Biolox 6570-0-436Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540608567), received between Jan 17, 2017 and Apr 2, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryApr 2, 2026Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A STRYKER HIP (RIGHT). THIS COMPONENT IS BEING REVISED DUE TO 3 DISLOCATIONS. NO VISIBLE SIGNS OF DAMAGE NOR WEAR TO THE HEAD, POLY AND TRUNNION. HE REPLACED THE HEAD WITH A 6260-9-236 (LFIT 36 +5). THE LINER WAS NOT REMOVED AND STAYED WITHIN THE PATIENT. THE SURGEON DID NOT WANT TO REMOVE.

  Patient problems: Joint Dislocation

  MAUDE report 24765551 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A LEFT HIP REVISION DUE TO POST OPERATIVE DISCOMFORT. INVESTIGATIVE REVISION PERFORMED TO DETERMINE INFECTION, NO ACTIVE INFECTION DURING THIS PROCESS, DETERMINED REASON FOR REVISION WAS METALLOSIS.

  Patient problems: Discomfort; Foreign Body Reaction

  MAUDE report 17649299 ↗
• InjuryMay 3, 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 PAIN. AN UNKNOWN LINER AND 36 MM BIOLOX HEAD WERE REVISED TO A 10° LINER WITH ADAPTER SLEEVE AND A NEW HEAD. REP CONFIRMED THAT ASIDE FROM PRIMARY AND REVISION USAGE SHEETS, NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE - (B)(6) 2021 - BP: A 36E 0° TRIDENT X3 POLY INSERT AND 36 -2.5MM BIOLOX DELTA CERAMIC V40 HEAD WERE REVISED TO A 36E 10° TRIDENT X3 POLY INSERT AND 36 +7.5MM BIOLOX CERAMIC C-TAPER HEAD WITH ADAPTER SLEEVE.

  Patient problems: Pain

  MAUDE report 11764764 ↗
• InjuryNov 26, 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. PRIMARY AND REVISION IMPLANT SHEETS INDICATE THAT A 36 -2.5 BIOLOX HEAD WAS REVISED TO A 36 +7.5 BIOLOX HEAD.

  Patient problems: Injury

  MAUDE report 8104393 ↗
• MalfunctionJun 19, 2018Difficult to Insert; Difficult to Insert

  AN EXETER STEM WAS IMPLANTED IN A PATIENT AS PART OF A PRIMARY TOTAL HIP ARTHROPLASTY. A 36MM V40 CERAMIC HEAD (-2.5) WAS OPENED AND PLACED ON THE TRUNNION. WHEN THE SURGEON USED A HEAD PUSHER AND MALLET TO IMPACT THIS, IT SOUNDED LIKE IT BOTTOMED OUT WITHOUT GRIPPING TO THE TRUNNION. THE SURGEON WAS STILL ABLE TO PULL THE HEAD OFF THE TRUNNION EVEN AFTER IMPACTING IT. THE SURGEON TRIED AGAIN FOUR MORE TIMES, EACH TIME HITTING THE HEAD PUSHER HARDER AND MORE TIMES WITH THE MALLET YET AFTER EACH ATTEMPT, THE HEAD COULD THEN STILL BE PULLED STRAIGHT OFF THE TRUNNION BY HAND. THIS WAS EVENTUALLY DISCARDED AND A NEW HEAD WAS IMPACTED ON THE TRUNNION. THE SURGEON REPORTED THAT THE TRUNNION WAS CLEAN AND HAD NO MARKINGS THAT HE COULD SEE. THE INNER ASPECT OF THE HEAD ALSO APPEARED CLEAN AND FREE OF DEBRIS. THE ISSUE WAS NOTICED BY OBSERVATION FROM ALL STAFF IN THE THEATRE WITNESSING THE HEAD BEING REPEATEDLY IMPACTED BUT NOT ACTUALLY GRIPPING TO THE TRUNNION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7615747 ↗
• InjuryMay 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A PRIMARY LEFT HIP IMPLANT ON (B)(6) 2018, PATIENT EXPERIENCED FOOT DROP. ON REVISION (B)(6) 2018, SURGEON REPORTED THE PATIENT'S NERVE WAS OK BUT NOTED SLIGHT HEMATOMA. THE FEMORAL HEAD WAS REVISED. REP REPORTED THAT PRIOR TO HIP REPLACEMENT, PATIENT SUFFERED A STIFF HIP. AFTER REPLACEMENT, PATIENT WAS UNACCUSTOMED TO THE NEWFOUND FREEDOM OF MOVEMENT AND AS A RESULT, THE NERVE STRETCHED OUT. PATIENT SUFFERED FROM NERVE PALSY, LIKELY STEMMING FROM A SPINAL PROBLEM. THE NERVE WAS EXPLORED WITH NO IMPINGEMENT NOTED.

  Patient problems: Nerve Damage; Peroneal Nerve Palsy

  MAUDE report 7548747 ↗
• InjuryMay 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED LEFT HIP REVISION STATING LINER WASN'T SEATED, AND LEG LENGTH DISCREPANCY PRESENT. LINER WAS REMOVED AND REPLACED, SHORTER HEAD/NECK WAS ALSO REPLACED.

  Patient problems: Injury

  MAUDE report 6603190 ↗
• MalfunctionMay 30, 2017Inadequacy of Device Shape and/or Size; Fitting Problem; Malposition of Device; Inadequacy of Device Shape and/or Size; Fitting Problem

  THE 36MM -2.5 BIOLOX CERAMIC HEAD V40 TAPER DIDN'T SUCCESSFULLY SIT ONTO ACCOLADE II V40 TRUNNION. SURGEON UNSURE IF SOFT TISSUE IMPINGEMENT CAUSED THE HEAD TO NOT SIT PROPERLY, HOWEVER DECIDED TO OPEN AND USE A DIFFERENT FEMORAL HEAD. HOSPITAL STAFF DISCARDED OF IMPLANT PER HOSPITAL PROTOCOL.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6597507 ↗
• MalfunctionJan 17, 2017Adverse Event Without Identified Device or Use Problem; Packaging Problem; Adverse Event Without Identified Device or Use Problem

  REP REPORTED RECEIVING THE DEVICE THAT DID NOT MATCH THE LABEL ON THE BOX. REP RECEIVED A C TAPER UNIVERSAL CERAMIC FEMORAL HEAD VS CERAMIC V40 HEAD. PER INVESTIGATOR, UPDATE FROM SALES REP INDICATED THAT THIS EVENT WAS RELATED TO AN ASSEMBLY ISSUE BETWEEN THE HEAD AND THE STEM.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6256091 ↗