Accolade 6720-0435Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 04546540664471), received between Jan 4, 2017 and Nov 4, 2025 — classified as 36 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Mechanical Problem; Mechanical Problem

  THIS PI IS FOR THE REVISION 2 DAYS POST IMPLANTATION. WE HAD A MAKO RTHA 4.1CASE IN WHICH WE FOLLOWED THE ROBOTIC PLAN TO MATCH THE OTHER SIDE. AFTER THE SURGERY, DOCTOR REPORTED ONE LEG BEING 1.5 CM LONGER THAN THE OTHER. PATIENT WAS EXTREMELY UNHAPPY AND WE HAD TO PROCEED WITH A REVISION. PATIENT HAD LOTS OF SOFT TISSUE ISSUES AND PELVIC ROTATION THAT I THINK WAS THE CONTRIBUTING FACTOR TO THIS DISCREPANCY. HOWEVER, THE COMPLIANCE DEPARTMENT AT THE HOSPITAL WANTS AN OFFICIAL INVESTIGATION DONE INTO THIS CASE TO MAKE SURE THIS WAS NOT A ROBOTIC ERROR (ASSOCIATED PI). DOCTOR HAS CHANGED HIS WORKFLOW TO ASSESS LEG LENGTHS PRIOR TO SURGERY AND ADJUST OUR ROBOTIC PLAN ACCORDINGLY MOVING FORWARD. I NEED THIS COMPLAINT EXPEDITED AS THE COMPLIANCE DEPARTMENT OF THE HOSPITAL IS WAITING FOR THE RESULTS OF THIS.

  Patient problems: Unequal Limb Length

  MAUDE report 23463157 ↗
• InjuryOct 20, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 23334573 ↗
• InjuryOct 15, 2025Degraded; Degraded

  NO NEW INFORMATION.

  Patient problems: Cyst(s); Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 23300244 ↗
• InjuryJun 17, 2025Adverse 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 FEMORAL PERIPROSTHETIC FRACTURE. THE STEM, HEAD AND LINER WERE REVISED. THERE WERE 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 22229520 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A GIRDLESTONE PROCEDURE WAS PERFORMED ON THE PATIENT'S LEFT HIP DUE TO MIGRATION OF A COMPETITOR SHELL. ALL COMPONENTS INCLUDING A STRYKER STEM AND HEAD WERE REMOVED. THERE WERE NO ALLEGATIONS AGAINST THE REVISED STEM OR HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 21112032 ↗
• InjuryDec 10, 2024Material Erosion; Material Erosion

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2013 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM. SHE WAS REVISED ON (B)(6)2022 ALLEGEDLY DUE TO INCREASING PAIN, STIFFNESS, OSTEOLYSIS AROUND THE IMPLANT WITH DESTRUCTIVE BONY EROSION, AND ELEVATED COBALT AND CHROMIUM LEVELS.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 20896240 ↗
• InjuryMar 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LEFT TOTAL HIP. THE REVISION TODAY WAS SECONDARY TO A FALL IN WHICH THE CERAMIC HEAD WAS DISASSOCIATED FROM THE POLY MDM INSERT. THIS DISASSOCIATION WAS DISCOVERED PREOP ON CT. IN SURGERY IT WAS FOUND THAT THE STEM WAS IMPINGING ON THE CUP POSTERIOR SUPERIOR AND HAD CAUSED A SMALL NOTCH ON THE NECK OF THE FEMORAL IMPLANT. THE 28MM HEAD AND INSERT WERE REMOVED. A +0 HEAD SEAMED TO ELIMINATE THE IMPINGEMENT PROBLEM AND STABILIZE THE JOINT. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Fall

  MAUDE report 18957860 ↗
• InjuryNov 21, 2023Adverse 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 PAIN. A STEM, HEAD AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH ANOTHER HEAD AND LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 18181416 ↗
• InjuryAug 15, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "PT PRESENTED WITH COMPLAINTS OF HIP PAIN AND FEELINGS OF INSTABILITY". IMAGING DETERMINED THE PT'S LEFT HIP STEM HAD SUBSIDED AND MAY HAVE BEEN LOOSE AS A RESULT. DR OPTED TO REVISE THE STEM TO AN RMOD CONSTRUCT. NO FURTHER INFO AVAILABLE.

  Patient problems: Pain

  MAUDE report 17553689 ↗
• InjuryAug 29, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  RIGHT HIP REVISION FOR INSTABILITY. STEM, INSERT, AND HEAD WERE REVISED. PER RESPONSE: REMOVAL OF STEM WAS NOT PLANNED DURING REVISION IT WAS REMOVED HOWEVER AS A RESULT OF INTRA-OP EVENT, "WHEN THE CONSTRAINED INSERTS FAILED, STEM REMOVAL WAS NECESSARY".

  Patient problems: Joint Laxity

  MAUDE report 15317039 ↗
• InjuryAug 22, 2022Material Erosion; Device Appears to Trigger Rejection; Material Erosion; Device Appears to Trigger Rejection

  IT WAS REPORTED: "A CASE OF METALLOSIS ON A PATIENT WHOSE HIP PROSTHESIS WAS IMPLANTED. NICKEL ALLERGY."

