Accolade 6720-0837Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04546540664518), received between Feb 7, 2017 and Nov 17, 2023 — classified as 12 injuries, 2 malfunctions.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 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 FEMORAL PERIPROSTHETIC FRACTURE (NO CAUSE OR CONTRIBUTOR WAS REPORTED TO THE SURGEON OR REP). A STEM AND HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT AND A NEW HEAD. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 18157992 ↗
• InjuryAug 5, 2022Adverse 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 CONVERTED FROM A HEMI TO A TOTAL HIP DUE TO A FEMORAL PERIPROSTHETIC FRACTURE. SURGEON'S ORIGINAL PLAN WAS TO ADDRESS THE FRACTURE WITH CABLES AND PLATES, BUT INTRA-OPERATIVELY THE STEM WAS FOUND TO BE GROSSLY LOOSE. A TOTAL HIP WITH A RESTORATION MODULAR STEM CONSTRUCT, HEAD, MDM/ ADM LINER CONSTRUCT, AND SHELL WERE IMPLANTED. REP PROVIDED PRIMARY USAGE AND CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD OR BIPOLAR COMPONENT. REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 15173839 ↗
• InjuryMay 9, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED FRACTURED LEFT FEMUR SHORTLY AFTER SURGERY. UPDATE (B)(6) 2022 WG: PER STRYKER REP, PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH DALL MILES CABLES.

  Patient problems: Bone Fracture(s)

  MAUDE report 14338488 ↗
• InjuryNov 16, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SUBSIDENCE OF THE FEMORAL STEM. THE STEM AND HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD.

  Patient problems: Insufficient Information

  MAUDE report 12819808 ↗
• InjuryMar 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(6) 2019, FEMUR BROKE. SURGEON SAYS THAT DEVICE DID NOT CONTRIBUTE TO THIS EVENT. CONSERVATIVE THERAPY AND FOLLOW-UP WAS DONE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11472428 ↗
• InjuryAug 27, 2020Unstable; Unstable

  PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2020. PATIENT UNDERWENT REVISION RIGHT TOTAL HIP FOR INSTABILITY ON (B)(6) 2020. HEAD, LINER AND STEM EXCHANGED.

  Patient problems: Injury; Joint Laxity

  MAUDE report 10458126 ↗
• InjuryNov 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AN MDM INSERT AND 28 BIOLOX HEAD WERE PUT TOGETHER ON THE BACK TABLE USING THE MDM INSTRUMENTATION. AFTER ASSEMBLY THE HEAD WAS CHECKED TO MAKE SURE THE 28 INNER HEAD MOVED FREELY INSIDE THE INSERT. THE SURGEON PROCEEDED TO IMPLANT WITH THE CORRECT HEAD PUSHER FROM THE SET AND THE INSERT AND HEAD DISASSOCIATED DURING HIP REDUCTION. UPDATE 31/OCTOBER/2019 WG: SPOKE TO REP. THE FOLLOWING SEQUENCE OF EVENT OCCURRED DURING A PRIMARY RIGHT HIP PROCEDURE: A FEMORAL HEAD DISASSOCIATED FROM AN ADM/ MDM INSERT DURING REDUCTION. A SECOND FEMORAL HEAD AND ADM/ MDM INSERT WERE ASSEMBLED. PATIENT FACTORS (REPORTED BY THE SURGEON AS A COMBINATION OF THE PATIENT'S WEIGHT AND SPINAL PROBLEMS. THESE FACTORS APPLY TO THE NEXT TWO PAIRS OF HEADS AND LINERS) PROHIBITED THE HIP FROM BEING REDUCED, AND THE PATIENT'S FEMUR FRACTURED. THE ACCOLADE II STEM WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH DALL- MILES CABLE SETS. A THIRD PAIR OF FEMORAL HEAD AND ADM/MDM INSERT WERE ASSEMBLED AT THE BACK TABLE, AFOREMENTIONED PATIENT FACTORS PROHIBITED THE HIP FROM BEING REDUCED. A FOURTH PAIR OF ADM/ MDM INSERT AND FEMORAL HEAD WERE ASSEMBLED AT THE BACK TABLE, AFOREMENTIONED PATIENT FACTORS PROHIBIT

  Patient problems: Bone Fracture(s); Injury; Joint Dislocation

  MAUDE report 9385726 ↗
• InjuryMar 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT STATED HE WAS EXPERIENCING A LOT OF PROBLEMS WITH HIS LEFT HIP IMPLANT. PATIENT WANTS TO KNOW IF IMPLANTS ARE PART OF RECALL UPDATE: PATIENT IS EXPERIENCING CHRONIC PAIN. HE HAS TO USE A WHEEL CHAIR WHEN HE WALKS FOR A LONG PERIOD OF TIME. UPDATE: IT WAS REPORTED BY THE ATTORNEY THAT PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013 AND HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2017 OF THE LFIT V40 HEAD DUE TO ALLEGED ALTR.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain; Reaction

  MAUDE report 8460883 ↗
• InjuryJan 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE ATTORNEY THAT PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6), 2013 AND HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2017 OF THE LFIT V40 HEAD DUE TO ALLEGED ALTR.

  Patient problems: Injury; Reaction

  MAUDE report 8272519 ↗
• InjurySep 26, 2018Degraded; Insufficient Device Problem Information; Degraded; 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 LEFT HIP ON OR ABOUT (B)(6) 2013. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE, EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. PATIENT HAS NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE FEMORAL HEAD.

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

  MAUDE report 7912120 ↗
• InjuryJan 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  FEMORAL SHAFT FRACTURE OF TOTAL RIGHT HIP.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7161646 ↗
• MalfunctionAug 2, 2017Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A PRIMARY IMPLANT OF THE ACCOLADE II 132 ANGLE STEM, BOTH OUTER AND INNER PACKAGING WERE FOUND TO BE COMPROMISED. SURGEON USED A 127 ANGLE STEM INSTEAD. SURGICAL DELAY WAS REPORTED TO BE UNDER 5 MINUTES WITH NO ADVERSE AFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6759733 ↗
• InjuryMar 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REPORTED A REVISION OF A HIP FRACTURE DUE TO FALL.

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

  MAUDE report 6404865 ↗
• MalfunctionFeb 7, 2017Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

  IT WAS REPORTED ON THE IMPLANT, LOOKS LIKE FRIZZY WHITE COTTON LIKE MATERIAL. IT WAS REPORTED THEY DECIDED NOT TO IMPLANT AND ALLEGEDLY KEPT IMPLANT AND ORIGINAL BOX.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6307144 ↗