Accolade 6720-0635Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 04546540664495), received between Mar 2, 2017 and May 18, 2026 — classified as 36 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (18 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO AN EXTENDED FEMUR FRACTURE (FRACTURE EXTENDED DOWN THE FEMUR). THE ENTIRE HEMI HIP CONSTRUCT WAS REMOVED AND A NEW HEMI HIP WITH A RESTORATION MODULAR STEM CONSTRUCT WAS IMPLANTED. REP WILL TRY TO OBTAIN ORIGINAL IMPLANT INFORMATION AND RETURN THE EXPLANTS, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 25200861 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "ONGOING HIP PAIN IN CORRELATION WITH PHYSICAL MOVEMENTS."

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 22462212 ↗
• InjuryApr 28, 2025Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT "DURING A THA ACCOLADE CASE TODAY, WE ENCOUNTERED AN ISSUE WITH A SIZE 6, 132 OFFSET STEM. THE IMPLANT APPEARED TO SIT APPROXIMATELY 4MM HIGHER THAN THE TRIAL. FOLLOWING IMPLANTATION, THE FEMUR FRACTURED¿THOUGH IT¿S UNCLEAR IF THIS WAS DIRECTLY RELATED. WE OPENED A SECOND SIZE 6, 132 OFFSET STEM, WHICH FIT LINE-TO-LINE WITH THE TRIAL"

  Patient problems: Bone Fracture(s)

  MAUDE report 21922039 ↗
• InjuryFeb 6, 2025Material Erosion; Material Erosion

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2021 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE II STEM. HE WAS REVISED ON (B)(6) 2023 DUE TO ALLEGED METALLOSIS.

  Patient problems: Foreign Body Reaction

  MAUDE report 21321408 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE. AN ACCOLADE II STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, FEMORAL HEAD, ADM/MDM POLY INSERT, AND MDM METAL LINER. SURGEON REPORTED LINER CONVERSION WAS DONE PROPHYLACTICALLY AGAINST POSSIBLE DISLOCATION, THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 19173248 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II STEM. HE UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED ADVERSE LOCAL TISSUE REACTION.

  Patient problems: Foreign Body Reaction

  MAUDE report 18928295 ↗
• InjuryFeb 28, 2024Fracture; Fracture

  REVISED A LEFT HIP DUE TO PERI-PROSTHETIC FRACTURE. SHE REVISED THE STEM AND HEAD.

  Patient problems: Insufficient Information

  MAUDE report 18795441 ↗
• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL AND FRACTURED THE PERI-STEM AND FEMUR FRACTURE ON THE OPPOSITE SIDE. CONSERVATIVE TREATMENT ON (B)(6) 2021. UPDATE: PRIMARY SURGERY WAS DONE FOR THE RIGHT SIDE FEMORAL NECK FRACTURE. AFTER SURGERY PATIENT FELL, FEMUR FRACTURE ON THE LEFT SIDE AND FRACTURED THE AROUND STEM ON RIGHT SIDE WERE OCCURRED.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 16443581 ↗
• InjuryJun 28, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY CAUSED BY INCORRECT SELECTION (IMPLANTS WERE TOO SHORT/ DID NOT HAVE ENOUGH OFFSET FOR PATIENT'S ANATOMY). REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE IMPLANTS. AN ACCOLADE II STEM AND BIOLOX HEAD WERE REVISED. REP CONFIRMED THAT PRIMARY USAGE MAY BE ABLE TO BE PROVIDED, OTHERWISE, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14839306 ↗
• InjuryMay 14, 2022Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT, HE HAD A RIGHT THA DONE IN DEC 21, 2020. PATIENT STARTED TO EXPERIENCE PAIN APPROX. THREE MONTHS AFTER HIS SURGERY. THE PATIENT IS ALSO EXPERIENCING POPPING, SWELLING AND LEG DISCREPANCY. THE PATIENT HAS AN UPCOMING REVISION SURGERY SCHEDULED FOR (B)(6). PATIENT WANTS ASSISTANCE IN GETTING BETTER. UPDATE AS PER MED REVIEW, X-RAYS TAKEN ON THAT DATE SHOWED "WHAT APPEAR TO BE A RADIOLUCENCY AROUND THE POROUS COATING LATERALLY AND MEDIALLY AND THE STEM APPEARS TO HAVE SUNK SLIGHTLY. THERE IS THE BEGINNING OF A PEDESTAL AT THE DISTAL TIP OF THE STEM IMMEDIATELY AND LATERALLY." THE SOCKET APPEARED WELL FIXED. IT WAS FELT THAT THE PATIENT'S PAIN WAS RELATED TO LOOSENING OF THE FEMORAL STEM AND A WORKUP WAS PERFORMED INCLUDING TO RULE OUT INFECTION.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 14403176 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF RIGHT TOTAL HIP REPLACEMENT DUE TO TITANIUM ALLERGY.