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 15266933 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY STRYKER SALES REP THAT PRIMARY OPERATION WAS DONE ON (B)(6) 2022. PATIENT WAS DISCHARGED AND COME BACK FOR PHYSIO. PATIENT COMPLAINED OF PAIN AFTER AND FOUND FEMUR MID-SHAFT FRACTURE. THE REVISION SURGERY IS SCHEDULED.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 14460630 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE BHA PERFORMED IN DECEMBER, INFECTION HAPPENED. 4 CASES OCCUR IN A ROW ONLY WITH OPERATIONS USING OUR PRODUCTS. LOT INVESTIGATION WAS REQUESTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11401641 ↗
• InjuryOct 21, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT: "THE PATIENT COMPLAINED ABOUT HER HIP PAIN. AFTER AN X-RAY, IT WAS DETERMINED THAT THE STEM WAS LOOSE. UPON EXPLANTATION, IT WAS DISCOVERED THAT THE STEM DID NOT FULLY HEAL, THUS CAUSING THE PATIENT PAIN."

  Patient problems: Pain

  MAUDE report 10709947 ↗
• InjurySep 22, 2020Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  THE SURGEON STATED THAT TRITANIUM LOOSENED. THE PATIENT WAS A 53-YEAR-OLD FEMALE PATIENT (160 CM IN HEIGHT AND 53 KG IN WEIGHT). UPDATE: "THE STEM WAS NOT LOOSE, BUT SINCE THE CUP OPERATION BECOMES DIFFICULT, THE SURGEON ALSO PULLS OUT THE STEM IN CASE OF CUP REPLACEMENT EVEN IF IT IS NOT LOOSE." RIGHT SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10566556 ↗
• InjuryJun 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE. A HEMI HIP WITH AN ACCOLADE II STEM, LFIT V40 HEAD, AND UHR BIPOLAR COMPONENT WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CABLES, AND NEW FEMORAL HEAD WITH BIPOLAR COMPONENT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD AND BIPOLAR COMPONENT, PROVIDED THE PRIMARY USAGE SHEET, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10189169 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL HIP REPLACEMENT (B)(6) 2019. PATIENT HAD A FALL AND SUSTAINED A FEMUR FRACTURE. THE PATIENT UNDERWENT HIP REVISION SURGERY TOTAL HIP REPLACEMENT (B)(6) 2019. FEMUR AND HEAD EXCHANGED.

  Patient problems: Bone Fracture(s); Fall; Injury

  MAUDE report 9659564 ↗
• InjuryDec 26, 2019Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN. IT WAS FURTHER REPORTED THAT AN X RAY SHOWED THE STEM WAS LOOSE.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9519560 ↗
• InjuryJun 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT¿S ALLEGED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT A LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2013 WHERE SHE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. IT IS FURTHER ALLEGED THAT BLOOD WORK REVEALED ELEVATED LEVELS OF COBALT AND CHROMIUM. PLAINTIFF HAS NOT YET BEEN REVISED.

  Patient problems: Inflammation; Reaction

  MAUDE report 8666188 ↗
• InjuryMay 13, 2019Osseointegration Problem; Osseointegration Problem

  PATIENT'S RIGHT HIP WAS REVISED. REP REPORTED THE PATIENT COMPLAINED OF THIGH PAIN AND SUSPECTED ASEPTIC LOOSENING. SURGEON REVISED TO A CEMENTED STEM. NO ALLEGATIONS AGAINST THE HEAD. REP REPORTED THAT NO FURTHER INFORMATION WILL BE PROVIDED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8603104 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE BHA WAS DONE WITH CENTRAX BIPOLAR CUP, V40 HEAD AND ACCOLADE 2 STEM AT (B)(6) 2018 FOR FEMORAL NECK FRACTURE. AT (B)(6) 2018, INFECTION WAS OCCURRED AND THE SURGEON CLEANED THE SURGICAL FIELD, EXCHANGED THE HEAD AND CUP. THE STEM WAS NOT CHANGED. AT (B)(6) 2019, THE PATIENT WAS RECOVERED. INFECTION WAS CONFIRMED CLINICALLY, MICROORGANISM UNKNOWN. PRE-EXISTING CONDITIONS: "STOMACH CANCER". RIGHT SIDE.

  Patient problems: Bone Fracture(s); Cancer; Injury; Unspecified Infection

  MAUDE report 8574791 ↗
• InjuryMar 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO A PROXIMAL FEMUR PERIPROSTHETIC FRACTURE. PATIENT'S STEM, HEAD AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH FEMORAL HEAD, MDM/ ADM LINER CONSTRUCT, AND 3 SETS OF CABLES.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8449155 ↗
• InjuryFeb 13, 2019Fracture; Fracture

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. A NOTE FROM THE REP AT THE BOTTOM INDICATES "PATIENT FELL AND HAD PERIPROSTHETIC FRACTURE. PULLED ACCOLADE 2 AND BIPOLAR SHELL, HEAD. NO FILMS/ PARTS AVAILABLE". PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH AN LFIT V40 HEAD, 45X26 UHR BIPOLAR COMPONENT, AND FOUR DALL-MILES CABLE AND SLEEVE SETS. SPOKE TO REP. PATIENT SUFFERED A FEMORAL PERIPROSTHETIC FRACTURE. X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Hip Fracture

  MAUDE report 8335627 ↗
• InjuryJan 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE ATTORNEY THAT PLAINTIFF UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015 AND HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2017 DUE TO ALLEGED ALTR.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8270325 ↗
• InjuryNov 16, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO THE ACCOLADE STEM "POTTING DISTALLY" (CONFIRMED TO MEAN THAT THE STEM WAS TOO BIG DISTALLY FOR THE PATIENT'S ANATOMY. IT NEVER FULLY SEATED). A SIZE 4 ACCOLADE II 132° STEM AND 36 +2.5 BIOLOX HEAD WERE REVISED.

  Patient problems: Injury

  MAUDE report 8077779 ↗