Accolade 6020-0435Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04546540510563), received between Jun 21, 2018 and May 27, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Degraded” (9 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2012 AND WAS IMPLANTED WITH LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM THAT WAS SUBSEQUENTLY REVISED ON (B)(6) 2023 DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 25306922 ↗
• InjuryAug 12, 2024Material Erosion; Loss of Osseointegration; Material Erosion; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "HEAD AND STEM ARE LOOSE." AN ACCOLADE STEM AND LFIT HEAD WERE REVISED TO A BIOLOX HEAD AND RESTORATION MODULAR STEM CONSTRUCT. UPDATE PER MEDICAL REVIEW: THE PREOPERATIVE X-RAY DID SHOW ECCENTRICITY OF THE HEAD NECK JUNCTION BUT DID NOT SHOW FRANK LOOSENING OF THE STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19967720 ↗
• InjuryJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2009, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2023, DUE TO ALLEGED HEAD DISSOCIATION.

  Patient problems: Joint Dislocation

  MAUDE report 19689515 ↗
• InjurySep 11, 2023Degraded; Fracture; Detachment of Device or Device Component; Degraded; Fracture; Detachment of Device or Device Component

  PRIMARY THA SURGERY WAS DONE AT (B)(6) 2011. UNABLE TO WALK DUE TO BROKEN IMPLANT. REVISION SURGERY IS SCHEDULED AT (B)(6) 2023. UPDATED INFORMATION: A MONTH AGO, HE STAGGERED AND FELL ON A FISHING BOAT, AND SINCE THEN HE HAS BEEN FEELING DISCOMFORT FROM HIS HIP TO HIS RIGHT HIP. (B)(6) WHEN I GOT UP FROM MY CHAIR, MY LEGS FELT WOBBLY. WHEN HE LAY DOWN AND TRIED TO GET UP, HE DEVELOPED PAIN IN HIS RIGHT HIP AND HAD DIFFICULTY MOVING. AS A RESULT OF A VISIT TO THE PRIMARY CARE PHYSICIAN, A THA DISLOCATION WAS FOUND AND THE PATIENT WAS TRANSFERRED TO THE MAIN HOSPITAL.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 17726527 ↗
• InjuryJul 19, 2023Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  THIS PI IS FOR THE REVISION OF THE PATIENT'S LEFT HIP. THE DEVICES WERE IMPLANTED INTO THE PATIENT'S LEFT HIP ON (B)(6), 2010. TRUNNION BETWEEN THE HEAD AND THE NECK WAS WORN AND METALLOSIS WAS CONFIRMED AND REVISION SURGERY WAS PERFORMED ON (B)(6), 2023. THE PATIENT WAS A TRUCK DRIVER, SO THE DOCTOR COMMENTS THAT LOAD MAY BE APPLIED TO THE DEVICES WHEN THE PATIENT GOT ON AND OFF THE TRUCK. THE DEVICES WERE NOT RETURNED FOR INSPECTION.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 17350152 ↗
• InjuryJun 28, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  DID UNCEMENTED HIP SURGERY BEFORE 10 YRS AND NOW HIP STEM IMPLANT IS DAMAGE AND DISLOCATION IN HIP. UPDATE: X-RAYS AND PICTURES PROVIDED SHOW THE HEAD DISSOCIATED FROM THE STEM.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 17222202 ↗
• InjuryMar 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY IN (B)(6) OF 2011 AN LFIT ANATOMIC V40 FEMORAL HEAD WAS IMPLANTED IN THE PATIENT'S RIGHT HIP AND THE PATIENT WAS REVISED ON (B)(6), 2021. STRYKER WAS MADE AWARE OF THIS EVENT VIA LEGAL COUNSEL. UPDATE AS PER MED REVIEW DATED 17 FEBRUARY 2023: REVISION SURGERY FOR DISSOCIATION OF A COCR LFIT V40 HEAD FROM AN ACCOLADE TMZF STEM APPROXIMATELY 10 YEARS AFTER THE INDEX PROCEDURE. THE CUP WAS AT A HIGH ABDUCTION ANGLE OF HIGH 500 RANGE ON X-RAY.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16492350 ↗
• InjuryOct 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT PRESENT WITH A DISLOCATED HIP. UPON REVISING THE COMPONENTS, IT WAS NOTED THAT THE HIP PROSTHESIS (ACCOLADE TMZF) WAS DAMAGED. THE NECK TAPER WAS VISIBLY DEFECTIVE AS IT WAS SHEARED DOWN TO A POINT. THE STEM WAS REMOVED AND THE HIP WAS REVISED. THE PATIENT AND SURGEON BOTH ASKED FOR THIS TO BE DOCUMENTED. RIGHT HIP UPDATE: "THE HEAD STAYED IN THE LINER BUT THE NECK OF THE STEM CAME OUT OF THE HEAD."

