Accolade 6720-0535Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 04546540664488), received between Apr 28, 2017 and May 28, 2026 — classified as 37 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Material Erosion

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2015 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM WHICH WAS REVISED ON (B)(6) 2025 DUE TO ALLEGED PSEUDOTUMOR AND TRUNNIONOSIS.

  Patient problems: Insufficient Information

  MAUDE report 25315845 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A RIGHT TOTAL HIP DUE TO (COMPETITOR) CUP LOOSENING AND INFECTION. OUR STEM AND HEAD WHERE USED IN THE ORIGINAL SURGERY. CUP AND LINER WERE NOT STRYKER. THE STEM WAS KEPT IN THIS REVISION AND WE REVISED THE HEAD, LINER, AND CUP TO A UNITRAX UNIPOLAR HEAD WITH A SLEEVE. THIS WILL BE USED AS A TEMPORARY ANTIBIOTIC SPACER UNTIL INFECTION CLEARS.

  Patient problems: Unspecified Infection

  MAUDE report 23616156 ↗
• InjuryFeb 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY SALE REP THAT THE REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2024 DUE TO PATIENT X-RAY SHOWS DISLOCATED AFTER THE PRIMARY SURGERY. THE ADM X3 DISLOCATED FROM THE MDM METAL LINER. THE SURGICAL TREATMENT FOR THE DISEASE IS STEM REPLACEMENT. THE REVISION SURGERY WAS PERFORMED AND REINSERTED INTO THE PATIENT EXCEPT THE STEM AS THE ORIGINAL STEM SIZE WAS UNABLE TO BE USED.

  Patient problems: Joint Dislocation

  MAUDE report 21320259 ↗
• InjuryDec 11, 2024Degraded; Degraded

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT 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) 2023 ALLEGEDLY DUE TO INCREASING PAIN AND ELEVATED COBALT LEVELS.

  Patient problems: Foreign Body Reaction

  MAUDE report 20909799 ↗
• InjurySep 6, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Osseointegration Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Osseointegration Problem

  THE HIP JOINT DISLOCATED, AND A REVISION WAS NECESSARY. THE PATIENT HAD A UHR HEAD AND AN ACCOLADE II STEM. INTRAOPERATIVELY, IT TURNED OUT THAT THE HEAD WAS NOT HELD ON THE STEM, AND THE OPERATOR REMOVED THE HEAD FROM THE STEM CONE WITHOUT ANY RESISTANCE. AFTER REMOVING THE HEAD AND STEM, STIMULAN WAS USED BECAUSE THE PATIENT HAD AN INFECTION.

  Patient problems: Inadequate Osseointegration; Joint Dislocation; Periprosthetic fracture; Unspecified Infection

  MAUDE report 20155279 ↗
• InjuryJul 11, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE STEM. THE STEM AND THE HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD, AND PROVIDED ALL INFORMATION AVAILABLE FROM THE HOSPITAL AND SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19727111 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A STEM AND HEAD OF A RIGHT HIP DUE TO PER-PROSTHETIC FRACTURE THAT OCCURRED POST-OP DAY 2.

  Patient problems: Bone Fracture(s)

  MAUDE report 18207944 ↗
• InjuryOct 30, 2023Corroded; Corroded

  PATIENT HAD AN INDEX RIGHT THA ON (B)(6) 2021. PATIENT PRESENTED WITH RIGHT HIP PAIN AND SQUEAKING. PATIENT UNDERWENT REVISION ON (B)(6) 2022. SOME CORROSION WAS FOUND ON THE TAPER-HEAD UNION. ALL COMPONENTS WERE EXCHANGED EXCEPT THE FEMORAL STEM.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 18035814 ↗
• InjuryNov 23, 2022Adverse 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 ON (B)(6) 2015 THE PATIENT WAS IMPLANTED WITH AN ACCOLADE II STEM IN HIS LEFT HIP. IT IS FURTHER ALLEGED THAT THE PATIENT STARTED TO EXPERIENCE PAIN AND DISCOMFORT, THE PAIN WORSENED AND ON (B)(6) 2020 REVISION SURGERY WAS PERFORMED.

  Patient problems: Discomfort; Pain

  MAUDE report 15851030 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY THA ON (B)(6) 2021. THE PATIENT DEVELOPED AN INFECTION OF THE RIGHT HIP AND UNDERWENT REVISION FOR PJI WITH ALL COMPONENTS EXCHANGED EXCEPT CUP ON (B)(6) 2021. THE PATIENT DIED ON (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 15317060 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL HIP LESSER TROCHANTER FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15293612 ↗
• InjuryMay 4, 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 A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL. A STEM AND HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 14274143 ↗
• InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR...REVISED A [LEFT HIP] STEM AND HEAD DUE TO FEMORAL FRACTURE. ORIGINAL SURGERY WAS (B)(6) 2021.

