Accolade 6721-0737Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 04546540669520), received between Mar 15, 2017 and May 28, 2026 — classified as 37 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryMay 28, 2026Material Erosion

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2016 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM WHICH WAS REVISED ON (B)(6) 2025 DUE TO ALLEGED PAIN AND SIGNS OF METALLOSIS.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 25315525 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: A FRACTURE WAS CONFIRMED AT THE DISTAL END OF THE STEM DURING THE POST-OPERATIVE X-RAY. TWO WIRES WERE USED FOR IT. THE PHYSICIAN COMMENTED THAT IT MUST HAVE CRACKED WHEN PUT IN THE TRIAL OR THE IMPLANT.

  Patient problems: Periprosthetic fracture

  MAUDE report 23788974 ↗
• InjuryFeb 19, 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 AFTER PATIENT FELL AND SUSTAINED A FEMORAL FRACTURE. THE STEM, HEAD, AND LINER WERE REVISED TO COMPETITOR FEMORAL IMPLANTS AND AN MDM METAL LINER. 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: Hip Fracture

  MAUDE report 18729750 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REV RTHA. PERI PROSTHETIC FRACTURE. EVERYTHING OUT. SHE IS PUTTING ON A CABLE AND USING COMPETITOR FOR THE REVISION. NOTHING WRONG WITH ANY OF THE STRYKER PARTS. PATIENT FELL AND FRACTURED HIS HIP." PATIENT'S FEMUR FRACTURED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 18702964 ↗
• InjuryFeb 8, 2024Material Erosion; 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 HIS RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2023. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Foreign Body Reaction

  MAUDE report 18673500 ↗
• InjurySep 14, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AS REPORTED: "PLEASE FIND ATTACHED INFORMATION FROM INDEX AND REVISION SURGERIES OF A RIGHT TOTAL HIP. THE REVISION WAS SECONDARY TO DISLOCATION. IT WAS DISCOVERED THAT THE CERAMIC HEAD DISASSOCIATED FROM THE POLY INSERT. ALSO DISCOVERED WAS A CRACK IN THE ACETABULUM AND THE APPEARANCE THAT THE CUP HAD MOVED. IT WAS ALSO DETERMINED THAT THE STEM WAS LOOSE. ALL IMPLANTS WERE REMOVED. A MULTIHOLE CUP WAS IMPLANTED WITH MULTIPLE SCREWS AND AN MDM LINER. THE FEMUR WAS PREPARED FOR AN INSIGNIA STEM AND TRIALED. THE HIP REMAINED GROSSLY UNSTABLE SO IT WAS DECIDED TO LEAVE THE PATIENT WITH A GIRDLESTONE. THE PLAN BEING TO COME BACK AFTER THE CUP HAS HEALED AND PLACE A REST MOD WITH CONSTRAINED LINER. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL."

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Joint Dislocation

  MAUDE report 17747412 ↗
• InjuryMay 17, 2023Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "HIP REVISION. REVISED STRYKER IMPLANTS: EXPLANTED ACCOLADE STEM, FEMORAL HEAD, & X3 INSERT DUE TO LOOSENING OF FEMORAL STEM."

  Patient problems: Inadequate Osseointegration

  MAUDE report 16944620 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRIDENT II STUDY. POSTOPERATIVELY, AN INFECTION WAS FOUND ON THE PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 16483850 ↗
• InjuryFeb 14, 2023Adverse 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: "CUSTOMER IS REPORTING A PRODUCT COMPLAINT FROM A REVISION CASE" .

  Patient problems: Insufficient Information; Pain

  MAUDE report 16370839 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A LEFT TOTAL HIP DUE TO PERIPROSTHETIC FRACTURE OF THE FEMUR. HE REVISED USING A COMPETITOR STEM. WHILE IN THERE, HE CHANGED THE LINER. NO ALLEGATIONS AGAINST THE IMPLANTS MADE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15555048 ↗
• InjuryJul 28, 2022Material Erosion; Material Erosion

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON (B)(6) 2013. IT IS FURTHER ALLEGED THAT HE SUFFERED PROGRESSIVE GROIN AND LEFT HIP PAIN, ELEVATED COBALT LEVEL AT 4.3 AND ON (B)(6) 2020 UNDERWENT REVISION SURGERY OF THE ACETABULAR LINER AND FEMORAL HEAD.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 15122270 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THA IN 2016 AND PRESENTED WITH PAIN. IT WAS FURTHER REPORTED THAT XRAYS SHOW SOME REMODELING ON CORTEX AND THE PATIENT REQUIRED REVISION OF THE FEMORAL STEM TO REST MOD.

