Biolox 6570-0-236Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04546540608543), received between Nov 7, 2017 and Aug 22, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025Fracture; Fracture

  RIGHT HIP REVISION HEAD AND LINER EXCHANGE OF A BROKEN BIOLOX HEAD. NO MORE INFORMATION IS AVAILABLE PER SURGEON AND IMPLANT IS NOT AVAILABLE FOR RETURN PER HOSPITAL RULES.

  Patient problems: Insufficient Information

  MAUDE report 22874713 ↗
• InjuryMay 29, 2025Fracture; Fracture

  THE FEMORAL HEAD SPLIT WHILE INSIDE OF A PATIENT. REVISION WAS SUCCESSFUL AND COMPLETED TO MY KNOWLEDGE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 22105649 ↗
• InjuryFeb 23, 2025Degraded; Fracture; Degraded; Fracture

  AS REPORTED: "A PATIENT THAT HAD A LEFT PRIMARY DIRECT ANTERIOR HIP REPLACEMENT ON (B)(6) 2023. OVER 15 MONTHS LATER HE REPORTED PAIN AND LIMITED RANGE OF MOTION AND SUBSEQUENTLY FOLLOWED UP WITH DR., DR. SAW ON X-RAY THAT THERE WERE WHAT LOOKED TO BE FRACTURED PIECES OF THE PATIENTS BIOLOX DELTA V40 FEMORAL HEAD. THE PATIENT WAS THEN BROUGHT TO SURGERY FOR A HEAD AND LINER EXCHANGE REVISION SURGERY. INTRAOPERATIVELY: THE SURGEON NOTICED FRAGMENTED PIECES OF THE BIOLOX DELTA V40 AND THE FEMORAL HEAD WAS SPLIT IN HALF. THERE WERE SOME DARK STAINING OF THE SOFT TISSUES AND A SLIGHT METALLOSIS APPEARANCE. THE SURGEON REMOVED THE FEMORAL HEAD, REMAINING CERAMIC PIECES IN THE JOINT, AS WELL AS THE LINER, THE STEM AND CUP WERE WELL FIXED, NOT DAMAGED, AND THEN RETAINED. THE SURGEON THEN PUT A V40 TO C- TAPER ADAPTOR SLEEVE ON AND A NEW BIOLOX C-TAPER FEMORAL HEAD." REP REPORTED THAT THE (CONSULTANT) SURGEON WOULD LIKE INVESTIGATION RESULTS, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Loss of Range of Motion; Pain

  MAUDE report 21442539 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REP LEFT A VOICEMAIL REPORTING PATIENT'S HIP WAS REVISED DUE TO FAILURE OF A CERAMIC HEAD. REP WENT ON TO REPORT EVERY IMPLANT IN SITU.

  Patient problems: Insufficient Information

  MAUDE report 17291760 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED A PRIMARY STRYKER THA WAS IMPLANTED IN HER LEFT HIP (B)(6) 2022. 1 DAY POST-OP, PATIENT NOTICED A LIMB LENGTH DISCREPANCY OF APPROXIMATELY AN ADDITIONAL .75" ON HER OPERATIVE SIDE (PATIENT IS 65" STANDING ON HER RIGHT FOOT, 65.75" STANDING ON HER LEFT FOOT). INDEX SURGEON PROPOSED TO IMPLANT A THA ON THE CONTRALATERAL SIDE TO MATCH LIMB LENGTHS. AFTER SEEKING A SECOND OPINION, A REVISION OF THE HIP IS SCHEDULED (B)(6) 2022. REVISING SURGEON REPORTED TO THE PATIENT THAT THE IMPLANTS WERE TOO LARGE FOR THE PATIENT'S ANATOMY. PATIENT IS INQUIRING IF THERE HAVE BEEN OTHER REPORTS OF LIMB LENGTH DISCREPANCY REPORTED WITH THE INDEX SURGEON OR WITH HER IMPLANTS. UPDATE 1: CLARIFICATION FROM PATIENT: "I¿M NOT SURE HE [REVISING SURGEON] ACTUALLY SAID IT WAS TOO BIG FOR MY ANATOMY, MORE THAT THE ANGLE WAS WRONG. WE DIDN¿T REALLY UNDERSTAND. ON MY LAST POST OP VISIT WITH THE ORIGINAL DOCTOR HE CHANGED HIS PLAN FROM DOING MY RIGHT HIP TO HAVING PELVIC OBLIQUITY PHYSICAL THERAPY FOR MY LEFT AND GETTING A SPECIAL SHOE MADE." UPDATE 2: REVISION WAS DUE TO LEG LENGTH DISCREPANCY AND GAIT. REVISION HIP IS "DOING WELL".

