Accolade 6021-4535Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 04546540510761), received between May 26, 2016 and Aug 31, 2026 — classified as 70 injuries.

The most frequently reported specific device problem is “Degraded” (28 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 70 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Loss of Osseointegration

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 50518139 ↗
• InjuryMay 6, 2026Material Erosion; Fracture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: THE HIP GIVES WAY, RESULTING IN A FALL DURING AN EVERYDAY ACTIVITY; AN X-RAY SUBSEQUENTLY REVEALS A CONICAL FRACTURE OF THE FEMORAL SHAFT.

  Patient problems: Bone Fracture(s); Fall; Periprosthetic fracture

  MAUDE report 25091282 ↗
• InjuryOct 31, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  LETTER RECEIVED FROM AN ATTORNEY ALLEGING THAT PATIENT HAD HIP EXPLANTED ON (B)(6) 2015. UNKNOWN HIP IMPLANTS WERE REVISED FOR UNKNOWN REASON AND ATTORNEY IS REQUESTING DEVICES BE RETURNED. UPDATE: THE PREOPERATIVE DIAGNOSIS WAS "RIGHT TOTAL HIP ARTHROPLASTY FAILURE FEMORAL COMPONENT" AND THE POSTOPERATIVE DIAGNOSIS WAS "DECOUPLING HEAD AND NECK WITH METALLOSIS RIGHT TOTAL HIP ARTHROPLASTY.".

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 23439871 ↗
• InjurySep 24, 2025Material Erosion; Fracture; Detachment of Device or Device Component; Material Erosion; Fracture; Detachment of Device or Device Component

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 23137221 ↗
• InjuryJul 11, 2025Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO EXCESSIVE TRUNNION WEAR. THE STEM, HEAD AND LINER WERE REVISED TO A NEW STRYKER LINER AND COMPETITOR FEMORAL IMPLANTS. REP CONFIRMED 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 22477352 ↗
• InjuryMar 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2015 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE WAS REVISED ON (B)(6) 2024 DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 21708504 ↗
• InjuryJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2013 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HIS RIGHT HIP WAS REVISED ON (B)(6) 2023 ALLEGEDLY DUE TO HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 21080571 ↗
• InjuryDec 10, 2024Corroded; Corroded

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2009 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HE WAS REVISED ON (B)(6) 2023 ALLEGEDLY DUE TO CORROSION.

  Patient problems: Insufficient Information

  MAUDE report 20896870 ↗
• InjuryOct 23, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PT. CALLED AND REPORTED THAT; THEY HAVE A RECALLED HIP AND HAVE TO HAVE IT REPLACED. IT'S OSTEONICS ACCOLADE SYSTEM AND IT WAS DONE (B)(6) 2013. INSURANCE CALLED ME AND SAID THAT HIP WAS RECALLED. I'VE REALLY SUFFERED. THE PAIN IS REALLY REALLY BAD AND CAN HARDLY WALK. PENDING REVISION. ADDITIONAL INFO: 7-NOV-2024: PT. WAS REVISED ON (B)(6) 2024.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20513360 ↗
• InjurySep 6, 2024Corroded; Degraded; Corroded; Degraded

  AS REPORTED BY CUSTOMERS SOLICITOR: ON OR AROUND (B)(6) 2008 THE CLAIMANT UNDERWENT A LEFT HIP REPLACEMENT WITH A FOLLOW UP OPERATION ON OR AROUND THE (B)(6) 2009. IT IS SUBMITTED THAT THE IMPLANTS SUPPLIED WERE DEFECTIVE AND DUE TO THE SAME THE CLAIMANT'S HIP BECAME INFECTED SUBJECTING THE CLAIMANT TO WORSENING HIP PAIN FROM (B)(6) 2023 ONWARDS. FOLLOWING INVESTIGATIONS, IT WAS DISCOVERED THAT CORROSION OF THE IMPLANTS WAS THE CAUSE OF THE ONGOING INFECTION/SYMPTOMS NECESSITATING THE REMOVAL AND REPLACEMENT OF THE DEFECTIVE IMPLANTS. THIS REVISION SURGERY TOOK PLACE IN (B)(6) 2023. UPDATE AS PER MEDICAL REVIEW: A LOOSE ACETABULAR COMPONENT WAS ALSO NOTED.

