Accolade 6020-0230Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04546540510549), received between Nov 21, 2018 and Aug 26, 2025 — classified as 26 injuries.

The most frequently reported specific device problem is “Degraded” (11 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.

• InjuryAug 26, 2025Fracture; Noise, Audible; Fracture; Noise, Audible

  A PATIENT REPORTS THAT THIS MODEL OF PROSTHESIS WAS IMPLANTED IN 2010. HE STATES THAT HE HAS ATTENDED ALL ANNUAL CHECK-UPS AND EVERYTHING WAS FINE, INCLUDING IN 2025. IN MAY, WHILE GETTING UP FROM A CHAIR, HE HEARD A ¿CRACK¿ AND WAS UNABLE TO WALK. HE WENT TO THE EMERGENCY ROOM AND WAS TOLD THAT IT WAS LOWER BACK PAIN. AS IT DID NOT SUBSIDE, HE WENT TO THE ORTHOPEDIC SURGEON WHO PREVIOUSLY OPERATED ON HIM AND ORDERED AN X-RAY OF HIS HIP AND A CT SCAN OF HIS LOWER BACK. THE X-RAYS SHOWED AN IMAGE OF THE NECK OF THE STEM BENT, AND HE WAS TOLD THAT IT WAS BROKEN. HE WAS SENT FOR A 3D CT SCAN, AND THE RESULTS CONFIRMED THE SAME THING. NOW HE HAS TO HAVE ANOTHER PRIVATE OPERATION TO HAVE IT REPLACED.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain

  MAUDE report 22899102 ↗
• InjuryMay 2, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE IS AN UPCOMING ACCOLADE REVISION SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21950252 ↗
• InjuryApr 2, 2025Material Erosion; Material Erosion

  IT WAS REPORTED THROUGH COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT A LEFT THA AND WAS IMPLANTED WITH A COCR FEMORAL HEAD AND AN ACCOLADE TMZF HIP STEM. SHE WAS SUBSEQUENTLY REVISED ON B)(6) 2024, DUE TO ALLEGED PAIN AND XRAY FINDINGS CONCERNING FOR ALTR.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 21750923 ↗
• InjuryNov 4, 2024Degraded; Fracture; Degraded; Fracture

  AS REPORTED: "DR. CONTACTED ME LAST NIGHT STATING THAT THIS TMZF/LFIT FEMORAL HEAD HAD TRUNNIONOSIS AND THE NECK OF THE FEMORAL STEM HAD FRACTURED. HE IS REVISING THE STEM TODAY ((B)(6) 2024)." RIGHT HIP. SURGEON IS INQUIRING IF ANY IMPLANTS WERE RECALLED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 20598119 ↗
• InjuryMay 15, 2024Material Erosion; Material Erosion

  THA REVISION. REVISED A 14 YEAR OLD SIZE 2 127° ACCOLADE TMZF STEM WITH A 36 +5 LFIT HEAD. HEAD HAD TRUNNIONOSIS AND FELL OFF THE STEM. IT HAD TO BE REVISED. IT WAS REVISED TO A REST MOD STEM. KEPT CUP AND DID AN MDM LINER SIZE E WITH A 28+4 CERAMIC HEAD. 18X155 STEM WITH 23+0 BODY.

  Patient problems: Insufficient Information

  MAUDE report 19319029 ↗
• InjuryApr 2, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO HEAD DISSOCIATION. INTRA-OPERATIVELY, EXCESSIVE WEAR WAS NOTED OF THE TRUNNION. THE STEM, HEAD AND LINER WERE REVISED TO A COMPETITOR STEM, HEAD, AND DUAL MOBILITY POLY WITH A STRYKER MDM LINER. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19018507 ↗
• InjuryNov 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6)2008, AND WAS IMPLANTED WITH A ACCOLADE TMZF HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD. SHE WAS REVISED ON (B)(6) 2022, ALLEGEDLY DUE TO HEAD DISASSOCIATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 18098606 ↗
• InjuryNov 11, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PT. SCHEDULED FOR RIGHT REVISION HIP. RES MOD 115 STEM, 19+20 CONE BODY REPLACED ACCOLADE 1 SIZE 2 FEMORAL STEM.36 METAL HEAD REMOVED IN CONJUNCTION WITH 36 ELEVATED RIM PLOY INSERT. ORIGINAL ACETABULAR CUP REMAINED IN PATIENT. CONVERTED 36 ELEVATED POLY LINER TO MDM SHELL/LINER WITH 28+4 BIOLOX CERAMIC HEAD. METALLOSIS COULD BE EVIDENT BASED OFF INCISION EXPOSURE OF HIP JOINT TISSUE/BONE AND WEAR ON FEMORAL IMPLANT NECK TRUNNION.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 15785314 ↗
• InjuryAug 1, 2022Degraded; Degraded

  IT WAS REPORTED THROUGH COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD AND WAS REVISED DUE TO ALLEGED PSEUDOTUMOR AND TRUNNIONOSIS.

