Accolade 6021-0130Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540510662), received between Aug 28, 2018 and Jul 31, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  HEAD DISSOCIATED FROM TRUNNION - TRUNNION WAS WORN AND REPLACED WITH COMPETITOR. LINER WAS REPLACED WITH MDM LINER.

  Patient problems: Insufficient Information

  MAUDE report 22673844 ↗
• InjuryOct 17, 2024Degraded; Fracture; Detachment of Device or Device Component; Degraded; Fracture; Detachment of Device or Device Component

  THA WAS PERFORMED ON (B)(6) 2012. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO BROKEN OF THE STEM NECK.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 20477197 ↗
• InjuryJun 29, 2024Corroded; Material Erosion; Corroded; Material Erosion

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON (B)(6) 2007 AND WAS REVISED ON (B)(6) 2019 DUE TO PAINFUL RIGHT TOTAL HIP ARTHROPLASTY, CORROSION AT THE HEAD/NECK JUNCTION WITH ADVERSE LOCAL TISSUE REACTION, AND DEVICE RECALL.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19640555 ↗
• InjuryJul 6, 2022Adverse 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 HER RIGHT HIP ON OR ABOUT (B)(6) 2009 AND WAS REVISED ON JULY 1, 2020. IT IS FURTHER ALLEGED THAT SHE 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 HER BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 14926579 ↗
• InjuryMar 23, 2022Fracture; Fracture

  THE FOLLOWING WAS REPORTED: REVISION SURGERY FOR BROKEN RIGHT HIP PROSTHETIC STEM COLLAR.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13859541 ↗
• InjuryAug 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF PRIMARY AND REVISION USAGE SHEET'S THAT THE PATIENT'S RIGHT HIP WAS REVISED. A 42 MM 'E' MDM CEMENTLESS LINER AND A 42E ADM/MDM X3 INSERT WERE SWAPPED, AND A 28 MM -4 MM LFIT V40 FEMORAL HEAD AND AN ACCOLADE TMZF PLUS HIP STEM WERE REVISED TO A CERAMIC 28MM -4 MM V40 FEMORAL HEAD, A RESTORATION MODULAR HIP SYSTEM.

  Patient problems: Injury

  MAUDE report 10366467 ↗
• InjuryNov 5, 2019Insufficient 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 HER LEFT HIP IN 2007. IT IS FURTHER ALLEGED THAT BLOOD WORK DONE IN FALL 2017 REVEALED ELEVATED COBALT LEVELS AND SHE WAS SUBSEQUENTLY DIAGNOSED WITH METALLOSIS. HER LEFT HIP WAS REVISED ON (B)(6) 2018.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9278434 ↗
• InjuryOct 4, 2019Degraded; 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 HER LEFT HIP ON OR ABOUT (B)(6) 2006 AND WAS REVISED ON (B)(6) 2018. 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: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 9155854 ↗
• InjuryJul 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT WHO HAS DID SURGICAL PROCEDURE THA SEVERAL YEARS AGO, BUT THERE IS A SUSPICION OF A PSEUDOTUMOR IN THE COMBINATION OF DELTA CERAMIC HEAD AND ACHOLEDE TMZF, AND THE REVISION SURGERY WAS PLANNED. PSEUDO-TUMOR HAS CONFIRMED IN THE PROXIMAL PART OF THE FIXED STEM. REMOVE THE HEAD, STEM AND POLYETHYLENE LINER AND INSERT A NEW IMPLANT. INSERT ANOTHER SIZE POLYETHYLENE LINER, EXETER STEM AND METAL HEAD.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8775749 ↗
• InjuryFeb 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO ELEVATED CHROMIUM LEVELS, AND SUSPECTED CORROSION OF THE HEAD/ TRUNNION INTERFACE. INTRA-OPERATIVELY, CORROSION WAS CONFIRMED. A STEM, HEAD AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, AND MDM/ADM LINER CONSTRUCT. REP PROVIDED EXPLANT PICTURES AND REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8367224 ↗
• InjuryAug 28, 2018Corroded; Corroded

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO SUSPECTED CORROSION (ION LEVELS NOT REPORTED TO REP). REP WAS NOT PRESENT FOR THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 7823431 ↗