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Pain

  MAUDE report 15572689 ↗
• InjuryAug 26, 2022Fracture; Fracture

  PATIENT IS A 68 YEAR OLD MALE WHO UNDERWENT SURGERY ON (B)(6) 2010 FOR A LEFT TOTAL HIP ARTHROPLASTY, PRESENTED WITH PAIN AND X-RAYS SHOWED A FEMORAL HEAD DISSOCIATION FROM THE TRUNNION OF THE STEM AS WELL AS THE TRUNNION FRACTURING OFF THE NECK OF THE BODY OF THE STEM AND FLOATING FREE IN THE JOINT SPACE. THE ORIGINAL STRYKER IMPLANTS IMPLANTED WERE: ACCOLADE TMZF SIZE 4X132 STEM, A 36-5 V40 COCR FEMORAL HEAD, A SIZE 54 TRIDENT HA HEMISPHERICAL ACETABULAR SHELL, AND TWO SCREWS, AND SIZE 36 E NEUTRAL X3 POLYETHYLENE LINER. NO IMPLANT RECORD AVAILABLE FOR THE FIRST SURGERY. THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM, A REVISION HIP WAS PERFORMED ON THE LEFT SIDE, THE TRUNNION WAS FRACTURED FROM THE STEM, THE HEAD WAS FREE IN THE ACETABULUM CAUSING IMPINGEMENT AND METALLOSIS. THERE WAS ADVERSE LOCAL TISSUE REACTIONS FROM THE TRUNNIONOSIS HOWEVER THE ADDUCTORS WERE IN TACT. ANOTHER COMPANY'S REVISION STEM WAS USED, THE TRIDENT CUP WAS RETAINED AND A NEW 36MM SIZE E 10 DEGREE LINER WAS PUT INTO THE CUP.

  Patient problems: Foreign Body Reaction

  MAUDE report 15300188 ↗
• InjuryJun 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE TRUNNION BREAKING OFF FROM THE STEM (REPORTED AS 'RIGHT AT THE BEGINNING OF THE TRUNNION) INSIDE THE HEAD. THE HEAD, STEM, AND LINER WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 14826747 ↗
• InjuryJun 7, 2022Degraded; Material Erosion; Degraded; 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 RIGHT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2022. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 14615937 ↗
• InjurySep 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2011. ALLEGEDLY THE PATIENT HAD DEVELOPED WORSENING HIP PAIN TO THE POINT THAT HE HAS BECOME NON-AMBULATORY FOR THE PAST 4 WEEKS. X-RAYS REVEALED DISSOCIATION OF THE FEMORAL HEAD FROM THE FEMORAL STEM AND DISLOCATION OF THE JOINT. HE WAS REVISED ON (B)(6) 2021.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 12497222 ↗
• InjuryDec 15, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT'S ALLEGED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY IN 2007 WHERE HE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. IT IS FURTHER ALLEGED THAT THE PATIENT BEGAN TO EXPERIENCE PAIN AND CLICKING WITH MOVEMENT. X-RAYS PERFORMED ON (B)(6) 2019 REVEALED SEVERE TRUNNION FAILURE. BLOOD WORK ALSO REVEALED ELEVATED LEVELS OF COBALT. THIS RESULTED IN THE PATIENT TO UNDERGO RIGHT HIP REVISION SURGERY ON (B)(6) 2020.

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

  MAUDE report 11011211 ↗
• InjuryAug 11, 2020Fracture; Fracture

  THE PATIENT HAD A TOTAL HIP REPLACEMENT IN 2008, RECENTLY FELL AND SAW THE DOCTOR. THE X-RAYS REVEALED AN APPARENT FAILURE OF THE NECK OF THE FEMORAL STEM. THE DOCTOR ELECTED TO REVISE THE PROSTHESIS. SURGERY REVEALED THAT THE NECK OF THE FEMORAL STEM WAS BROKEN. THE ACETABULAR COMPONENT WAS RETAINED, THE ACETABULAR LINER WAS REVISED, THE FEMORAL STEM WAS REMOVED AND REVISED USING THE RESTORATION MODULAR SYSTEM.

