Biolox 6570-0-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04546540608475), received between Mar 1, 2017 and May 6, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 14, 2022Open, Classified

   Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

   Z-0842-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Degraded; Use of Device Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO ECCENTRIC POLY WEAR. INTRA-OPERATIVELY, IT WAS REPORTED THAT THE PATIENT HAD A 32MM CERAMIC FEMORAL HEAD INSIDE OF A 36D LINER, DESPITE THE USAGE FROM THE PRIOR PROCEDURE DOCUMENTING THAT A 36MM FEMORAL HEAD WAS IMPLANTED IN THE 36D LINER. THE HEAD AND LINER WERE REVISED TO A 36MM FEMORAL HEAD WITH A 36D LINER. HOSPITAL STAFF WANTS TO SPEAK TO SOMEONE AT STRYKER REGARDING THE FACT THAT A 32MM FEMORAL WAS IMPLANTED IN A 36D LINER AND SURGEON WANTS INVESTIGATION RESULTS. REP WILL PROVIDE ALL AVAILABLE DOCUMENTATION AND IMAGES AVAILABLE FROM THE HOSPITAL AND SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 25104146 ↗
• InjuryApr 24, 2026Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS PROVIDED: LEFT HIP REVISION. PT PRESENTED WITH A DISLOCATED HIP FOLLOWING A "COMPLEX" THA. DR. OPTED TO REVISE THE COMPETITOR LINER OPTION AND SWAP OUT OUR '32MM-4 HEAD' TO A '32MM+0 UNIVERSAL' OPTION. NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 24979779 ↗
• InjuryDec 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PATIENT WAS REVISED DUE TO REOCCURRING DISLOCATIONS. STEM WAS RETAINED. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY."

  Patient problems: Joint Dislocation

  MAUDE report 18263821 ↗
• InjuryMar 6, 2023Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  THE FOLLOWING WAS REPORTED: THE INCORRECT INNER HEAD WAS PLACED, WHICH WAS REVEALED IN THE POSTOPERATIVE X-RAYS. THE WOUND WAS IMMEDIATELY OPENED AND IT WAS REPLACED TO THE CORRECT INNER HEAD.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486441 ↗
• InjuryFeb 15, 2023Fracture; Fracture

  FEMORAL HEAD FRACTURE DUE TO FALL, REVISION SURGERY PLANNED.

  Patient problems: Fall

  MAUDE report 16383646 ↗
• MalfunctionJun 12, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT A SURGEON NOTICED THE ACTUAL IMPLANTED HEAD WAS NOT -4MM, IT WAS +4MM HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14672585 ↗
• MalfunctionMar 3, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT OUR CUSTOMER CHECKED X-RAY FOR PFA ((B)(4) , THE SURGEON SUSPECTED IT WAS +4MM/32MM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664366 ↗
• MalfunctionFeb 9, 2022Inaccurate Information; Inaccurate Information

  STRYKER REP REPORTED THE WRONG SIZE IMPLANT IN BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502023 ↗
• MalfunctionFeb 8, 2022Inaccurate Information; Inaccurate Information

  CUSTOMER REPORTED THAT IMPLANT LABELLED AS BIOLOX DELTA 32-4 BUT THE IMPLANT INSIDE WAS ACTUALLY 32+4. PRIMARY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13487149 ↗
• MalfunctionJan 27, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT DURING A THA, THE BOX LABEL WAS 6570-0-032 (-4MM) BUT THE CONTENT WAS A HEAD OF 6570-0-232 (+4MM). A METAL HEAD (32MM -4MM) WAS USED INSTEAD. ADDITIONAL INFORMATION: ACTUALLY, A SPARE DELTA HEAD (6570-0-032) WAS USED INSTEAD, NOT METAL HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13370164 ↗
• InjurySep 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IN REPORTING A REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2020, THE REP LEARNED THE PATIENT HAD A REVISION ON (B)(6) 2012 DUE TO INFECTION. THE FEMORAL HEAD ONLY WAS EXCHANGED. REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. THIS PI IS FOR THE (B)(6) 2012 REVISION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10533962 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2016 AND WAS REVISED ON (B)(6) 2016. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

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

  MAUDE report 9165803 ↗
• InjurySep 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PROCEDURE: I&D AND HEAD AND [COMPETITOR] LINER EXCHANGE. PRE-OP DIAGNOSIS: SEPTIC VS. ASEPTIC LOOSENING STATUS POST COMPLEX PRIMARY RIGHT TOTAL HIP. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL". A 32 -4 BIOLOX HEAD WAS REVISED TO A 32 BIOLOX HEAD WITH -2.5 SLEEVE. SPOKE TO REP. PATIENT WAS REVISED DUE TO INFECTION. REP PROVIDED PRE-REVISION X-RAYS AND A USAGE SHEET FROM THE PRIOR PROCEDURE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE 08 OCTOBER, 2019: REVIEW OF THE X-RAY BY A CLINICIAN CONFIRMS LOOSE CEMENTED STEM.

  Patient problems: Inadequate Osseointegration; Injury; Unspecified Infection

  MAUDE report 8977484 ↗
• InjuryJul 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S RIGHT HIP WAS REVISED. A 32MM -4 BIOLOX HEAD WAS REVISED TO A 36MM +0 BIOLOX HEAD.

  Patient problems: Injury

  MAUDE report 7655592 ↗
• MalfunctionApr 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE SCRUB NURSE REMOVED THE ITEM FROM THE PACKAGING INTO THE STERILIZE FIELD AND IT WAS REALIZED THAT THERE WAS HAIR WITHIN THE STERILE PACKAGING. A SECOND DEVICE WAS AVAILABLE WITHOUT DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7444520 ↗
• MalfunctionMar 1, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  THE CERAMIC HEAD BROKE SPONTANEOUSLY AFTER BEING PLACED ON THE STEM, EVEN BEFORE THE HIP WAS RESHAPED. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH REPLACEMENT OF THE BROKEN ITEM.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6369971 ↗