Accolade 6021-5537Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04546540510778), received between Jun 19, 2018 and Dec 12, 2024 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2011 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HIS LEFT HIP WAS REVISED ON (B)(6) 2023 ALLEGEDLY DUE TO HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 20920454 ↗
• InjurySep 17, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  SEPARATION OF STEM FROM HEAD DUE TO BROKEN TRUNNION.

  Patient problems: Insufficient Information

  MAUDE report 20240445 ↗
• InjuryJun 6, 2023Degraded; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Migration; Degraded; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON (B)(6) 2012, THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD AND AN ACCOLADE HA HIP STEM. IT IS FURTHER ALLEGED THE PATIENT HAD ELEVATED COBALT AND CHROMIUM LEVELS AND WAS REVISED ON (B)(6) 2022.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology; Pain; Unequal Limb Length

  MAUDE report 17069422 ↗
• InjuryMay 27, 2022Corroded; Degraded; Material Erosion; Corroded; Degraded; 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: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 14520826 ↗
• InjuryApr 11, 2022Corroded; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Corroded; Loss of Osseointegration; 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 HIS LEFT HIP ON OR ABOUT (B)(6)2006 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

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

  MAUDE report 14073769 ↗
• InjuryJan 25, 2022Material Erosion; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Erosion; Detachment of Device or Device Component; 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 HIS RIGHT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2021. 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; Metal Related Pathology

  MAUDE report 13340753 ↗
• InjuryMar 25, 2021Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO STEM FAILURE. INTRAOPERATIVELY, TRUNNION WEAR, METALLOSIS, HEAD TOGGLING ON TRUNNION, BLACK TISSUE, AND A BROKEN INSERT WERE NOTED. A 44 MM +4 V40 HEAD, TMZF PLUS STEM, AND 0° 44F INSERT WERE REVISED. REP CONFIRMED THAT ASIDE FROM PROVIDED PRIMARY USAGE SHEET, NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 11572176 ↗
• InjuryOct 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REVISED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN AND SQUEAKING. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: EXTREME AMOUNT OF BLACK TISSUE THE SURGEON REPORTED AS METALLOSIS, SEVERE TRUNNION WEAR, CORROSION, AND DISASSOCIATION OF THE FEMORAL HEAD FROM THE STEM. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A CERAMIC HEAD AND POLY LINER. REP CAN PROVIDE ADDITIONAL PICTURES. THE REVISED STEM AND HEAD ARE ALLEGEDLY AVAILABLE FOR RETURN. REP CONFIRMED THAT THERE ARE 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; Foreign Body Reaction; Inflammation; Joint Dislocation; Metal Related Pathology; Pain

  MAUDE report 10626022 ↗
• InjuryJul 10, 2020Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SEVERE TRUNNIONOSIS. INTRA-OPERATIVELY, BLACK TISSUE WAS NOTED IN THE PATIENT. 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 LINER.

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

  MAUDE report 10256701 ↗
• InjuryMay 28, 2019Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  T WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNIONOSIS. PRE-OP X-RAYS SHOW THE HEAD DISASSOCIATED FROM THE STEM. INTRA-OPERATIVELY, BLACK TISSUE WAS NOTED IN THE PATIENT. NO LINER WEAR OR DISCOLORATION WERE REPORTED. THE STEM, HEAD AND LINER WERE REVISED TO A STRYKER LINER WITH A COMPETITOR STEM AND HEAD. REP PROVIDED A PRE-REVISION X-RAY AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury

  MAUDE report 8648009 ↗
• InjuryMay 21, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE TRUNNION OF THE STEM BREAKING OFF, DISCONNECTING THE STEM FROM THE HEAD. INTRA-OPERATIVELY, A LITTLE BLACK TISSUE WAS NOTED IN THE PATIENT ALONG WITH DAMAGE TO THE POLY LINER. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A CERAMIC HEAD. REP PROVIDED A PRIMARY OPERATIVE REPORT, PRE- REVISION X-RAYS, AND EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8628882 ↗
• InjuryDec 5, 2018Material Erosion; Insufficient Device Problem Information; Material Erosion; Insufficient Device Problem Information

  IT WAS REPORTED, THROUGH THE FILING OF A LAWSUIT, THAT THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP AND WAS LATER REVISED. IT IS ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE, DEVICE RECALL, AND EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HIS BLOOD.

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

  MAUDE report 8135188 ↗
• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 LEFT HIP ON (B)(6) 2011 AND WAS REVISED ON (B)(6) 2015. IT IS FURTHER ALLEGED THAT THE PATIENT SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

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

  MAUDE report 7968755 ↗
• InjuryOct 3, 2018Insufficient Device Problem Information; 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) 2007 AND WAS REVISED ON (B)(6) 2016. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL, EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HIS BLOOD.

  Patient problems: Injury; Reaction

  MAUDE report 7931636 ↗
• InjurySep 26, 2018Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; 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) 2008 AND WAS REVISED ON (B)(6) 2011. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7911690 ↗
• InjuryAug 1, 2018Degraded; Mechanical Problem; Material Deformation; Degraded; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT PATIENTS' LEFT HIP WAS REVISED DUE TO TRUNNIONOSIS AND DISASSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, REP REPORTED THE PRESENCE OF BLACK TISSUE IN THE PATIENT.

  Patient problems: Injury; Reaction

  MAUDE report 7740306 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  NOTICE RECEIVED FROM PATIENT'S ATTORNEY ALLEGES THAT PATIENT HAD A STRYKER HIP PROSTHESIS WHICH WAS SUBJECT TO STRYKER'S RECALL. IT IS ALLEGED THAT THE PATIENT WOUND UP HAVING MANY OF THE SIGNS AND SYMPTOMS STRYKER SAID THE DEFECTIVE HIP WOULD CAUSE IN ITS RECALL NOTICE AND IN CONSULTATION WITH HIS ORTHOPAEDIC SURGEON HAS HAD A NUMBER OF PROCEDURES TO ADDRESS THE SIGNS AND SYMPTOMS HE WAS DISPLAYING, ULTIMATELY RESULTING IN THE PROSTHESIS BEING REMOVED.

  Patient problems: Injury

  MAUDE report 7614171 ↗