Accolade 6020-0130Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540510532), received between Aug 1, 2017 and Dec 11, 2025 — classified as 6 injuries.

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

• InjuryDec 11, 2025Degraded; Material Erosion; Degraded; Material Erosion

  THE FOLLOWING INFORMATION WAS PROVIDED: PT. REPORTED; I JUST HAD A TOTAL HIP REVISION SURGERY TO REPLACE THE L FIT ANATOMIC V40 THAT APPARENTLY HAD BEEN RECALLED. PT. MENTIONED SHE HAD BEEN IN A LOT OF PAIN WITH CLICKING AND GRINDING. STATED THAT BLACK FLUID POURED OUT WHEN THE IMPLANT WAS REMOVED.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 23783420 ↗
• InjurySep 23, 2024Degraded; Degraded

  AS REPORTED BY THE REP: "IT WAS A COMBINATION OF AN ACCOLADE 1 STEM AND COCR +HEAD. IT LOOKS LIKE THE PATIENT IS POTENTIALLY LOOKING TO CHECK/PURSUE ANY INCOMPATIBILITY AS THEY EXPERIENCED METALLOSIS. I HAVE FORWARDED THE HIP COMPOSITION GUIDE. RIGHT HIP: EVENT WAS NOTICED VIA MRI DONE AT CLINIC WHICH SHOWED PSEUDOTUMOR AND ELEVATED METAL ION LEVELS. ELEVATED METAL ION LEVELS (BOTH COBALT AND CHROMIUM ELEVATED) POST PRIMARY SURGERY. DURING REVISION SURGERY, TRUNNIONOSIS WAS NOTED."

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 20285785 ↗
• InjuryMar 18, 2024Material Erosion; Device Dislodged or Dislocated; Material Erosion; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "THE PATIENT REPORTED PAIN AND DISCOMFORT IN HER LEFT HIP, X-RAYS SHOWED A SIZE 1 ACCOLADE TMZF STEM WITH A 32+12 V40 FEMORAL HEAD DISASSOCIATED FROM THE TRUNNION, SHE WAS BROUGHT TO THE OPERATING ROOM FOR A REVISION SURGERY, THE FEMORAL HEAD WAS FOUND TO BE DISASSOCIATED FROM THE STEM, THERE WAS DAMAGE TO SOME OF THE SOFT TISSUES AND METALLOSIS FINDINGS, A FEMORAL REVISION WAS PERFORMED UTILIZING ANOTHER COMPANY¿S IMPLANT, THE ACETABULAR COMPONENT WAS STRYKER AND WAS RETAINED, A LINER EXCHANGE WAS PERFORMED ON THE TRIDENT ACETABULAR CUP, IT WAS A SIZE D ALPHA CODE. NO FURTHER INFORMATION IS AVAILABLE OR IMPLANTS DUE TO FACILITY POLICY. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18921742 ↗
• InjuryNov 13, 2020Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component

  THA IMPLANT FAILURE AT THE NECK-HEAD JUNCTION. SEVERE ACCOLADE TAPER CORROSION AND BEFORE THE SURGERY CORROSION HAS CAUSED SEVERE PAIN. R REVISED THE STEM AND HEAD AND USED BIGGER ACCOLADE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 10834912 ↗
• InjuryJul 2, 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 RIGHT HOP ON OR ABOUT (B)(6) 2009 AND WAS REVISED ON (B)(6) 2016. IT IS FURTHER ALLEGED THAT SHE SUFFERED AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICES AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

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

  MAUDE report 8752398 ↗
• InjuryAug 1, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  PHYSICIAN USED BROACHES AS USUAL, STARTING FROM SIZE 0 AND STOPPED WHEN REACHED SIZE 1. CONFIRMED BY A SURGEON, THE PHYSICIAN CHOOSES A SIZE 1 FOR THE PROSTHESIS. THE PROSTHESIS THAT WAS OPENED, SIZE 1, DID NOT FIT THE FEMUR CANAL. BUT SURGEON PROCEED WITH THE SURGERY AND CLOSED THE INCISION. WHEN FINISHED, A SURGEON MEASURED THE LEG, AND FOUND THAT THE LEG WAS NOT THE SAME LENGTH (ABOUT 1.5CM LONGER). TO SOLVE THIS THE SURGEON NEEDED TO REOPEN THE SURGERY, WHICH WAS 2.5 HOURS LATER BECAUSE THE SURGEON NEEDED TO RESTERILIZE A SET. THE SURGEON REMOVED THE STEM AND COMPARED THE PROSTHESIS SIZE WITH THE BROACH. THE PHYSICIAN STATED THAT THE PROSTHESIS SIZE 1 THAT WAS OPENED EARLIER WAS ACTUALLY A SIZE 2. SURGEON RE-RASPED A FEMUR USING A SIZE 2 BROACH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE SAME PROSTHESIS. PATIENT WAS SENT TO ICU AFTER THE SURGERY BECAUSE OF 9 HOURS OF OPERATION UNDER A GENERAL ANESTHESIA.

  Patient problems: Injury

  MAUDE report 6759074 ↗