  Patient problems: Ambulation or Postural Difficulties; Fall; Injury

  MAUDE report 10390657 ↗
• InjuryFeb 14, 2020Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION OF THE FEMORAL HEAD FROM THE STEM. INTRA- OPERATIVELY, TRUNNIONOSIS AND BLACK TISSUE WERE NOTED. PATIENT'S STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, AND AN ADM/ MDM LINER CONSTRUCT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Injury

  MAUDE report 9711664 ↗
• InjuryFeb 11, 2020Degraded; Loss of Osseointegration; Osseointegration Problem; Degraded; Loss of Osseointegration; Osseointegration Problem

  PATIENT CALLED STATING HE HAD A RIGHT HIP REPLACEMENT DONE ON (B)(6) 2008 AND IS EXPERIENCING PAIN AS HE WALKS. PATIENT ALSO REPORTED THAT HIS DOCTOR MENTIONED BONE LOSS AND LOOSENING IN HIS HIP. PATIENT WOULD LIKE TO KNOW IF HIS IMPLANTS WERE PART OF A RECALL.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Inadequate Osseointegration; Osteolysis; Pain

  MAUDE report 9693266 ↗
• InjuryNov 5, 2019Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  TRUNNION DAMAGE TO THE ACCOLADE TMZF STEM. ON (B)(6) 2019; UPDATED INFO FROM REP. DAMAGE WAS ASSUMED TO BE FROM THE MITCH TRH MODULAR HEAD. DAMAGE NOTICED INSIDE THE PATIENT, ON X-RAY. STEM WAS IMPLANTED (IN 2007). REVISION SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 9278436 ↗
• InjuryAug 5, 2019Degraded; Degraded

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED. INITIALLY, PATIENT COMPLAINED OF PAIN AND ELEVATED LEVELS OF COBALT AND CHROMIUM WERE NOTED. PRE- REVISION X-RAYS REVEALED THE PRESENCE OF TRUNNIONOSIS. INTRA-OPERATIVELY, A MODERATE AMOUNT OF BLACK TISSUE WAS OBSERVED, AS WELL AS STEM-LINER IMPINGEMENT. THE ACCOLADE STEM, LFIT V40 HEAD, AND POLY LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A NEW HEAD AND LINER. REP PROVIDED THE REVISION USAGE SHEET, PRE-REVISION X-RAY, INTRA-OP PHOTO, AND PHOTOS OF THE EXPLANTS AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE. UPDATE (B)(6) 2019 - AS PER MED REVIEW COMMENT X-RAY CONFIRMS DISASSOCIATION BETWEEN HEAD AND STEM.

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 8860293 ↗
• InjuryMay 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DEVICES WERE RECEIVED WITH A MOSTLY BLANK PERFORM AND X-RAYS OF A PATIENT'S RIGHT HIP. AN ACCOLADE STEM, LFIT V40 40 -4 HEAD, AND POLY LINER WERE RECEIVED. THE PER FORM HAS THE FOLLOWING INFORMATION: DATE OF IMPLANT (B)(6) 2010, DATE OF EXPLANT (B)(6) 2019, REVISION OF PRIMARY, SURGICAL APPROACH TRADITIONAL/ STANDARD, PATIENT'S POST IMPLANT ACTIVITY LEVEL MODERATE, COMPLICATING CONDITIONS "CKD, HEPATITIS, HYPERLIPIDEMIA". UPDATE 13 JUNE 2019: INFORMATION RECEIVED FROM SALES REP: THE SURGEON IS ONLY LOOKING FOR A VOLUMETRIC WEAR ANALYSIS ON THE POLY. HE DOES NOT HAVE A PRODUCT COMPLAINT.

  Patient problems: Injury

  MAUDE report 8595562 ↗
• InjuryJan 23, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE ATTORNEY THAT PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2017 DUE TO ALLEGED HEAD DISASSOCIATION (HD).

