Accolade 6720-0737Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04546540664501), received between Jun 12, 2017 and Sep 25, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Patient Device Interaction Problem

  The following information was provided: Incoming letter from the user: Can you provide a document containing the necessary information about the composition (in terms of metals) of the endoprosthesis? I am currently dealing with a systemic immune reaction to the prosthesis (which was implanted in (b)(6)). I am scheduled for a revision (replacement), so it is absolutely essential to determine which metal I am allergic to in order to select a prosthesis made of alloys that are suitable specifically for me. I would very much like to minimize the risk of becoming disabled.

  Patient problems: Foreign Body Reaction

  MAUDE report 50896026 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  REP WAS CONTACTED WITH A REQUEST TO SEE IF A 40 +0 LFIT V40 HEAD WAS RECALLED. LEFT HIP. REVISION (IN THE COMING MONTHS) DUE TO METALLOSIS.

  Patient problems: Foreign Body Reaction

  MAUDE report 24648080 ↗
• InjuryFeb 22, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED A REVISION OF RIGHT HIP WHERE ALL PARTS WERE REMOVED AND NEW IMPLANTS IMPLANTED ON (B)(6), 2023 DUE TO PAIN AND A "THUMPING" SOUND IN HIS RIGHT HIP. PATIENT REPORTED PREVIOUS HEALTH ISSUES, SUCH AS BACK PAIN AND FEMORAL ARTERY BYPASS.

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

  MAUDE report 18764099 ↗
• InjuryOct 4, 2022Corroded; Material Erosion; Corroded; 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 LEFT HIP ON OR ABOUT (B)(6), 2015 AND WAS REVISED ON (B)(6), 2022. 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: Bone Fracture(s); Fall; Metal Related Pathology; Swelling/ Edema

  MAUDE report 15534772 ↗
• InjuryJun 20, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO FEMORAL FRACTURE AND STEM SUBSIDENCE (POSSIBLE CAUSE OR CONTRIBUTOR OF BONE FRACTURE NOT REPORTED TO THE REP). A STEM AND HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A FEMORAL HEAD, AND CABLES. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 14749325 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BIPOLAR CUP DISLOCATED FROM INNER HEAD. HE HAD TWO REDUCTION WITHIN TWO WEEKS. UPDATE (B)(6) 2022: STEM WAS REVISED FOR AN UNKNOWN REASON.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 14237571 ↗
• InjuryJan 4, 2022Unintended Movement; Unintended Movement

  AS REPORTED: "PATIENT PRESENTED TO DR. WITH PAIN POST-OPERATIVELY. DR. ASSESSED THAT THE STEM HAS SUBSIDED 5 MM INTO THE FEMUR." AN ACCOLADE 2 STEM AND BIOLOX DELTA V40 HEAD WERE REVISED. IT IS UNKNOWN AT THIS POINT IF THERE ARE ALLEGATIONS AGAINST THE REVISED HEAD. UPDATE: NO ALLEGATIONS AGAINST THE REVISED HEAD. RIGHT HIP.

  Patient problems: Pain

  MAUDE report 13150634 ↗
• InjuryAug 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. SPOKE TO THE BRANCH OPERATIONS MANAGER, WHO SAID THAT THE REP HAD REPORTED THAT THE PATIENT WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL. REP HAD ALSO REPORTED THERE WERE NO ALLEGATIONS AGAINST THE STRYKER IMPLANTS. AN ACCOLADE II STEM AND BIOLOX HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH ANOTHER CERAMIC HEAD, AND 2 CABLE AND SLEEVE SETS. UPDATE 06/AUGUST/2021 WG: ADDITIONAL INFORMATION PROVIDE BY THE REP: "REPORTED TO HOSPITAL FOR REVISION SURGERY. I WAS TOLD THAT THE PATIENT FELL THE DAY BEFORE AT GROCERY STORE. BONE BROKE AROUND STEM THAT WAS PLACED ON (B)(6) 2021 CAUSING IT TO BE LOOSE. WE REMOVED THE STEM AND FEMORAL. CERCLAGED THE BONE AND PLACED A REVISION STEM AND NEW FEMORAL HEAD. NO NEGATIVE PRODUCT EXPERIENCE REPORTED BY SURGEON. NO IMPLANTS, NO XRAYS, NO INFORMATION RETURNED PER POLICY OF HOSPITAL."

