. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Bone Fracture(s)

  MAUDE report 18468316 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE. A STEM AND HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD AND 4 CABLE AND SLEEVE SETS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 17187028 ↗
• InjuryAug 2, 2022Degraded; Degraded

  "TRUNNIONOSIS STEM BRACE 2 AND METAL HEAD 32MM +4MM."

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15146207 ↗
• InjuryJul 5, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED. AS REPORTED: "LEG LENGTH DISCREPANCY." A STEM, HEAD, AND LINER WERE REVISED. RIGHT SIDE.

  Patient problems: Insufficient Information; Unequal Limb Length

  MAUDE report 14914218 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISED A RIGHT TOTAL HIP DUE TO PERIPROSTHETIC FRACTURE FROM A FALL. REVISED TO RES MOD STEM. NO ALLEGATIONS MADE AGAINST THE IMPLANTS." REP CONFIRMED THE PATIENT'S FEMUR FRACTURED AND PROVIDED THE PRIMARY AND REVISION USAGE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 14237012 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INDEX RIGHT THA ON (B)(6) 2018. PATIENT PRESENTS WITH INCREASING PAIN AND ON X-RAYS SIGNS OF FEMORAL LOOSENING ARE SEEN. PATIENT UNDERGOES REVISION ON (B)(6) 2021. ONLY THE HEAD AND STEM ARE EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13690262 ↗
• InjuryNov 7, 2021Degraded; Unstable; Device Dislodged or Dislocated; Degraded; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED. ORIGINAL REASON FOR REVISION WAS DISSOCIATION OF THE LINER FROM THE SHELL. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: DEFORMATION OF THE LINER, METALLOSIS DUE TO IMPINGEMENT OF THE STEM ON THE SHELL, AND THE SURGEON REPORTED THE STEM WAS TOO SMALL FOR THE PATIENT'S ANATOMY (REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL STEM'S ACTUAL VS. REPORTED SIZE). THE STEM, HEAD, AND LINER WERE REVISED.

  Patient problems: Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology

  MAUDE report 12756241 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2019 THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH AN ACCOLADE II 127° NECK ANGLE HIP STEM AND A V40 FEMORAL HEAD WHICH RESULTED IN REVISION AND PERSONAL INJURIES. UPDATE: PER LEGAL, "THE ALLEGATIONS ARE FOR THE ACCOLADE II STEM AND THE V40 HEAD. CURRENTLY WE DO NOT KNOW WHY THE PATIENT WAS REVISED OR WHAT DEVICES WERE EXPLANTED."

  Patient problems: Insufficient Information

  MAUDE report 12022795 ↗
• InjurySep 11, 2018Migration; Migration

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO STEM SUBSIDENCE. ACCOLADE STEM, HEAD, AND ADM INSERT WERE REVISED TO AN HFX STEM, HEAD, AND ADM INSERT WITH CABLE, DISTAL CEMENT SPACER, AND CEMENT.

  Patient problems: Injury

  MAUDE report 7864684 ↗
• InjuryAug 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S RIGHT HIP WAS REVISED. REVISION IMPLANTS WERE A RESTORATION MODULAR STEM, 22.2 +0 LFIT HEAD, MDM/ADM LINER CONSTRUCT, AND ONE SCREW.

  Patient problems: Injury

  MAUDE report 7806483 ↗
• InjuryJul 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "THIS PATIENT WAS PARTICIPATING IN STRYKER'S RESTORATION ADM X3 STUDY. AS PER THE ADVERSE EVENT FORM, THE "PATIENT REPORTS PAIN IN OUTER ASPECT OF HIP. PHYSICIAN NOTES TROCHANTERIC TENDERNESS AND NO NEUROVASCULAR DEFICIT." THE HIP WAS ASPIRATED AND THERE WAS FOUND TO BE A RIGHT HIP INFECTION. AS PER THE OPERATIVE NOTES, THE PATIENT WAS REVISED DUE TO A "FAILED HIP REPLACEMENT SECONDARY TO IMPINGEMENT AND SEVERE METALLOSIS."" UPDATE (B)(6) 2018: PER REPORTER: "THE INFECTION WAS NEVER CLINICALLY CONFIRMED. THE INFECTION WAS SUSPECTED, BUT ENDED UP BEING THE METALLOSIS THAT IS MENTIONED."

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 7659116 ↗
• MalfunctionApr 28, 2017Inadequacy of Device Shape and/or Size; Device Operates Differently Than Expected; Device Operates Differently Than Expected

  SURGEON IMPLANTED ACCOLADE II STEM AND NOTICED IT SAT LOWER THAN THE BROACH. THE STEM WAS REMOVED AND A LARGER SIZE WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6532044 ↗