  Patient problems: Pain

  MAUDE report 11776964 ↗
• InjuryApr 12, 2021Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AFTER PATIENT COMPLAINT OF THIGH PAIN, STEM LOOSENING WAS SUSPECTED, AND CONFIRMED INTRA-OPERATIVELY THAT THE STEM DID NOT FULLY INTEGRATE WITH BONE. THE STEM, HEAD AND LINER WERE REVISED TO A COMPETITOR STEM AND HEAD WITH A STRYKER LINER. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11650132 ↗
• InjuryJan 4, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SUBSIDENCE OF THE FEMORAL STEM. THE STEM AND HEAD WERE REVISED TO A NEW STEM AND HEAD. REP PROVIDED PRIMARY AND REVISION USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Information

  MAUDE report 11108801 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE: PATIENT UNDERWENT INDEX THA ON (B)(6) 2020. THEN THE PATIENT HAD A PERIPROSTHETIC FRACTURE (B2) OF THE FEMUR. ALL COMPONENTS WHERE EXCHANGED EXCEPT THE CUP ON (B)(6) 2020.

  Patient problems: Bone Fracture(s)

  MAUDE report 11045580 ↗
• InjuryDec 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REVISED A STEM /HEAD DUE TO RIGHT SIDE FEMORAL PERIPROSTHETIC FRACTURE AFTER THE PATIENT FELL. THE ORIGINAL DATE OF SURGERY (MAKO HIP) WAS (B)(6) 2020.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 10940578 ↗
• InjurySep 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REVISED A TOTAL HIP DUE TO PERIPROSTHETIC FRACTURE BY CHANGING THE STEM AND HEAD TO A CONE/CONICAL. ORIGINAL WAS DONE ON (B)(6) 2020.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10481510 ↗
• InjuryJul 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE. THE PATIENT'S ENTIRE HIP CONSTRUCT WAS REVISED, AS THE SURGEON REPORTED THAT THE SHELL WAS IN POOR POSITION. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10288217 ↗
• InjuryJul 1, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Degraded; 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 HIS RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2017. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Foreign Body Reaction; Inflammation; Injury; Metal Related Pathology; Necrosis; Reaction

  MAUDE report 10217225 ↗
• InjuryJul 1, 2020Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING REVISION OF AN ACCOLADE 2 STEM, 36MM+5 HEAD, TRIDENT CUP WHEN HEAD WAS REMOVED FROM STEM THERE WERE BLACK DEBRIS NOTICED ON STEM TRUNION AND IN THE FEMORAL HEAD.

  Patient problems: Injury; Pain; Reaction

  MAUDE report 10216703 ↗
• InjuryDec 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL. THE PATIENT'S ACCOLADE II STEM AND BIOLOX FEMORAL HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH COMPETITOR CABLES AND A NEW FEMORAL HEAD. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND PROVIDED THE PRIMARY USAGE SHEET, AND ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

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

  MAUDE report 9459228 ↗
• InjurySep 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE. AN ACCOLADE II STEM AND FEMORAL HEAD WERE REVISED TO A RESTORATION PS LONG STEM WITH A BIOLOX HEAD AND ADAPTER SLEEVE. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, PROVIDED THE REVISION USAGE SHEET, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9109346 ↗
• InjuryJun 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL. PATIENT'S STEM, HEAD AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, 22.2 +0 METAL HEAD, AND AN ADM/ MDM LINER CONSTRUCT ALONG WITH 7 CABLE AND SLEEVE SETS. REP PROVIDED AN EXPLANT PICTURE AND REVISION IMPLANT SHEET AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 8734708 ↗
• InjuryMay 20, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO STEM SUBSIDENCE AND SHELL LOOSENING. PATIENT FACTORS AS REPORTED BY REP: "RENAL FAILURE PATIENT. DIALYSIS PATIENT WITH HEPATITIS B¿NO OBVIOUS INFECTION". REP PROVIDED A PRE-REVISION X-RAY AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Hepatitis; Injury; Renal Failure

  MAUDE report 8624441 ↗
• InjuryMar 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL (CAUSE OF FALL NOT REPORTED TO REP). A HEMI HIP CONSTRUCT WITH A STEM, FEMORAL HEAD, AND BIPOLAR COMPONENT WAS REVISED TO ANOTHER STRYKER HEMI HIP CONSTRUCT PLUS CABLES.

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

  MAUDE report 8395170 ↗