  Patient problems: Bone Fracture(s)

  MAUDE report 12365045 ↗
• InjurySep 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED FOR A PERIPROSTHETIC FRACTURE OF THE FEMUR. THE FEMORAL HEAD WAS REVISED TO A NEW HEAD AND SLEEVE WITH 3 SETS OF CABLES. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10483500 ↗
• InjuryNov 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REVISED A LEFT HIP ORIGINALLY DONE (B)(6) 2013 DUE TO CUP LOOSENING. HE NOTED THE COBALT LEVELS WERE AT 7.7. DURING THE REVISION, HE OBSERVED BLACK RESIDUE INSIDE THE FEMORAL HEAD WHEN REMOVED. HE NOTED THE SHORT ROTATORS AND POSTERIOR CAPSULAR LIGAMENT AND ABDUCTORS WERE "DEAD." HE OBSERVED THAT THE STEM TRUNION WAS OKAY AND DECIDED TO LEAVE THE STEM IN PLACE. THE CUP WAS COMPLETELY LOOSE. HE REVISED TO A MULTI-HOLE SIZE 62 AND MDM. UPDATE (B)(6) 2019 WG: REP PROVIDED EXPLANT PICTURES, X-RAYS, USAGE SHEETS FROM PRIMARY AND REVISION SURGERY, AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9274454 ↗
• InjuryOct 17, 2019Osseointegration Problem; Osseointegration Problem

  PROCEDURE: THE PATIENT UNDERWENT LEFT TOTAL HIP REPLACEMENT (B)(6) 2018. PATIENT UNDERWENT LEFT TOTAL HIP REVISION WITH MECHANICAL COMPLICATIONS. THERE WAS A LOOSENING IN THE FEMORAL STEM WHICH WAS REPLACED ALONG WITH A NEW NECK OFFSET AND CERAMIC HEAD (B)(6) 2019.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9202283 ↗
• InjuryOct 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT FELL AND HAS RIGHT FEMORAL PERIPROSTHETIC FRACTURE. TAKING OUT TOTAL HIP COMPONENTS AND DOING A REVISION REST MOD HIP WITH MDM.

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

  MAUDE report 9174531 ↗
• MalfunctionOct 7, 2019Packaging Problem; Packaging Problem

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM THE OUTER BOX, THE INNER STERILE BLISTER WAS OBSERVED TO BE SITTING PROUD IN THE OUTER STERILE BLISTER. THE EDGE OF THE INNER BLISTER WAS HIGHER ON ONE SIDE THAN THE EDGE OF THE OUTER BLISTER, AND THE TYVEK FOR THE INNER BLISTER WAS PROTRUDING OUT FROM UNDER THE OUTER STERILE BLISTER. DUE TO STERILITY CONCERNS, THE DEVICE WAS NOT OPENED ANY FURTHER AND DID NOT ENTER THE STERILE FIELD AS IT WAS RETURNED TO THE BACK TABLE. AT THE TIME OF OPENING, THE OUTER BOX APPEARED TO BE FULLY INTACT WITH NO DAMAGE. REP PERSONALLY WITNESSED THE EVENT. THE IMPLANT STICKER WAS NOT APPLIED TO THE USAGE SHEET. ANOTHER DEVICE WAS OBTAINED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 4 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9162685 ↗
• InjuryAug 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED BY REP: "THE PATIENT PRESENTED THIS WEEK WITH A PERIPROSTHETIC FRACTURE, SUSPECTED TO HAVE SUFFERED A FALL. NO FURTHER PATIENT INFORMATION, DOCUMENTATION, OR IMAGING AVAILABLE". THE PATIENT'S ENTIRE HEMI HIP WAS REVISED TO A HEMI HIP. UPDATE: "PLEASE CONFIRM THE LOCATION OF THE BONE FRACTURE: PROXIMAL FEMUR. WERE THERE ANY ALLEGATIONS AGAINST THE REVISED HEAD? NO. IS THE HOSPITAL RETAINING THE EXPLANTS? YES. THERE ARE 2 FEMORAL HEADS LISTED 26 +4 AND 26 +0 WITH NO INDICATION AS TO WHETHER ONE WAS WASTED. A 26 +4 WAS IMPLANTED FOR THE REVISION. CAN YOU PLEASE CONFIRM WHICH HEAD WAS NOT USED, AND WHY IT WASN¿T USED? I WAS NOT PRESENT FOR THE ORIGINAL SURGERY WHEREIN A HEAD WAS WASTED. GENERALLY, A CHANGE IN HOW HIGH/LOW THE STEM SITS WITHIN THE FEMUR COMPARED TO THE BROACH DURING TRIALING WOULD NECESSITATE A CHANGE IN HEAD/NECK LENGTH. HOWEVER, BASED ON THE AVAILABLE DOCUMENTATION IT WOULD SEEM THAT THE 26+0 HAD BEEN WASTED. NO COMPLAINTS OR ALLEGATIONS WERE MADE AGAINST THE IMPLANTS."