  Patient problems: Cancer

  MAUDE report 15137409 ↗
• InjuryJan 31, 2022Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION HIP SURGERY DUE TO A DISSOCIATION BETWEEN THE HEAD AND FEMORAL STEM AND THE SUBSTANTIAL DAMAGE TO THE FEMORAL TRUNION. IT WAS FURTHER REPORTED THAT THE REVISION WAS PERFORMED AFTER THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH A DISLOCATION THAT APPEARED UNUSUAL ON XRAY >10 YEARS POST HIP REPLACEMENT.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 13392230 ↗
• InjuryDec 9, 2021Degraded; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Degraded; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  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 LEFT HIP ON OR ABOUT (B)(6) 2007 AND WAS REVISED ON (B)(6) 2020. 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: Ambulation or Postural Difficulties; Insufficient Information; Metal Related Pathology

  MAUDE report 12972996 ↗
• InjuryJul 13, 2021Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component

  MEDICAL ASSISTANT FOR A SURGEON CALLED INQUIRING IF THE ACCOLADE TMZF STEM WAS PART OF A RECALL. IMPLANT INFORMATION FOR THE PATIENT'S HIP HAS BEEN REQUESTED. IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN IN THE LEFT HIP. UPDATE ON (B)(6) 2021 WG: AS REPORTED BY THE MEDICAL ASSISTANT: "...THE DEVICE BROKE AND THE PATIENT IS BEING TAKEN TO SURGERY TODAY."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12157330 ↗
• InjuryApr 15, 2021Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD ON (B)(6) 2008 AND SUBSEQUENTLY DEVELOPED SEVERE PAIN IN THE RIGHT HIP AND THE INABILITY TO WALK OR BEAR WEIGHT ON THE RIGHT LEG, A LARGE PSEUDOTUMOR, DISASSOCIATION BETWEEN THE FEMORAL HEAD AND NECK AND METALLOSIS. IT IS FURTHER ALLEGED THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 11674827 ↗
• InjuryNov 6, 2020Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO GROSS TRUNNION FAILURE. THE FEMORAL HEAD WAS REPORTED TO BE TOGGLING ON THE WORN DOWN TRUNNION, AND BLACK TISSUE WAS NOTED. THE PATIENT'S ENTIRE HIP CONSTRUCT WAS REVISED IN ORDER FOR THE SURGEON TO CLEAR ALL METAL DEBRIS FROM THE JOINT. THE REP CAN PROVIDE ADDITIONAL PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation; Metal Related Pathology

  MAUDE report 10799892 ↗
• InjuryOct 30, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. AN ALUMINA HEAD AND LINER, ACCOLADE STEM, AND COMPETITOR CABLES AND PLATES WERE REVISED. REP PROVIDED EXPLANT PICTURES AND REVISION USAGE SHEET, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 10763697 ↗
• InjuryJul 22, 2020Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  AS REPORTED: "PRE-OP DIAGNOSIS: MECHANICAL COMPLICATION OF PROSTHETIC JOINT IMPLANT, INITIAL ENCOUNTER. MECHANICAL FAILURE OF LEFT HIP REPLACEMENT CONFIRMED BY DOCTOR INTRA-OP (HEAD-STEM JUNCTION)...NO FURTHER INFORMATION AVAILABLE PER HOSPITAL."

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 10307933 ↗
• InjuryJul 3, 2020Material Erosion; Material Erosion

  TYPICAL CONE CORRUSION WITH V40 CONE AND METAL HEAD SIZE 36 ACCORDING TO KNOWN PROBLEMS IN THE LITERATURE. PRESENCE OF A MASSIVE PSEUDOTUMOUR INCLUDING THE ARTIFICIAL HIP JOINT FROM THE OS ILIUM TO THE TROCHANTER MINOR OF THE FEMUR, AS WELL AS VIA THE FORAMEN ISCHIADICUM INTO THE SMALL PELVIS WITH AN EXTENSION OF APPROX. 5X5 CM ACCORDING TO MRI. NECESSARY REVISION WITH PSEUDOTUMOUR REMOVAL AND HEAD EXCHANGE (SPECIAL ADAPTER).