  Patient problems: Bone Fracture(s)

  MAUDE report 12346825 ↗
• InjuryAug 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO FEMORAL PERI-PROSTHETIC FRACTURE. PATIENT WAS REVISED FROM AN ACCOLADE II STEM, BIOLOX DELTA CERAMIC HEAD, AND ADM / MDM INSERT TO A COMPETITOR HEAD AND STEM WITH A NEW ADM / MDM INSERT. REP CONFIRMED THAT THERE ARE 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 12318421 ↗
• InjuryAug 13, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2016 THE PATIENT UNDERWENT SURGERY OF THE RIGHT HIP AND WAS IMPLANTED A STRYKER TOTAL HIP SYSTEM. IT IS FURTHER ALLEGED THAT ON OR ABOUT (B)(6) 2021 THE PATIENT COMPLAINED OF A STABBING AND RADIATING PAIN IN HIS RIGHT HIP, STIFFNESS, WEAKNESS, LIMITED RANGE OF MOTION AND MOBILITY AND WORSENING PAIN WITH ACTIVITY. THE PATIENT WAS REVISED ON OR ABOUT (B)(6) 2021 AND ALLEGEDLY THE SURGEON INTRAOPERATIVELY NOTED "PSEUDOTUMOR, TRUNNIONOSIS, BLACK STAINED TISSUE AND ADVERSE LOCAL TISSUE REACTION" AND "CUP WAS BROKEN LOOSE WITH MINIMAL EFFORT" AND THERE WAS NO BONY INGROWTH. THE SHELL, LINER AND FEMORAL HEAD WERE REMOVED AND REPLACED.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Loss of Range of Motion; Pain

  MAUDE report 12317361 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION RIGHT TOTAL HIP ARTHROPLASTY, FEMORAL COMPONENT." ORIF. PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. AN ACCOLADE II STEM AND BIOLOX DELTA V40 CERAMIC HEAD WERE REVISED. SPOKE TO REP: (B)(4) HIP. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST ANY IMPLANTS BEING MALPOSITIONED OR AGAINST THE REVISED HEAD. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 11847861 ↗
• InjuryMar 17, 2021Degraded; Material Erosion; Degraded; Material Erosion

  AS REPORTED: "DR. PERFORMED A LEFT HIP REVISION DUE TO GROSS TRUNNION FAILURE AND FRACTURED BIOLOX HEAD. NO MORE INFORMATION IS AVAILABLE PER DOCTOR. IMPLANT IS NOT AVAILABLE PER HOSPITAL POLICY" A 36 + 2.5 MM BIOLOX CERAMIC V40 HEAD, SIZE 5 132° ACCOLADE II HIP STEM, AND 36F LINER WERE REVISED. SPOKE TO REP: THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. CONFIRMED THAT OTHER THAN ATTACHED EXPLANT PICTURES AND USAGE SHEET, NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 11509662 ↗
• InjuryMar 4, 2021Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  (B)(6)2017 : BHA WAS DONE FOR FEMORAL NECK FRACTURE. (B)(6)2017 : INFECTION OCCURRED AND DRAINAGE WAS PERFORMED. THE DOCTOR DETERMINED THAT THE NO CAUSAL RELATIONSHIP WITH THE DEVICE. PATIENT WAS RECOVERED.

  Patient problems: Unspecified Infection

  MAUDE report 11413215 ↗
• InjuryFeb 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "THIS PATIENT¿S (LEFT) HIP IS BEING REVISE DUE TO THIGH PAIN. SURGEON STATED PREOP X-RAY LOOKED 'VERY GOOD'." REP PROVIDED PRIMARY AND REVISION USAGE AND A PRE-REVISION X-RAY AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11332297 ↗
• InjuryNov 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "DR. DID A LEFT HIP REVISION. REASON FOR REVISION WAS FEMORAL PERIPROSTHETIC HIP FRACTURE. NO MORE INFORMATION IS AVAILABLE PER DOCTOR. IMPLANTS ARE NOT AVAILABLE DUE TO HOSPITAL POLICY." SPOKE TO REP, WHO PROVIDED THE PRIMARY USAGE SHEET. AN ACCOLADE II STEM AND BIOLOX HEAD WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 10872445 ↗
• InjuryAug 27, 2020Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY (B)(6) 2020. X-RAYS DEMONSTRATED AN UNSTABLE PERIPROSTHETIC FEMORAL FRACTURE (B2). PATIENT UNDERWENT REVISION OF LEFT HIP, ALL COMPONENTS EXCHANGED EXCEPT CUP (AND SCREWS) (B)(6) 2020.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10459556 ↗
• InjuryJan 23, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  ON (B)(6) 2019 THE PATIENT WAS FELT AND RIGHT FEMORAL NECK FRACTURE OCCURRED. (B)(6) 2019 TREATED WITH IMPLANTING THE STEM BY SURGICAL PROCEDURE. (B)(6) 2019 TREATED MANUALLY DUE TO DISLOCATION. (B)(6) 2019 THE PATIENT WAS DISCHARGED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9624159 ↗
• InjuryOct 4, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AND LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2013 AND WAS REVISED ON (B)(6) 2018. 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: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 9155851 ↗
• InjuryMay 21, 2019Migration; Migration

  REP REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A SUBSIDED STEM. PATIENT WAS REVISED TO RESTORATION MODULAR 21+10 CONE STEM AND 56+5 CERAMIC HEAD. NO FURTHER INFORMATION WILL BE PROVIDED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 8627580 ↗
• MalfunctionApr 4, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN A SURGEON OPENED THE INNER BLISTER PACKAGE, HE NOTICED A FOREIGN MATERIAL IN THE PACKAGE. A SPARE STEM WAS USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483897 ↗