Biolox 6570-0-128Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540608499), received between Aug 28, 2018 and Jun 23, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2025Fracture; Fracture

  A PATIENT WITH A BHA ON (B)(6) 2025. ON (B)(6) 2025, IT WAS DISCOVERED THAT THE DELTA CERAMIC HEAD WAS PARTIALLY DAMAGED. THE PHYSICIAN PLANS TO FOLLOW-UP AT THIS TIME. OTHER THAN THE DAMAGED IMPLANTS, THERE HAVE BEEN NO PATIENT SYMPTOMS OR OTHER HEALTH PROBLEMS TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22305471 ↗
• InjuryMay 23, 2024Adverse 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 INFECTION. A BIOLOX FEMORAL HEAD WAS REVISED TO A NEW HEAD AND SLEEVE (ANY ACETABULAR COMPONENTS REVISED WERE COMPETITOR IMPLANTS). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 19383326 ↗
• InjuryJun 30, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED. AS REPORTED: "LEG LENGTH DISCREPANCY." A STEM, HEAD, AND LINER WERE REVISED. RIGHT SIDE.

  Patient problems: Insufficient Information; Unequal Limb Length

  MAUDE report 14881863 ↗
• InjuryJun 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. COMPARING THE USAGE SHEETS FROM THE CURRENT AND PREVIOUS SURGERIES INDICATES A 28 +0 BIOLOX HEAD AND 46F ADM/ MDM POLY INSERT WERE REVISED TO A 28 +4 LFIT V40 HEAD AND ANOTHER 46F ADM/ MDM POLY INSERT.

  Patient problems: Injury

  MAUDE report 10147590 ↗
• InjuryMar 9, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THROUGH THE SUBMISSION OF A USAGE SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. IN COMPARING THE REVISION USAGE SHEET WITH A PREVIOUS REVISION USAGE SHEET , A 28 +0 BIOLOX HEAD AND 42E ADM/ MDM INSERT WERE REVISED TO A 28 +4 BIOLOX HEAD AND ANOTHER 42E ADM/MDM INSERT. UPDATE: "THE PATIENT WAS REVISED TO A 28 +4 LFIT HEAD AND THE SAME 42 E LINER SHE HAD IN BEFORE. REASON FOR THE REVISION WAS AN INTER-PROSTHETIC DISLOCATION. THE 28 +0 BIOLOX HEAD THAT WAS ORIGINALLY IMPLANTED BECAME DISASSOCIATED FROM THE MDM INSERT. THERE WAS NO NOTICEABLE WEAR OR DAMAGE TO THE MDM INSERT. THE IN/OUT IMPLANTS WERE BECAUSE THE DOCTOR DECIDED TO CHANGE THE FEMORAL HEAD SIZE TO ADD MORE STABILITY. HE ELECTED NOT TO TRIAL AT FIRST BUT THEN WANTED TO CHANGE THE LENGTH. NO EXPLANTED PRODUCTS ARE AVAILABLE FOR RETURN PER HOSPITAL POLICY."

  Patient problems: Injury

  MAUDE report 9805360 ↗
• InjuryFeb 5, 2020Fracture; Fracture

  THE PATIENT HAD ALREADY A ACCOLADE II STEM AND A TITANIUM CUP. THE SURGEON WANTED TO REPLACE THE HEAD AND INSERT BY A CONSTRAINED LINER AND NEW HEAD. WHEN BOTH IMPLANTS WERE PLACED, THE SURGEON TESTED STABILITY, BUT THE BIPOLAR HEAD OF THE CONSTRAINED LINER BECAME LOOSE FROM THE LINER. WHEN HE REMOVED THE CERAMIC HEAD FROM THE STEM , THE HEAD BROKE. TO SOLVE ALL THIS , WE TOOK ANOTHER CONSTRAINED LINER , WITH A METAL 22MM HEAD. UPDATE PER RESPONSE: SURGICAL DELAY 1 HOUR.

  Patient problems: Injury

  MAUDE report 9671658 ↗
• MalfunctionJan 7, 2019Device Handling Problem; Device Handling Problem

  THE CLINIC REPORTED THE FOLLOWING EVENT : "IMPLANTATION FAILURE. THEY COULDN'T HAVE IMPACTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8222762 ↗
• InjuryAug 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CALLED STATING HE HAD A LEFT HIP IMPLANT ON (B)(6) 2015 AND WAS REVISED TO COMPETITIVE DEVICES ON (B)(6) 2016. PATIENT WILL NOT PROVIDE FURTHER INFORMATION. UPDATE: ADDITIONAL INFORMATION RECEIVED: ALL THE PARTS ON THE LIST WERE REMOVED (B)(6) 2016 EXCEPT FOR THE FEMORAL STEM. THE REVISION WAS DONE TO LEG LENGTH OF 15MM TO 20MM.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 7822978 ↗