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

  MAUDE report 8939448 ↗
• InjuryJan 25, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "RIGHT HIP [REVISION], POSSIBLE LOOSE IMPLANTS, HIP PAIN". A 56 TRIDENT SHELL, 36MM X3 POLY, 36 +2.5 BIOLOX HEAD, AND ACCOLADE II #7 STEM WERE REVISED TO COMPETITOR DEVICES.

  Patient problems: Injury; Pain

  MAUDE report 8277396 ↗
• InjuryOct 16, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT UNDERWENT LEFT TOTAL HIP REPLACEMENT (B)(6) 2016. PATIENT WAS NOTED TO HAVE A FAILED LEFT HIP ARTHROPLASTY SECONDARY TO PAINFUL FEMORAL COMPONENT AND SPOT WELDING WITH LOOSENING. PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY REVISION WITH BOTH COMPONENTS (B)(6) 2018.

  Patient problems: Injury; Pain

  MAUDE report 7969574 ↗
• InjuryJul 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY CLAIMANTS ATTORNEY THAT MEREDITH WAS IMPLANTED WITH A TRIDENT HIP PSL HA CLUSTER AND LINER ON OR ABOUT (B)(6) 2015, WHICH FAILED, RESULTING IN A REPLACEMENT SURGERY ON OR ABOUT (B)(6) 2015. UPDATE AS PER MEDICAL REVIEW RECEIVED STATED " AN OFFICE VISIT NOTE FOR (B)(6) 2015 STATES, "COMPLAINING OF LEFT GROIN PAIN. X-RAY: LINER OF THE ACETABULUM ... DISASSOCIATED." THE PLAN WAS REVISION. ON (B)(6) 2015 A REVISION OF THE LEFT TOTAL HIP ARTHROPLASTY, ALL COMPONENTS, WAS PERFORMED FOR A DIAGNOSIS OF DISLOCATED ACETABULAR SHELL. THE STEM IS SUBSIDED APPROXIMATELY 1-CENTIMETER AND THE HEAD IS NOT DEEPLY SEATED IN THE ACETABULUM, WHICH MAY REPRESENT A SUBLUXATED INSERT, HOWEVER POOR RESOLUTION OF THE X-RAY IS NOTED ON THIS AND MULTIPLE INTRAOPERATIVE X-RAYS. X-RAYS DATED (B)(6) 2015 ARE MULTIPLE VIEWS OF THE LEFT HIP DEMONSTRATING THE UNCEMENTED TOTAL HIP WITH THE LINER DISASSOCIATED AND THE STEM ONCE AGAIN NOTED TO BE 1-CENTIMETER SUBSIDED."

  Patient problems: Injury; Joint Dislocation; Pain

  MAUDE report 7663744 ↗
• InjuryApr 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS THE ACCOLADE II STEM WAS INSERTED AFTER PREPARING THE FEMUR, A FEMORAL FRACTURE OCCURRED IN THE CANAL THAT FORCED US TO REPAIR IT USING CABLES, AND A LONGER (DEPUY) STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 7392353 ↗
• InjuryJun 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED, PATIENT HAD UNDERWENT SURGERY TO CORRECT BILATERAL FEMORAL NECK FRACTURES (B)(6) 2016. SHE CAME BACK INTO THE OR (B)(6) 2017 FOR A RIGHT TOTAL HIP CONVERSION. TWO DAYS LATER, SHE HEARD A POP DURING PHYSICAL THERAPY AND WAS TAKEN BACK TO THE OR FOR TREATMENT FOR A PERIPROSTHETIC FEMUR FRACTURE WITH SUBSIDENCE OF THE FEMORAL COMPONENT. FEMORAL COMPONENT AND CERAMIC HEAD WERE REPLACED.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6633153 ↗