Biolox 6570-0-228Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540608529), received between Aug 16, 2018 and Apr 15, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (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.

• InjuryApr 15, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  DISLOCATION OF HIP, SURGEON HAS REQUESTED THE FEMORAL HEAD BE CHECKED IF IT IS INDEED A +4 HEAD OFFSET. MDM IMPLANTS USED WITH EXETER TRIDENT. THE HEAD DISLOCATED (DISASSOCIATED) FROM THE STEM, BUT ALSO THE INNER HEAD DISENGAGED FROM THE OUTER MDM HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 21839485 ↗
• InjuryApr 23, 2024Unstable; Unstable

  AS REPORTED: "LEFT HIP REVISION. PT. PRESENTED WITH HIP PAIN, SUSPECTED TO BE DUE TO INSTABILITY OF HER ACETABULAR-SHELL IMPLANTS ON (B)(6) 2023 DURING AN ONCOLOGICAL-HEMIPELVECTOMY. DR. OPTED TO REVISE THE SHELL/LINER (COMPETITIVE PRODUCTS), LEAVING OUR FEMORAL STEM IN-SITU. NO COMPLAINTS FILED AGAINST OUR COMPONENTS, NO FURTHER INFO. AVAILABLE." A STRYKER FEMORAL HEAD WAS ALSO REVISED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19162863 ↗
• InjuryFeb 13, 2023Fracture; Fracture

  IT HAS BEEN REPORTED BY THE DISTRIBUTOR THAT "THE PATIENT'S STEM BROKE AT TRUNNION. PATIENT DIDN'T FALL. UPDATE (B)(6) 2023: BOTH THE STEM AND HEAD WERE RETURNED FOR EVALUATION. FRACTURE WAS OBSERVED THROUGH THE NECK OF THE STEM WITH THE FEMORAL HEAD REMAINING LOCKED ON THE STEM TRUNNION. FRACTURE OF THE FEMORAL HEAD WAS OBSERVED WITH TWO DETACHED SECTIONS OF THE HEAD RETURNED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16361156 ↗
• InjuryMar 7, 2022Unstable; Unstable

  PATIENT HAD AN INDEX LEFT THA ON (B)(6) 2021. PATIENT PRESENTED WITH INSTABILITY AND DISLOCATION OF LEFT HIP. UNDERWENT REVISION FOR INSTABILITY ON (B)(6) 2021. CUP, LINER, AND HEAD WERE EXCHANGED.

  Patient problems: Joint Laxity

  MAUDE report 13677955 ↗
• InjuryOct 7, 2020Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: I HAD THA REVISION SURGERY IN 2018. THE STEM WAS REPLACED WITH A STRYKER RESTORATION MODULAR ONE. THE 28 MM CERAMIC FEMORAL HEAD WAS REPLACED WITH A COCR HEAD. HIP, GROIN, AND THIGH PAIN CONTINUED. IN 2019, I WAS DIAGNOSED WITH A STRESS FRACTURE AT THE TIP OF THE PROSTHETIC STEM. IN 2020, I HAD A BONE GRAFT TO REPAIR THE FRACTURE. A CLOUDY MILKY YELLOW FLUID ALONG WITH METAL DEBRIS WAS DISCOVERED IN THE HIP JOINT. ALSO, THERE WAS OSTEOLYSIS IN THE PROXIMAL FEMORAL FEMUR. THE ACETABULAR HAD OVERHANGING SCAR TISSUE AND BONE. THE TRUNION HAD STRIPE WEAR INDICATING IMPINGEMENT AND LIKELY SOURCE OF THE METALLOSIS. THE 28 MM FEMORAL HEAD WAS REPLACED WITH A 40MM COCR HEAD. SYMPTOMS OF METALLOSIS CONTINUE. UPDATE: AS PER THE PATIENT, HE HAD A LEFT THA ON (B)(6) 2016. HE STARTED TO EXPERIENCE PAIN AT THE END OF (B)(6) 2016. THE PATIENT HAD A BONE SCAN DONE ON (B)(6) 2017 (APPROX.) WHICH INDICATED INFECTION/IMPLANT LOOSENING. NO TREATMENT WAS GIVEN TO THE PATIENT. ON (B)(6) 2017 (APPROX.) HE WAS PLACED ON ORAL ANTIBIOTICS FOR 30 DAYS DUE TO INFECTION. ON (B)(6) 2017 X-RAYS CONFIRMED LOOSENING AND THE PATIENT WAS REVISED ON (B)(6) 2018. PATIENT CONTINUED TO EXPERI

  Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection

  MAUDE report 10641224 ↗
• MalfunctionApr 23, 2019Material Fragmentation; Material Fragmentation

  PRIMARY RIGHT HIP PROCEDURE. IT WAS REPORTED THAT AFTER REDUCING THE HIP AND IRRIGATING THE PATIENT, A PINK CHIP WAS NOTICED COMING OUT OF THE PATIENT. PATIENT WAS DISLOCATED AND A CHIP WAS CONFIRMED TO HAVE COME OFF THE BIOLOX CERAMIC HEAD. WHILE WAITING FOR A REPLACEMENT HEAD FROM THE BRANCH, THE SURGEON DECIDED TO BROACH FOR A LARGER STEM (THERE ARE NO ALLEGATIONS AGAINST THE STEM). THE NEWLY IMPLANTED STEM, HEAD AND ADM/MDM INSERT WERE REMOVED AND IMPLANTED WITH A LARGER STEM, ANOTHER HEAD OF THE SAME CATALOG NUMBER, AND AN ADM/MDM INSERT OF THE SAME CATALOG NUMBER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN APPROXIMATELY 10-15 MINUTE DELAY OVERALL. REP PROVIDED AN IMPLANT SHEET AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8540528 ↗
• InjuryFeb 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POST-OPERATIVE DIAGNOSIS: PATIENT UNDERWENT PRIMARY RIGHT TOTAL HIP REPLACEMENT (B)(6) 2018. PATIENT RETURNED FOR INSTABILITY WITH TWO ANTERIOR DISLOCATIONS. PATIENT WAS REVISED ON (B)(6) 2018. ALL COMPONENTS EXCHANGED EXCEPT FEMUR.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8356615 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT HIP WAS REVISED. A RESTORATION MODULAR STEM CONSTRUCT WAS REVISED TO A LARGER CONSTRUCT, A CERAMIC HEAD WITH A SMALLER OFFSET, AND AN ADM POLY INSERT EXCHANGED FOR AN IDENTICAL IMPLANT.

  Patient problems: Injury

  MAUDE report 7789686 ↗