Accolade 6720-0330Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04546540664464), received between Sep 12, 2017 and Jul 9, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT HAD A RIGHT PRIMARY THA ON (B)(6) 2025.PATIENT HAD A FEMUR PERI-PROSTHETIC FRACTURE TYPE B2. PATIENT WAS REVISED ON (B)(6) 2025.ONLY FEMORAL COMPONENT AND HEAD WERE REVISED.

  Patient problems: Periprosthetic fracture

  MAUDE report 25766626 ↗
• InjurySep 23, 2024Degraded; Osseointegration Problem; Degraded; Osseointegration Problem

  ON OR ABOUT (B)(6) 2014, A REGISTERED NURSE, TRIPPED AND FELL AT THE HOSPITAL LANDING ON HER RIGHT HIP. AS A RESULT OF THE ACCIDENT, SHE FRACTURED HER RIGHT HIP AND REQUIRED HER TO UNDERGO A TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2014 WHERE SHE HAD A STRYKER LFIT V40 HEAD IMPLANTED INTO HER BODY. ON (B)(6) 2017 PLAINTIFFS ORTHOPEDIC SURGEON ADVISED HER OF THE ELEVATED LEVELS OF COBALT AND CHROMIUM IN HER BLOODWORK. PATIENTS RIGHT HIP HAS NOT YET BEEN REVISED.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 20277168 ↗
• InjuryJun 7, 2024Material Erosion; Material Erosion

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2017, AND WAS IMPLANTED WITH AN LFIT V40 COCR FEMORAL HEAD AND ACCOLADE II HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED PAIN, ELEVATED SERUM COBALT AND CHROMIUM LEVELS AND METALLOSIS.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19482730 ↗
• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEUROLOGICAL AND VASCULAR DISORDERS ON (B)(6) 2019.

  Patient problems: Unspecified Nervous System Problem; Unspecified Vascular Problem

  MAUDE report 16443582 ↗
• InjuryApr 11, 2022Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2015 AND WAS REVISED ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 14071191 ↗
• InjuryFeb 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT "A PATIENT CLAIMED THAT THEIR TOTAL HIP REPLACEMENT BROKE IN 2 PLACES 9-10 DAYS AFTER PROCEDURE WITHOUT ANY INJURY OR FALL". PATIENT PRESENTING WITH PAIN. UPDATE FROM SALES REP SUGGESTS THE 'FRACTURES' MENTIONED PROBABLY REFER TO THE FEMORAL BONE AND NOT THE ACCOLADE 2 STEM."

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 13422985 ↗
• InjuryJan 6, 2022Degraded; Degraded

  AS REPORTED: "PT PRESENTED WITH COMPLAINTS OF PAIN FOLLOWING MULTIPLE-DISLOCATIONS. PT HAD HER HIP REPLACED 'ABOUT A YEAR AGO'. HER HIP HAS DISLOCATED 'MORE THAN A HALF A DOZEN TIMES SINCE THEN'. TOOK CULTURE-SWABS TO RULE OUT INFECTION. HE SUSPECTS 'SOME SORT OF METALOSIS-REACTION', FOLLOWING DEBRIDEMENT OF 'NECROSED-LOOKING TISSUE." A 46MM HA HEMI SHELL, 35MM TORX SCREW, 25 MM TORX SCREW, "C" INSERT FOR A 28 MM HEAD, AND 28 + 8MM LFIT HEAD WERE REVISED. THE STEM IS WELL-FIXED AND WAS LEFT IN-SITU. PATIENT WAS REVISED TO A 52E CLUSTERHOLE SHELL WITH 3 SCREWS, A 36E LINER, AND BIOLOX 36 +7.5 MM HEAD. SPOKE TO REP: SURGEON ORIGINALLY SUSPECTED THE PATIENT SUFFERED MULTIPLE DISLOCATIONS DUE TO SHELL MALPOSITION. HOWEVER, INTRA-OPERATIVELY, SURGEON FOUND SIGNS OF METAL ON METAL WEAR AND A POSSIBLE ALLERGIC REACTION OR INFECTION ARE THOUGHT TO BE POSSIBLE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 13181947 ↗
• InjuryJul 8, 2021Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED. THE STEM IMPLANTED 2 DAYS PRIOR TO THE REVISION WAS TOO SMALL FOR THE PATIENT'S ANATOMY AND SUBSIDED SOMEWHAT. THE SHELL WAS IMPLANTED IN TOO VERTICAL A POSITION AND NEEDED ITS POSITION ALTERED. A LARGER STEM AND (DUE TO NEEDING TO RE-REAM TO RE-POSITION THE SHELL) LARGER SHELL WERE IMPLANTED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12133394 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. HAD A PERIPROSTHETIC FX OF A RIGHT HIP ORIGINAL DONE ON (B)(6) 2021. HE CABLED THE BONE AND CEMENTED THE EXISTING STEM. SPOKE TO REP: THE PERI-PROSTHETIC FRACTURE WAS NOT ATTRIBUTED TO INACCURATE BONE CUTS AT THE PRIMARY SURGERY OR ANY BONE PIN HOLES. NOTHING WAS EXPLANTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 11768441 ↗
• InjuryApr 9, 2021Material Erosion; Fracture; Noise, Audible; Material Erosion; Fracture; Noise, Audible