  Patient problems: Bacterial Infection; Pain; Unspecified Infection

  MAUDE report 20155379 ↗
• InjuryAug 21, 2024Material Erosion; Material Erosion

  IT WAS REPORTED BY PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT WAS IMPLANTED WITH AN ACCOLADE TMZF HIP STEM AND LFIT ANATOMIC V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2009. IT IS ALLEGED THAT THE PATIENT HAS BEEN EXPERIENCING SEVERE PAIN IN HIS LEFT HIP AND IS CURRENTLY BEING EVALUATED AND IT APPEARS HE WILL BE REQUIRED TO UNDERGO REVISION SURGERY ON HIS LEFT HIP IN THE NEAR FUTURE. UPDATE PER MEDICAL RECORDS RECEIVED: THE PATIENT'S LEFT HIP WAS REVISED ON (B)(B) 2024 DUE TO GROSS TRUNNION FAILURE AND METALLOSIS WHEREBY THE STEAM, HEAD, AND LINER WERE REVISED AND A RESTORATION MODULAR STEM CONSTRUCT WAS IMPLANTED.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 20017338 ↗
• InjuryJul 22, 2024Degraded; Detachment of Device or Device Component; Degraded; 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) 2007 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE STEM REQUIRING REVISION SURGERY ON (B)(6) 2024, DUE TO ALLEGED BROKEN TRUNNION. THE SURGEON ¿ENCOUNTERED DARK JOINT FLUID AND HEAVILY PIGMENTED TISSUE CONSISTENT WITH METALLOSIS.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology

  MAUDE report 19802725 ↗
• InjuryMay 31, 2024Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component

  SURGEON CALLED ME AFTER A REVISION OF AN ACCOLADE TMZF STEM. THE SURGEON SAID THAT STEM/HEAD HAS ALMOST AN IDENTICAL ISSUE AS ANOTHER REVISION HE DID IN FEBRUARY. HE SAID THAT THE STEM TRUNNION IS WORN AND DAMAGED AND SO IS THE HEAD. THERE IS POLY BACKSIDE WEAR, WHERE IT LOOKS LIKE A THIN FILM OF PLASTIC HAS DELAMINATED FROM THE BACK OF THE LINER. HE SAID THE LINER IS WORN BUT NOT FAILED. HE SAID THE PATIENT HAS HAD 4-5MONTHS OF PAIN IN THE HIP, UNKNOWN ORIGIN, THEY TWISTED IN THE KITCHEN THE WEEK BEFORE, AND SUDDENLY COULDN'T WEIGHT BEAR ANYMORE. THERE WAS LOTS OF METALLOSIS IN THE PATIENT. I WILL ADD MORE NOTES TO THIS AFTER GETTING MORE DETAILS FROM THE SURGEON IN THE COMING DAYS. POSTERIOR APPROACH, LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 19434134 ↗
• InjuryApr 3, 2024Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE "PATIENT ARRIVED IN CLINIC WITH OBVIOUS COMPONENT FAILURE ON X-RAY. FELT HIP LET GO. X-RAYS FROM (B)(6) 2023 SHOWED EVIDENCE OF START OF FAILURE. THE X-RAY SHOWING FULL FAILURE WAS TAKEN ON (B)(6) 2024."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19037611 ↗
• InjuryJan 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY PATIENT'S COUNSEL THAT ALLEGEDLY ON (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD ON HIS LEFT HIP. IT IS FURTHER ALLEGED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 DUE TO HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 18462723 ↗
• InjuryNov 2, 2023Degraded; Degraded

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2012, AND WAS IMPLANTED WITH A ACCOLADE TMZF HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD. HE WAS REVISED ON (B)(6) 2021, ALLEGEDLY DUE TO PAIN, ELEVATED COBALT LEVELS AND TRUNNIONOSIS.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18054151 ↗
• InjuryOct 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT ARRIVED IN ER WITH DISCOMFORT IN HIP. COMPONENT FAILURE DISCOVERED UPON XRAY. THE HEAD DISASSOCIATED FROM THE STEM.

