Biolox 6570-0-736Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04546540608581), received between May 8, 2017 and Jun 15, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO CRACK/FRACTURE OF THE CERAMIC FEMORAL HEAD. PATIENT DENIES ANY TRAUMA. INTRA-OPERATIVELY, THE FOLLOWING WAS OBSERVED: THE CERAMIC FEMORAL HEAD WAS BROKEN INTO SEVERAL PIECES. AS A RESULT, THE TRUNNION OF THE STEM GOUGED INTO THE LINER. THE HEAD AND LINER WERE REVISED TO A METAL HEAD AND POLY LINER. REP CONFIRMED THAT SOME ADDITIONAL INFORMATION MAY BE ABLE TO BE PROVIDED. SURGEON WOULD LIKE THE INVESTIGATION RESULTS.

  Patient problems: Insufficient Information

  MAUDE report 25511244 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REFERRED BY A GENERAL PRACTITIONER DUE TO ACUTE PAIN IN THE LEFT HIP AND A HISTORY OF LEFT HIP REPLACEMENT 6 YEARS AGO. MILD PAIN IN THE LEFT HIP SINCE THE PREVIOUS DAY; SUBSEQUENTLY, SEVERE PAIN AND A ¿CRACKING¿ SENSATION IN THE LEFT HIP, TO THE POINT THAT SHE COULD NO LONGER BEAR WEIGHT ON HER LEFT LOWER EXTREMITY. UPON QUESTIONING, THE PATIENT REPORTED HAVING HAD RECURRING PAIN AND ALSO SCIATIC SYMPTOMS.

  Patient problems: Insufficient Information

  MAUDE report 24953792 ↗
• InjuryNov 26, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 23657487 ↗
• InjuryAug 13, 2025Fracture; Fracture

  LEFT THR DONE IN 2021. PATIENT PRESENTED TO EMERGENCY DEPARTMENT AFTER RECENT FALL FROM BICYCLE. CERAMIC FEMORAL HEAD DISLODGED FROM FEMORAL STEM. REVISION HIP SURGERY REQUIRED TO REMOVE FRACTURED CERAMIC FEMORAL HEAD AND REPLACE HEAD, STEM AND ACETABULAR INSERT.

  Patient problems: Ambulation or Postural Difficulties; Fall

  MAUDE report 22795557 ↗
• InjuryMay 19, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THE PATIENT WAS RELATIVELY HIGH IN ACTIVITY THE WEEK OF THE INCIDENT PER SURGEON. PATIENT HEARD A POP ON MONDAY ON (B)(6). THEN, PER SURGEON, THE PATIENT WAS STANDING UP FROM THE TOILET AND HEARD A SECOND POP ON THE DATE ON (B)(6). THE PATIENT THEN PRESENTED TO THE ED WITH THE FEMORAL HEAD DISASSOCIATED FROM THE FEMORAL STEM ON THE DATE ON (B)(6). (ON XRAY FRACTURE OF THE CERAMIC FEMORAL HEAD WAS NOT EVIDENT). THE REVISION SURGERY TOOK PLACE ON THE FOLLOWING DAY, ON (B)(6) 2025. IN THE REVISION SURGERY, THE CERAMIC FEMORAL HEAD WAS FOUND TO BE FRACTURED INTO 2 LARGE FRAGMENTS AND MANY SMALLER FRAGMENTS. THE 2 LARGE FRAGMENTS WERE CAUSED BY A MIDLINE SPLIT OF THE FEMORAL HEAD. THE TRUNNION OF THE FEMORAL STEM WAS IN RELATIVELY DECENT SHAPE, PER SURGEON. THE FEMORAL HEAD AND ACETABULAR INSERT WERE THEN REVISED TO A 40 UNIVERSAL FEMORAL HEAD WITH A +4 V40 TAPER SLEEVE AND 40E ACETABULAR INSERT.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 22048659 ↗
• InjuryMay 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. DUE TO THE CERAMIC HEAD FRACTURING IN HALF, THE HEAD DISSOCIATED FROM THE STEM. THE HEAD AND LINER WERE REVISED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22012505 ↗
• InjuryNov 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE HEAD BREAKING INTO SEVERAL PIECES. ALL IMPLANTS WERE REMOVED. REP DOES NOT HAVE ANY ADDITIONAL INFORMATION AT THE TIME OF REPORT. UPDATE: THE CUP WAS NOT REVISED. THE LINER WAS REPLACED. THE STEM WAS REPLACED DUE TO THE TRUNNION BEING DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 20634390 ↗
• InjuryJun 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. INTRA-OPERATIVELY, THE FOLLOWING WAS NOTED: THE CERAMIC HEAD WAS BROKEN INTO AT LEAST 2 PIECES. THE INSIDE OF THE HEAD SHOWED CONCENTRIC WEAR, AND THE TRUNNION WAS DAMAGED. REVISING SURGEON REPORTED HIS ASSESSMENT: THE SURGEON FOR THE INDEX PROCEDURE (DIFFERENT SURGEON) WASTED A -5 CERAMIC HEAD, AND IMPLANTED A +7.5 CERAMIC HEAD WITHOUT A SLEEVE. REVISING SURGEON BELIEVES THE HEAD WAS NOT FULLY IMPACTED ON THE STEM, LEADING TO MOTION OF THE HEAD ON THE STEM. THE CERAMIC HEAD AND NEUTRAL POLY LINER WERE REVISED TO ANOTHER CERAMIC HEAD AND NEUTRAL ECENTRIC POLY LINER (REASON FOR THE LINER CHANGE WAS THE SURGEON WANTED TO TIGHTEN UP THE CONSTRUCT AND DID NOT WANT TO USE A +7.5 OR +10 HEAD).

