Accolade 6020-0637Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540510587), received between Apr 1, 2019 and Nov 6, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Degraded” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2009 AND WAS IMPLANTED WITH A LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HE WAS REVISED ON (B)(6) 2024, DUE TO ALLEGED FEMORAL HEAD DISSOCIATION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 20623509 ↗
• InjuryMar 3, 2022Adverse 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 A FEMORAL PERIPROSTHETIC FRACTURE. A STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM, A NEW HEAD, AND AN ADM/ MDM LINER CONSTRUCT. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND INSERT. REP REPORTED THAT HE CAN PROVIDE PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 13664480 ↗
• InjuryApr 21, 2021Degraded; Material Erosion; Detachment of Device or Device Component; Insufficient Device Problem Information; Degraded; Material Erosion; Detachment of Device or Device Component; 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), 2009 AND WAS REVISED ON (B)(6), 2020. 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: Metal Related Pathology; Unspecified Infection

  MAUDE report 11704558 ↗
• InjuryNov 25, 2020Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  DR. REPORTED: "DISASSEMBLY OF THE PROSTHETIC IMPLANT LEFT HIP ON (B)(6) 2020. PROSTHETIC IMPLANT WORN. ON (B)(6) 2020, PATIENT OPERATED FOR REVISION. PERIPROSTHETIC METALLOSIS WITH WEAR OF THE FEMORAL NECK OF THE STEM. STEM AND HEAD EXPLANTED AND REPLACED WITH A REVISION PROSTHETIC".

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology

  MAUDE report 10902783 ↗
• InjuryFeb 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO TRUNNION WEAR. INTRA-OPERATIVELY, EXCESSIVE METALLOSIS WAS OBSERVED.

  Patient problems: Injury

  MAUDE report 9671150 ↗
• InjuryJul 15, 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 HIS RIGHT HIP ON OR ABOUT (B)(6) 2008 AND WAS REVISED ON (B)(6) 2010. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

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

  MAUDE report 8789306 ↗
• InjuryApr 1, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED 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) 2019. IT IS FURTHER ALLEGED THAT HE 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: Injury; Metal Related Pathology; Reaction; Unspecified Infection

  MAUDE report 8470189 ↗