  Patient problems: Foreign Body Reaction

  MAUDE report 12860358 ↗
• InjuryJun 8, 2021Fracture; Fracture

  AS REPORTED: "LEFT HIP REVISION DUE TO PERIPROSTHETIC FRACTURE. IMPLANTS WILL NOT BE RETURNED DUE TO HOSPITAL POLICY. NO MORE INFORMATION IS AVAILABLE PER DOCTOR." A STEM, HEAD, AND LINER WERE REVISED. SPOKE TO REP, WHO CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD.

  Patient problems: Insufficient Information

  MAUDE report 11957506 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: MRSA AFTER BHA. (2/4).

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 11404183 ↗
• InjuryFeb 24, 2021Degraded; Degraded

  AS REPORTED: "PERFORMED A LEFT (MAKO) HIP REVISION DUE TO CERAMIC HEAD FRACTURE AND GROSS TRUNNION FAILURE. ORIGINAL TRIDENT 2 CUP STAYED. NO MORE INFORMATION IS AVAILABLE PER DOCTOR AND IMPLANTS WILL NOT BE RETURNED DUE TO HOSPITAL POLICY." SPOKE TO REP. THE CERAMIC HEAD CRACKED IN HALF. INTRAOPERATIVELY, WEAR AND GROOVING OF THE TRUNNION OF THE STEM WAS NOTED. IT IS NOT KNOWN IF EITHER DEVICE FAILURE WAS THE CAUSE OF THE OTHER. A STEM, HEAD AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Insufficient Information

  MAUDE report 11371840 ↗
• InjuryAug 13, 2020Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  IN EMAIL CHAINS PROVIDED REPORTING A DAMAGED INSTRUMENT, THERE ARE STATEMENTS THAT THE DEVICE WAS BEING USED IN THE REVISION OF AN ACCOLADE 2 "PERMANENT" STEM. THE STATEMENT SAYS THAT THE STEM COULD NOT BE REMOVED WITH THE REPORTED DEVICE. NO APPARENT INFORMATION AT THIS TIME FOR THE REASON FOR REVISION OR HOW THE REVISION WAS CARRIED OUT. "MULTI-RECURRENT DISLOCATION THE REASON OF THE REVISION IS A CHANGE OF THE FEMORAL STEM."

  Patient problems: Injury; Joint Dislocation

  MAUDE report 10401524 ↗
• InjuryJun 24, 2020Loss of Osseointegration; Loss of Osseointegration

  DR REPORTS PATIENT POST LEFT TOTAL HIP DONE ON (B)(6) 2019 APPEARS TO HAVE A LOOSE ACCOLADE II FEMORAL STEM WHICH NEEDS TO BE REVISED. DR PROCEEDED TO REVISE THE STEM TO A SHORT CITATION HIP STEM WITH A DALL MILES CABLE. THE STEM WAS CAREFULLY REMOVED USING AN EXTRACTION HANDLE AND FLEXIBLE OSTEOTOMES. IT WAS NOTED THERE WAS NO BONY IN GROWTH OF THE STEM. SURGERY WAS PERFORMED WITHOUT INCIDENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 10189277 ↗
• InjuryJun 12, 2020Corroded; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Corroded; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS PI IS FOR LEFT HIP. 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 LEFT HIP ON OR ABOUT (B)(6) 2014. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. PATIENT HAD NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE FEMORAL HEAD AT ISSUE.

  Patient problems: Inflammation; Insufficient Information; Metal Related Pathology; Reaction

  MAUDE report 10147632 ↗
• InjuryMay 8, 2020Loss of Osseointegration; Loss of Osseointegration

  PROCEDURE: THE PATIENT UNDERWENT LEFT TOTAL HIP REPLACEMENT (B)(6) 2017. PATIENT HAD FAILED CONSERVATION MANAGEMENT OF HIP PAIN AND UNDERWENT TOTAL HIP REVISION TO TREAT THE PAIN AND DYSFUNCTION. NO INFECTION. THE FEMORAL STEM WAS GROSSLY LOOSE. LINER, HEAD AND STEM COMPONENTS WERE EXCHANGED WITH OFF-LABEL USE COMPONENTS (B)(6) 2019.

