Biolox 6570-0-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04546540608482), received between Oct 16, 2017 and Oct 20, 2025 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 23334528 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2025: THE STAINLESS HEAD WAS CORRECT, THE ITEMS LISTED BELOW (STRYKER LINER AND CERAMIC HEAD) IS WHAT WAS TAKEN OUT DURING REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 22825098 ↗
• InjuryDec 20, 2022Corroded; Degraded; Naturally Worn; Corroded; Degraded; Naturally Worn

  AS REPORTED: "HEAD & LINER WERE EXCHANGED DURING AN IRRIGATION AND DEBRIDEMENT MEANT FOR INFECTION. STRIPE WEAR PRESENT ON CERAMIC & LINER. SURGEON REPORTED CORROSION PRESENT ON NECK/TRUNNION OF FEMORAL STEM".

  Patient problems: Unspecified Infection

  MAUDE report 16013359 ↗
• InjuryJun 28, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY CAUSED BY INCORRECT SELECTION (IMPLANTS WERE TOO SHORT/ DID NOT HAVE ENOUGH OFFSET FOR PATIENT'S ANATOMY). REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE IMPLANTS. AN ACCOLADE II STEM AND BIOLOX HEAD WERE REVISED. REP CONFIRMED THAT PRIMARY USAGE MAY BE ABLE TO BE PROVIDED, OTHERWISE, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14839305 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "RIGHT HIP REVISED DUE TO INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." REP PROVIDED USAGE SHEETS FROM THE CURRENT AND PRIOR (REVISION OF COMPETITOR IMPLANTS) REVISIONS. A BIOLOX HEAD AND COMPETITOR LINER WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 13859359 ↗
• InjuryMar 1, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  PATIENT HAD LEFT INDEX THA IN (B)(6) 2021. PATIENT PRESENTS WITH RECURRENT INSTABILITY. UNDERGOES REVISION ON (B)(6) 2021. FINDINGS: INSTABILITY AND HETEROTOPIC OSSIFICATION. ONLY HEAD, AND LINER ARE EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Joint Laxity

  MAUDE report 13629019 ↗
• InjuryFeb 27, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  PATIENT HAD LEFT INDEX THA IN (B)(6), 2021. PATIENT PRESENTS WITH INSTABILITY. UNDERGOES REVISION ON (B)(6) 2021. ONLY HEAD AND LINER ARE EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Joint Laxity

  MAUDE report 13615018 ↗
• MalfunctionFeb 9, 2022Fracture; Fracture

  THE HEAD WAS FRACTURED WHEN IT WAS DRIVEN INTO THE STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13500686 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "DR...PERFORMED A LEFT HIP REVISION DUE TO SOFT TISSUE BETWEEN THE HEAD AND LINER. BIOLOX HEAD WAS EXPLANTED. IMPLANTS ARE NOT AVAILABLE DUE TO HOSPITAL POLICY AND NO MORE INFORMATION IS AVAILABLE PER DOCTOR."

  Patient problems: Insufficient Information

  MAUDE report 11675000 ↗
• InjuryOct 17, 2019Mechanical Problem; Mechanical Problem

  PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL HIP REPLACEMENT (B)(6) 2016. PATIENT HAD MECHANICAL FAILURE OF RIGHT HIP AND UNDERWENT REVISION SURGERY TO TREAT PAIN AND DYSFUNCTION (B)(6) 2019. ONLY THE HEAD AND STEM WERE EXCHANGED.

  Patient problems: Injury; Pain

  MAUDE report 9202284 ↗
• MalfunctionMay 6, 2019Fracture; Fracture

  REP REPORTED THAT A BIOLOX DELTA V40 FEMORAL HEAD ALLEGEDLY FRACTURED INTO PIECES WHEN IMPACTED ONTO THE TRUNNION OF AN EXETER STEM. DELAY OF 1 MINUTE TO SURGERY WHILST ANOTHER FEMORAL HEAD IMPLANT WAS SOURCED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8582712 ↗
• InjuryNov 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON REPORTS PATIENT FR A STATUS POST RIGHT TOTAL HIP REPLACEMENT DONE ON (B)(6) 2018 WAS COMPLAINING HER HIP SEEMED TO BE SHORT AND WOULD LIKE TO HAVE IT LENGTHENED. IT WAS UNDETERMINED IF THE STEM SUBSIDED. REGARDLESS THE SURGEON DECIDED TO TRY TO LENGTHEN THE LEG BY GOING TO A LONGER HEAD SIZE. THE PROCEDURE WAS PERFORMED THROUGH THE ANTERIOR APPROACH. THE HEAD WAS REMOVED AND THE STEM WAS DETERMINED TO BE WELL FIXED. A +7.5 36MM HEAD WAS TRIED REPLACING THE ORIGINAL HEAD LENGTH. IT WAS DETERMINED THE LEG LENGTHS WERE NOW EQUAL AND THE NEW HEAD WAS IMPACTED AND THE SURGICAL SITE CLOSED.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8065002 ↗
• InjuryJul 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S HIP WAS REVISED. AN LFIT METAL HEAD AND SIZE F 0° LINER WERE IMPLANTED.

  Patient problems: Injury

  MAUDE report 7711192 ↗
• MalfunctionOct 16, 2017Scratched Material; Insufficient Device Problem Information; Scratched Material; Insufficient Device Problem Information

  DURING A TOTAL HIP REPLACEMENT PROCEDURE, IMMEDIATELY AFTER THE CERAMIC HEAD WAS SECURED TO THE NECK OF THE FEMORAL STEM, THE PHYSICIAN ASSISTANT OBSERVED A THIN LINEAR MARK AT THE BASE OF THE HEAD. THE SURGEON ASKED IF IT WAS A CRACK. HE REMOVED THE FEMORAL HEAD AND EXAMINED THE MARK. HE COULD NOT DETERMINE IF THE MARK WAS A FRACTURE SO HE REQUESTED ANOTHER FEMORAL HEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6952450 ↗