  Patient problems: Injury

  MAUDE report 10229309 ↗
• InjuryApr 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "DOCTOR SAID REVISION NOT RELATED TO IMPLANTS. LOOSE PROSTHESIS FROM FALL." PATIENT'S STEM, HEAD AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED DEVICES, PROVIDED A PRE-REVISION X-RAY, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Injury

  MAUDE report 9918205 ↗
• InjuryNov 5, 2019Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  AS REPORTED: "[LEFT HIP] REVISION SURGERY. REVISED HEAD BALL, LINER, DOME HOLE PLUG, SCREW AND STEM. ACETABULAR CUP WAS LEFT AND INSPECTED - DEEMED INTACT. NEW LINER AND DOME HOLE PLUG IMPLANTED. HEAD WAS DISASSOCIATED OFF TRUNNION. STEM WAS UNUSUALLY WORN DOWN. STEM REVISED AND EXPLANTED AS WELL AS HEAD. UNUSUAL WEAR ON STEM TRUNNION". REP PROVIDED PRE- AND POST-REVISION X-RAYS, AN EXCERPT OF THE OPERATIVE REPORT, AND PICTURES OF THE EXPLANTS. THE LINER PICTURED SHOWS A NOTICEABLY DAMAGED RIM IN ONE SPOT. SPOKE TO REP. LINER WAS IN THAT CONDITION IN VIVO. THE DEVICES ARE ALLEGEDLY AVAILABLE FOR RETURN, BUT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 9278164 ↗
• InjurySep 30, 2019Degraded; Degraded

  IT WAS REPORTED THE PATIENT'S HIP WAS REVISED DUE TO PAIN. THE SURGEON REPORTED THAT PRE-REVISION X- RAYS APPEARED TO SHOW THE HEAD COLLAPSED ON THE STEM. INTRA-OPERATIVELY, METALLOSIS AND TRUNNION WEAR WERE NOTED. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A COCR HEAD AND MDM/ADM LINER CONSTRUCT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, AND PROVIDED EXPLANT PICTURES. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 9134961 ↗
• InjurySep 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PAIN & SHORTENING LEG. X-RAY REVEALED HEAD [DISASSOCIATED] FROM STEM. ALL AVAILABLE INFORMATION SUBMITTED." PATIENT WAS REVISED TO "RESTORATION W/ MDM". REP PROVIDED EXPLANT PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 9109042 ↗
• InjuryJun 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO ELEVATED SERUM ION LEVELS. REP REPORTED THAT THE PATIENT WAS OTHERWISE ASYMPTOMATIC, AND NO INTRA-OPERATIVE FINDINGS WERE REPORTED TO THE REP. THE HEAD AND LINER WERE EXCHANGED (THERE ARE NO ALLEGATIONS AGAINST THE POLY LINER) FOR A CERAMIC HEAD WITH SLEEVE AND ANOTHER POLY LINER. REP PROVIDED PRIMARY IMPLANT INFORMATION AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8670202 ↗
• InjuryApr 17, 2019Break; Material Erosion; Break; Material Erosion

  FEMORAL NECK ON AN ACCOLADE TMZF ERODED AND BROKE.

  Patient problems: Injury

  MAUDE report 8522534 ↗
• InjuryApr 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. PATIENT ALSO HAD ELEVATED ION LEVELS (SURGEON REPORTED HIGH ION LEVELS COULD HAVE BEEN THE RESULT OF THE PATIENT HAVING BILATERAL KNEE REPLACEMENTS AND BILATERAL HIP REPLACEMENTS). SURGEON NOTED THE CUP WAS MALPOSITIONED AT IMPLANTATION (70° INCLINATION), AND ALSO THAT THE FEMORAL AND ACETABULAR COMPONENTS WERE WELL-FIXED. INTRA-OPERATIVELY, SOME CORROSION WAS NOTED IN THE HEAD/ TRUNNION INTERFACE, BUT THERE WAS NO DISCOLORATION OF FLUID OR TISSUE NOTED. THE SHELL, LINER, AND HEAD WERE REVISED TO A TRIDENT II REVISION SHELL, POLY LINER, AND A CERAMIC FEMORAL HEAD WITH SLEEVE. REP CONFIRMED THERE WERE ABSOLUTELY NO ALLEGATIONS AGAINST THE LINER (WEAR, DISCOLORATION, ETC). REP PROVIDED THE PRIMARY IMPLANT SHEET, X-RAYS, EXPLANT AND INTRA-OP PICTURES AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 8471954 ↗
• InjuryFeb 25, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

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

  MAUDE report 8367222 ↗