  Patient problems: Injury; Pain

  MAUDE report 10039708 ↗
• InjuryMay 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT AFTER BROACHING, A SIZE 6 ACCOLADE II STEM WAS IMPLANTED AND THE PATIENT'S FEMUR FRACTURED. THE STEM WAS PULLED AND SURGEON ATTEMPTED TO USE A COMPETITOR PLATING/ CABLING SYSTEM TO ADDRESS THE FRACTURE. THE FRACTURE WASN'T PROPERLY ADDRESSED, SO THE SURGEON USED TWO CABLES TO ADDRESS THE FRACTURE, AND IMPLANTED A SIZE 5 ACCOLADE II STEM. PRIOR TO THIS, SURGEON TRIALLED AND DECIDED ON A 50MM ACETABULAR SHELL. ON IMPLANTATION OF THE SHELL, SURGEON MADE A CLINICAL DECISION TO UPSIZE THE SHELL TO 52MM INSTEAD. SURGERY WAS COMPLETED SUCCESSFULLY WITH AN OVERALL DELAY OF APPROXIMATELY 4 HOURS. NO ADDITIONAL OR UNEXPECTED TREATMENT WAS PERFORMED, BUT THE PATIENT WAS TO ALSO HAVE A WRIST SURGERY WHICH HAD TO BE POSTPONED AS A RESULT OF THE DELAY. REP PROVIDED THE USAGE SHEET FROM THE PROCEDURE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 10017489 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  LEFT HIP REVISION FOR PAIN, PSEUDO TUMOR, AND ELEVATED COBALT LEVELS. CUP, SCREWS, INSERT, AND HEAD WERE REVISED. COMPETITOR CUP, SCREWS, AND INSERT WERE USED ALONG WITH A STRYKER UNIVERSAL TAPER CERAMIC HEAD.

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

  MAUDE report 9850314 ↗
• InjuryDec 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "TRAUMATIC (SLIP AND FALL ON ICE) PERIPROSTHETIC [FEMORAL] FRACTURE. IMPLANTED COMPETITOR STEM, BODY, AND HEAD. IMPLANTED STRYKER LINER 10° 36MM F, COMPETITOR CABLES AND 5-HOLE TROCHANTERIC PLATE. CUP AND SCREWS INTACT.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9531991 ↗
• InjuryOct 17, 2019Mechanical Problem; Mechanical Problem

  PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL HIP REPLACEMENT (B)(6) 2016. PATIENT HAD MECHANICAL FAILURE OF RIGHT HIP AND UNDERWENT REVISION SURGERY TO TREAT PAIN AND DYSFUNCTION (B)(6) 2019. ONLY THE HEAD AND STEM WERE EXCHANGED.

  Patient problems: Injury; Pain

  MAUDE report 9202285 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  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) 2016 AND WAS REVISED ON AN UNKNOWN DATE. 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: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 9164891 ↗
• InjuryJul 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "THE FEMORAL STEM WAS CHANGED FROM AN ACCOLADE II TO A CONICAL REST-MOD STEM, FOR THE SAKE OF CHANGING THE STEM'S ANTEVERSION, IN ORDER TO INCREASE HIP STABILITY FOLLOWING A HEMIPELVECTOMY. THE MDM AND [BIOLOX] FEMORAL HEAD COMPONENTS WERE CHANGED AS PART OF THIS SURGEON'S IRRIGATION AND DEBRIDEMENT PROTOCOLS. NO OTHER COMPLAINTS REPORTED". SPOKE TO REP. THERE ARE NO ALLEGATIONS AGAINST ANY STRYKER DEVICES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8811271 ↗
• InjuryApr 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A PRIMARY LEFT HIP IMPLANT. INTRA-OPERATIVELY, SURGEON REPORTED HE FELT PATIENT'S BONE QUALITY WAS POOR. PRIOR TO SURGERY COMPLETION, INTRA-OP X-RAYS WERE TAKEN WITH NO FRACTURES EVIDENT. AN X-RAY WAS LATER TAKEN WHEN THE PATIENT WAS POST ANESTHESIA AND A FEMORAL PERIPROSTHETIC FRACTURE WAS DISCOVERED. PATIENT WAS BROUGHT BACK INTO SURGERY THE SAME DAY FOR REVISION. AN ACCOLADE II STEM AND 36 +2.5 BIOLOX CERAMIC HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH ANOTHER 36 +2.5 BIOLOX CERAMIC HEAD, 8 SCREWS (CANCELLOUS, CORTICAL, PERIPROSTHETIC), AND 8 DALL-MILES CABLE AND SLEEVE SETS. REP PROVIDED IMPLANT SHEETS FROM PRIMARY AND REVISION. REP ALSO REPORTED ONLY INTRA- AND POST-OPERATIVE X-RAYS MAY BE AVAILABLE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8478515 ↗