  Patient problems: Unequal Limb Length

  MAUDE report 16898776 ↗
• InjuryFeb 7, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO LIMB LENGTH DISCREPANCY APPROXIMATELY 1 INCH. A 36 +5 BIOLOX HEAD WAS REVISED TO A 36 +10 LFIT HEAD.

  Patient problems: Unequal Limb Length

  MAUDE report 16309995 ↗
• InjuryNov 15, 2022Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. PATIENT REPORTED HEARING A POP IN HIS HIP AND AFTERWARDS, THE HIP STARTED SQUEAKING. IT WAS DETERMINED THAT THE LINER DISSOCIATED FROM THE SHELL, ALLOWING THE FEMORAL HEAD TO RUB INSIDE THE SHELL. INTRA-OPERATIVELY, THE SURGEON COULD NOT DETERMINE WITH CERTAINTY IF ONE OF THE SCREWS WAS PROUD BUT COULD NEITHER LOOSEN NOR TIGHTEN IT AS IT WAS STRIPPED, SO THE SURGEON BURRED THE HEAD DOWN TO BE CERTAIN. THE HEAD AND THE LINER WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15797096 ↗
• InjuryJul 13, 2022Degraded; Degraded

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. PER SALES REP: "PATIENT HAD A PERIPROSTHETIC FRACTURE. STEM WAS REVISED AND REPLACED WITH A LONGER MONOLITHIC STEM. SHELL STAYED INTACT AND LINER WAS REVISED TO AN MDM." COMPARING RECORDS FROM PATIENT'S PRIOR REVISION INDICATE THAT A SIZE 7 ANATO STEM, 36 +5 BIOLOX HEAD, AND 36F 0° LINER WERE REVISED. UPDATE: "THERE WAS A FRACTURE LATERALLY AND SLIGHTLY DISTAL FROM THE GREATER TROCH. MINOR WEAR ON THE LINER AND HEAD WAS OBSERVED.

  Patient problems: Bone Fracture(s)

  MAUDE report 15008463 ↗
• InjuryFeb 25, 2021Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  2014 RIGHT HIP REPLACEMENT WITH STRYKER. 2017 LEFT HIP REPLACEMENT WITH STRYKER. UPDATE: AS PER PATIENT, SHE HAD A RIGHT THA DONE (B)(6) 2013 ABOUT FOUR MONTHS AFTER SURGERY SHE COULDN'T WALK DURING PT, SHE STARTED TO EXPERIENCE PAIN, HAS NO BALANCE. PATIENT HAS TO USE A WALKER. PATIENT WOULD LIKE TO KNOW IF HER IMPLANTS ARE PART OF A RECALL. PATIENT IS SEEKING ASSISTANCE WITH REVISION SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Anemia; Depression; Joint Laxity; Pain

