Biolox 6570-0-536Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540608574), received between Aug 27, 2020 and Dec 8, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Unstable” (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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO AN INFECTION DR. REMOVED THE FOLLOWING ITEM: 6570-0-536, LOT: 29826453. THERE IS NO NOTICEABLE DAMAGE OR WEAR. HOSPITAL WILL NOT RELEASE PT INFO NOR THE EXPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 23743737 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 23478991 ↗
• InjurySep 29, 2025Mechanical Problem; Mechanical Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED BECAUSE THE PATIENT FELT HER RIGHT LEG WAS SHORTER THAN THE LEFT. A STEM, HEAD AND LINER WERE REVISED. REP CONFIRMED THAT THERE WERE 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; Unequal Limb Length

  MAUDE report 23166036 ↗
• InjuryFeb 21, 2022Degraded; Material Discolored; Degraded; Material Discolored

  EIGHT YEARS AGO, ACCOLADE TMZF, TRIDENT HEMISPHERICAL HA CLUSTER AND X3 LINER WERE IMPLANTED. THE CUP WAS FOUND TO BE LOOSE AND MIGRATING UPWARD, SO ONLY THE CUP AND HEAD WERE REVISED. WHEN THE HEAD WAS REMOVED, BLACK DISCOLORATION WAS OBSERVED AT THE INTERFACE BETWEEN THE DELTA CERAMIC AND THE ACCOLADE TMZF. THE SURFACE OF THE CUP WAS SO SMOOTH THAT THE COATING WAS GONE ONLY ON THE LOWER PART. IT SEEMS THAT THE STRESS WAS APPLIED TO THE CUPS AND DISPERSED TO THE HEAD AND NECK. THERE HAS BEEN NO EXPERIENCE OF DISCOLORATION DUE TO WEAR ON DELTA CERAMIC HEADS (NOT A METAL HEAD).

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 13573619 ↗
• InjuryNov 8, 2021Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AN OFFICE NOTE CITES THE FOLLOWING: LEFT HIP DISCOMFORT, NUMBNESS, LIMB LENGTH DISCREPANCY, SUBLUXATION/ DISLOCATION, STEM SUBSIDENCE. SURGEON REPORTED THAT THE SHELL WAS RETROVERTED AND VERTICAL. ALL COMPONENTS WERE REVISED. REP PROVIDED AN OFFICE NOTE AND THE PRIMARY OPERATIVE REPORT AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Numbness; Unequal Limb Length

  MAUDE report 12775537 ↗
• InjuryAug 25, 2021Unstable; Unstable

  IN REPORTING A REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2021, REP WAS NOTIFIED THE PATIENT'S HIP WAS REVISED ON (B)(6) 2011 DUE TO INSTABILITY. A 36 +2.5 CERAMIC HEAD WAS REVISED TO A 36 +10 METAL HEAD. THE LINER WAS RETAINED. REP PROVIDED PRIMARY AND REVISION USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12367868 ↗
• InjuryJul 7, 2021Adverse 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 PROXIMAL FEMORAL OSTEOLYSIS AND DISCOMFORT IN THE GROIN AND ANTERIOR LATERAL HIP REGION. A CEMENTED STEM, HEAD, AND LINER WERE REVISED. REP PROVIDED USAGE SHEETS AND AN OFFICE VISIT NOTE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Osteolysis; Pain

  MAUDE report 12127884 ↗
• InjuryMar 17, 2021Fracture; Fracture

  AS REPORTED: "DR...PERFORMED A LEFT HIP REVISION DUE TO GROSS TRUNNION FAILURE AND FRACTURED BIOLOX HEAD. NO MORE INFORMATION IS AVAILABLE PER DOCTOR. IMPLANT IS NOT AVAILABLE PER HOSPITAL POLICY" A 36 + 2.5 MM BIOLOX CERAMIC V40 HEAD, SIZE 5 132° ACCOLADE II HIP STEM, AND 36F LINER WERE REVISED. SPOKE TO REP: THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. CONFIRMED THAT OTHER THAN ATTACHED EXPLANT PICTURES AND USAGE SHEET, NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 11507494 ↗
• InjuryAug 27, 2020Unstable; Unstable

  PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2020. PATIENT UNDERWENT REVISION RIGHT TOTAL HIP FOR INSTABILITY ON (B)(6) 2020. HEAD, LINER AND STEM EXCHANGED.

  Patient problems: Injury; Joint Dislocation; Joint Laxity

  MAUDE report 10458124 ↗