  IT HAS BEEN REPORTED "ON (B)(6) 2021, THE PATIENT FELT THE CLICK OF HER RIGHT HIP WHILE WALKING. SHE WAS UNABLE TO CONTINUE WALKING" AS REPORTED BY THE SALES REP "AS YOU CAN SEE ON THE COMPLAINT FORM THERE WAS IMPLANTED AESCULAP HEAD (COMPETITOR'S HEAD) ON A ACCOLADE STEM"

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11642625 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: (B)(6) AFTER BHA. (4/4)

  Patient problems: Unspecified Infection

  MAUDE report 11404188 ↗
• InjuryDec 18, 2020Adverse 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. AN ACCOLADE STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, FEMORAL HEAD, ADM/ MDM POLY INSERT, AND MDM METAL LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 11035496 ↗
• 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 RIGHT FEMUR PERIPROSTHETIC. FRACTURE. THE PATIENT UNDERWENT RIGHT HIP REVISION, FEMORAL COMPONENT AND CERAMIC HEAD WERE EXCHANGED (B)(6) 2019.

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

  MAUDE report 9659138 ↗
• InjuryJan 13, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO STEM SUBSIDENCE. THE PATIENT'S HEMI HIP CONSTRUCT WAS REVISED TO A TOTAL HIP WITH A RESTORATION MODULAR STEM CONSTRUCT (THERE ARE NO ALLEGATIONS AGAINST THE MODULAR ENDO HEAD OR SLEEVE). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 9584514 ↗
• InjuryNov 28, 2019Migration; Migration

  PATIENT'S HIP WAS REVISED DUE TO "SUBSIDED FEMORAL STEM." REP PROVIDED A PER FORM WITH AN ACCOLADE II STEM, 36 +0 BIOLOX HEAD, AND X3 10° INSERT IN THE PRODUCTS SECTION.

  Patient problems: Injury

  MAUDE report 9390222 ↗
• InjuryJan 23, 2019Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "LEFT HIP [REVISION] - THIGH PAIN, LOOSE PROSTHESIS PROBABLE". A 36 0° X3 INSERT, 50MM TRITANIUM SHELL, 36 +5 BIOLOX V40 HEAD, AND ACCOLADE II #3 132° WERE REVISED TO COMPETITOR DEVICES.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8271779 ↗
• InjuryMar 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF TOTAL HIP REPLACEMENT DUE TO PERI-PROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7307415 ↗
• InjurySep 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD PRIMARY TOTAL HIP REPLACEMENT AND NEEDED TO RETURN TO THE OR IN 3 WEEKS DUE TO A B2 PERI-PROSTHETIC FEMUR FRACTURE. FEMORAL COMPONENT AND HEAD WERE REPLACED.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6858878 ↗