  MAUDE report 11378367 ↗
• InjuryJan 12, 2021Fracture; Fracture

  AS REPORTED: "PATIENT REPORTED GETTING HIS FOOT STUCK IN A RECLINER AND HEARING A 'POP' AND HIP WENT LIMP/FLACCID. X-RAYS APPEARED TO SHOW A BROKEN HEAD. PATIENT WAS BROUGHT TO OR FOR REVISION OF HEAD AND LINER. V-40 BIOLOX 36 MM +5 MM HEAD WAS FOUND TO BE BROKEN. A UNIVERSAL V40 TAPER ADAPTER SLEEVE +4 AND 36 MM UNIVERSAL HEAD WERE PUT ON IN ADDITIONAL TO A NEW LINER, AFTER HIP WAS DEBRIDED EXTENSIVELY." SPOKE TO REP: SHELL AND LINER WERE COMPETITOR DEVICES.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11153266 ↗
• InjuryAug 4, 2020Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY AND DISLOCATION OF THE HEAD FROM THE POLY LINER. THE SHELL WAS REVISED DUE TO THE SURGEON NEEDING MORE ANTEVERSION. PATIENT WAS REVISED TO A 28MM + 12 MM L FIT V40 FEMORAL HEAD, A 28/52 MM RESTORATION ADM/MDM X3 INSERT, A 46 MM MDM CEMENTLESS LINER, AND 56 MM TRIDENT II CLUSTERHOLE HA SHELL WITH THREE 6.5MM X 15 MM SCREWS AND ONW 6.5 MM X 20 MM SCREW. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10364864 ↗
• InjuryJun 25, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY. SURGEON REPORTED HIS SUSPICION THAT THE PROXIMAL CONE BODY WAS PROBABLY NOT FULLY SEATED DURING THE PRIMARY IMPLANTATION. THE PROXIMAL CONE BODY, BIOLOX CERAMIC HEAD, AND 36D 0° INSERT WERE REVISED TO A PROXIMAL CONE BODY, LFIT V40 HEAD, SIZE D CONSTRAINED INSERT, AND A DALL-MILES GRIP PLATE WITH CABLES. REP PROVIDED USAGE SHEETS FOR THE PRIMARY AND REVISION SURGERIES, PICTURES OF THE EXPLANTS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10194102 ↗
• InjuryJan 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S RIGHT KNEE WAS REVISED. A NOTE AT THE BOTTOM OF THE SHEET REPORTS "REVISED FOR INSTABILITY AND POSSIBLE INFECTION". AN MRH KNEE CONSTRUCT WAS REVISED TO AN MRH/ GMRS KNEE CONSTRUCT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9628289 ↗
• InjuryDec 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT HAD PRIMARY RIGHT TOTAL HIP COMPLETED ON (B)(6) 2019. PATIENT FELL AND HEARD POP WHILE GOING TO THE BATHROOM ON (B)(6) 2019 [EXAM NOTE AND OPERATIVE REPORT STATE "PATIENT GOT UP TO GO TO THE BATHROOM WITH HIS WALKER, LOST BALANCE AND FELL, LANDING HARD ON HIS KNEE, 'BENDING LIKE AN ACCORDION' WITH RIGHT KNEE BENT SUDDENLY TO CHEST. IMMEDIATE ONSET OF SEVERE SHARP RIGHT HIP AND GROIN PAIN, RADIATING DOWN RIGHT LEG, WORSE WITH TOUCH OR MOVE, NO ALLEVIATING FACTORS"]. PATIENT BOOKED FOR SURGERY ON (B)(6) 2019 - PERIPROSTHETIC FEMUR FRACTURE. DOCTOR REMOVED THE FEMORAL STEM AND HEAD BY HAND - HE NOTED THAT HE WAS ABLE TO SEPARATE THE HEAD FROM THE STEM BY HAND. HE ASKED POST-SURGERY TO HAVE STRYKER LOOK AT THIS CERAMIC HEAD. HE WAS UNSURE WHY IT CAME APART BY HAND. HE REDUCED THE FRACTURE AND PLACED 3 CABLES. HE RE-INSERTED THE ORIGINAL STEM BACK TO ITS ORIGINAL PLACEMENT. HE TRIALED A 36 +5 TRIAL HEAD AND FOUND IT TO BE ADEQUATE. A 36 +5 COCR HEAD WAS IMPACTED ON. A HISTORY AND PHYSICAL AND POST-OPERATIVE REPORT WILL FOLLOW. THE BIOLOX EXPLANT HEAD WILL BE SENT BACK AND NO FURTHER INFORMATION WILL BE AVAILABLE."

  Patient problems: Bone Fracture(s); Fall; Injury; Pain

  MAUDE report 9433524 ↗
• InjurySep 24, 2019Fracture; Fracture

  PATIENT HAD A 3 FOOT FALL. CERAMIC HEAD WAS SMASHED IN PIECES AND REQUIRED A NEW FEMORAL HEAD WITH DUAL MOBILITY.

  Patient problems: Injury

  MAUDE report 9109106 ↗
• InjuryMay 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A BROKEN CERAMIC FEMORAL HEAD. NO CAUSE OR CONTRIBUTOR WAS REPORTED BY THE SURGEON, BUT PATIENT USE OF AN ELLIPTICAL WAS MENTIONED. THE CERAMIC HEAD AND LINER WERE REVISED. REP CONFIRMED THAT THERE WAS NO DAMAGE TO AND NO ALLEGATIONS AGAINST THE LINER. REP PROVIDED PRE-REVISION X-RAYS AND A PICTURE OF THE EXPLANTED HEAD.

  Patient problems: Injury

  MAUDE report 8582715 ↗
• InjuryJan 23, 2019Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "LEFT HIP [REVISION] - THIGH PAIN, LOOSE PROSTHESIS PROBABLE". A 36 0° X3 INSERT, 50 MM TITANIUM SHELL, 36 +5 BIOLOX V40 HEAD, AND ACCOLADE II #3 132° WERE REVISED TO COMPETITOR DEVICES.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8270761 ↗
• MalfunctionNov 7, 2017Crack; Material Discolored; Crack; Material Discolored

  IT WAS REPORTED THAT DURING A PRIMARY IMPLANT OF PATIENT'S RIGHT HIP, SURGEON IMPLANTED A BIOLOX HEAD WHEREUPON THE PA NOTICED BLACK LINES AROUND THE RIM OF THE HEAD. SURGEON COULD NOT DETERMINE IF THE MARKS WERE CRACKS OR FRICTION MARKS AND ELECTED TO NOT USE THE IMPLANT. THE HEAD WAS REMOVED AND ANOTHER HEAD, WHICH WAS IMMEDIATELY AVAILABLE FROM A LOANER KIT, WAS IMPLANTED INSTEAD. REP REPORTED THAT THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7006536 ↗