  Patient problems: Injury

  MAUDE report 8272539 ↗
• InjuryJan 11, 2019Corroded; Device Dislodged or Dislocated; Material Deformation; Corroded; Device Dislodged or Dislocated; Material Deformation

  END USER HAS REPORTED THAT THERE WAS SEVERE ACCOLADE TAPER CORROSION FOR THE PATIENT, THEY REVISED THE STEM AND USED CONE CONICAL AS A REVISION STEM. THEY'VE NOTICED THE MENTIONED PROBLEM FROM THE PATIENT'S X RAY AND DURING THE SURGERY THEY NOTICED THE ACTUAL IMPLANT WITH THE PROBLEM . FOR THE OTHER CASE THAT HAS BEEN STATED THAT HAPPENED ABOUT 9 MONTHS AGO, HAS BEEN OPENED. UPDATE 19 MAR 2019: THIS PI IS FOR THE PATIENT'S LEFT HIP. UPDATE 19 AUGUST 2019: COMMENTS PROVIDED BY CONSULTING CLINICIAN HAVE INDICATED: THE X-RAYS CONFIRM THE EVENT WITH CATASTROPHIC TRUNNION FAILURE WITH A LOT OF METALLIC DEBRIS IN AND AROUND THE JOINT ON BOTH SIDES. THE LEFT FEMORAL HEAD HAS DISASSOCIATED FROM THE REMAINING STEM TRUNNION THAT HAS MAJOR METAL SUBSTANCE LOSS AND CONSEQUENT LOSS OF TAPER LOCK FUNCTIONALITY.

  Patient problems: Injury

  MAUDE report 8239756 ↗
• InjuryDec 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT'S LAWYER REPORTS THAT IN 2008, FOLLOWING SECONDARY HIP ARTHROSIS, THE PATIENT UNDERWENT LEFT HIP ARTHRO-PROSTHETIC SURGERY. FOLLOWING THIS IMPLANTATION, PROBLEMS OF AMBULATION OCCURRED, AND ALTERATION OF BLOOD CHEMISTRY WITH PRESENCE OF COBALT IN THE BLOOD.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Reaction

  MAUDE report 8130823 ↗
• InjurySep 28, 2018Degraded; Material Deformation; Degraded; Material Deformation

  ON (B)(6) 2011 A REVISION OF THE RIGHT TOTAL HIP WAS PERFORMED FOR RIGHT HIP INSTABILITY WITH DISASSOCIATION FEMORAL HEAD FROM STEM. THE FINDINGS WERE METAL STAINING SYNOVIUM, SYNOVIAL FLUID AND PSEUDOCAPSULE. FEMORAL HEAD DISASSOCIATED. DAMAGE TO POLY LINER WITH FULL THICKNESS WEAR AND MINIMAL DAMAGE TO SHELL. SUPERIOR SCRATCHES ON THE TRUNNION SIGNIFICANTLY, IT WASN'T POSSIBLE TO ATTACHED A NEW HEAD.

  Patient problems: Inflammation; Injury; Joint Dislocation; Reaction

  MAUDE report 7919041 ↗
• InjurySep 4, 2018Material Deformation; Material Deformation

  ORIGINAL OP DATE (B)(6) 2008 / OP. RIGHT HIP. ACCOLADE TMZF ¿ MITCH. IN 2017 PATIENT HAD A TROCHANTERIC FRACTURE WHILE GETTING UP FROM BED. EVERYTHING LOOKED GOOD AND HE WAS DECIDED TO TREAT CONSERVATIVELY. HIP STAYED SORE AND PATIENT COULDN'T MOVE SO REVISION OPERATION WAS DECIDED. HIP JOINT WAS BLACK WHEN OPENED. 52MM STANDARD MITCH HEAD WAS REMOVED AND ACCOLADE TRUNNION WAS VISUALLY DAMAGED INSIDE THE HEAD. AT THAT POINT, IT WAS DECIDED TO REMOVE THE STEM AND REPLACED IT WITH A COMPETITOR, REVISION STEM. CUP 58MM WAS WELL FIXED AND IN GOOD ORIENTATION SO IT WAS LEFT IN PLACE. REMOVED ACCOLADE STEM IS SIZE 4.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Injury

  MAUDE report 7844132 ↗
• InjuryJun 26, 2018Degraded; Degraded

  ON (B)(6) 2010, THE PATIENT UNDERWENT THA SURGERY WITH ACCOLADE TMZF, METAL HEAD V40 AND TRIDENT CUP 52 MM. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 DUE TO SUSPICION OF ASEPTIC LOOSENING OF THE CUP. DURING REVISION SURGERY, METALLOSIS AND TRUNNIONOSIS WERE OBSERVED ON THE TRUNNION SECTION OF ACCOLADE TMZF AND THE METAL HEAD. THE TRIDENT CUP AND THE METAL HEAD WERE REPLACED WITH NON-STRYKER CUP AND DELTA CERAMIC HEAD.

  Patient problems: Inadequate Osseointegration; Injury; Reaction

  MAUDE report 7637192 ↗