  Patient problems: Discomfort; Pain

  MAUDE report 17854890 ↗
• InjurySep 18, 2023Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED BY PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT WAS IMPLANTED WITH AN ACCOLADE TMZF HIP STEM AND LFIT ANATOMIC V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2009. IT IS ALLEGED THAT HE DEVELOPED SEVERE PAIN IN THE RIGHT HIP AND THE INABILITY TO WALK OR BEAR WEIGHT ON THE RIGHT LEG, TRUNNIONOSIS, ALMOST COMPLETE DISASSOCIATION BETWEEN THE FEMORAL HEAD AND NECK, AND A METALLOSIS. HE WAS REVISED ON (B)(6) 2022.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 17763939 ↗
• InjurySep 6, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED BY PATIENT'S ATTORNEY THAT ALLEGEDLY HE WAS IMPLANTED WITH AN ACCOLADE TMZF HIP STEM AND LFIT COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON (B)(6) 2011, AND WAS REVISED ON (B)(6) 2022. IT IS FURTHER ALLEGED THAT X-RAY TAKEN IN THE ER SHOWED A DISASSOCIATION BETWEEN THE FEMORAL HEAD AND THE FEMORAL STEM.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 17691780 ↗
• InjuryApr 26, 2023Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  IT WAS REPORTED REVISION SURGERY WAS REQUIRED AS IT WAS IDENTIFIED THROUGH X RAYS THAT THE HEAD HAD DISASSOCIATED FROM THE TRUNNION. IT WAS FURTHER REPORTED THAT THE ORIGINAL IMPLANT SURGERY WAS APPROXIMATELY 10 YEARS PRIOR.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology

  MAUDE report 16820532 ↗
• InjuryDec 5, 2022Degraded; Unstable; Degraded; Unstable

  PATIENT WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD ON HER LEFT HIP ON (B)(6) 2010. IT IS FURTHER ALLEGED THAT SHE NOTED INCREASING PAIN AND FEELING OF INSTABILITY IN HER HIP. X-RAYS OBTAINED IN OCTOBER ALLEGEDLY SHOWED TRUNNION DAMAGE AND THE HEAD ON AN ANGLE. DURING REVISION SURGERY ON (B)(6) 2019, "THE BALL WAS GROSSLY LOOSE ON THE TRUNNION AND"..."THE TIP OF THE TRUNNION HAD BEEN WHITTLED DOWN TO A SHARP POINT." "THERE WAS GROSS DAMAGE FROM THE SHARP TRUNNION TIP RIDING INTO THE POLYETHYLENE."

  Patient problems: Joint Laxity; Pain

  MAUDE report 15913162 ↗
• InjuryNov 16, 2022Degraded; Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unintended Movement; Degraded; Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO TRUNNION WEAR AND HEAD DISSOCIATION. INTRA-OPERATIVELY, IT WAS DISCOVERED THE TRUNNION DUG THROUGH THE LINER AND WAS ARTICULATING AGAINST THE SHELL, CAUSING ADDITIONAL WEAR. METALLOSIS WAS ALSO NOTED. THE STEM, HEAD, AND LINER WERE REVISED. REP CAN PROVIDE PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 15803531 ↗
• InjuryOct 19, 2022Degraded; Detachment of Device or Device Component; Insufficient Device Problem Information; Degraded; Detachment of Device or Device Component; Insufficient Device Problem Information

  DISTRIBUTOR REPORTED THAT "PATIENT REQUIRED A TOTAL REVISION OF RIGHT HIP."

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15630876 ↗
• InjuryOct 16, 2022Material Erosion; Fracture; Material Erosion; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNION WEAR AND METALLOSIS. INTRA-OPERATIVELY, LINER WEAR WAS ALSO NOTED. THE STEM, HEAD, AND LINER WERE REVISED.

  Patient problems: Metal Related Pathology

  MAUDE report 15612897 ↗
• InjuryAug 8, 2022Fracture; Unstable; Detachment of Device or Device Component; Fracture; Unstable; Detachment of Device or Device Component

  AS REPORTED: "REVISION FOR PAIN AND INSTABILITY OF RIGHT TOTAL HIP. PATIENT REPORTED INDEX TOTAL HIP OVER 10 YEARS AGO. X-RAY DEMONSTRATES PARTIAL DISSOCIATION FROM FEMORAL STEM. OPERATIVE FINDINGS INCLUDED METALLOSIS WITH ASSOCIATED SOFT TISSUE STAINING. DAMAGED TRUNNION OF THE FEMORAL STEM WAS NOTED. THE STEM WAS WELL FIXED. IT WAS EXPLANTED USING HIGH SPEED BUR AND USE OF FLEXIBLE OSTEOTOMES. FEMUR WAS PREPARED AND IMPLANTED WITH A REVISION FEMORAL PROSTHESIS FROM ANOTHER MANUFACTURER."

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 15188293 ↗