  Patient problems: Pain

  MAUDE report 19517455 ↗
• InjuryDec 14, 2023Fracture; Fracture

  BIOLOX V40 PLUS 7.5 HEAD FRACTURED IN HALF. ORIGINAL PRIMARY HIP WAS DONE ON 2/14/23. REVISION PERFORMED.

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

  MAUDE report 18326364 ↗
• InjuryApr 6, 2023Corroded; Corroded

  REP REPORTED THE PATIENT'S LEFT HIP IMPLANTED ON (B)(6) 2011 WAS REVISED ON (B)(6) 2023. INITIAL PATIENT COMPLAINTS WERE PAIN, ELEVATED ION LEVELS, AND MEMORY LOSS. INTRA-OPERATIVELY, CORROSION WAS NOTED AT THE STEM/ NECK INTERFACE AND AT THE INTERFACE OF THE TRUNNION AND CERAMIC HEAD. THE STEM CONSTRUCT, HEAD, AND LINER WERE REVISED.

  Patient problems: Memory Loss/Impairment; Metal Related Pathology; Pain

  MAUDE report 16697182 ↗
• InjuryFeb 24, 2021Fracture; Fracture

  AS REPORTED: "PERFORMED A LEFT (MAKO) HIP REVISION DUE TO CERAMIC HEAD FRACTURE AND GROSS TRUNNION FAILURE. ORIGINAL TRIDENT 2 CUP STAYED. NO MORE INFORMATION IS AVAILABLE PER DOCTOR AND IMPLANTS WILL NOT BE RETURNED DUE TO HOSPITAL POLICY." SPOKE TO REP. THE CERAMIC HEAD CRACKED IN HALF. INTRAOPERATIVELY, WEAR AND GROOVING OF THE TRUNNION OF THE STEM WAS NOTED. IT IS NOT KNOWN IF EITHER DEVICE FAILURE WAS THE CAUSE OF THE OTHER. A STEM, HEAD AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Insufficient Information

  MAUDE report 11371835 ↗
• MalfunctionJan 13, 2021Noise, Audible; Noise, Audible

  AS REPORTED: "UPON STUDY MONITOR REVIEW, (B)(6) 2020 CLINIC NOTES INDICATE THE SUBJECT NOTICES "PAINLESS CLUNKING SOUND AT RIGHT HIP WITH EXERCISE, WHICH SHE HAS HAD SINCE AT LEAST (B)(6) 2020." SUBJECT IS OTHERWISE DOING FINE, REPORTING NO PAIN, NO LIMITS TO ACTIONS OF DAILY LIFE. PER THE STUDY MONITOR THE "CLUNKING" WAS NOT ADDRESSED FURTHER/DID NOT REQUIRE TREATMENT".

  Patient problems: No Information

  MAUDE report 11161997 ↗
• InjuryJan 4, 2021Unstable; Unstable

  PROCEDURE: THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY (B)(6) 2019. PATIENT UNDERWENT REVISION LEFT TOTAL HIP ARTHROPLASTY ON THE LEFT SIDE, BOTH COMPONENTS CHANGED FOR CLOSURE OF DEHISCED LEFT HIP SURGICAL WOUND ON (B)(6) 2020. THE PATIENT WAS HAVING INSTABILITY SO UNDERWENT A SECOND REVISION ON (B)(6) 2020. ONLY THE LINER AND THE HEAD WERE EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 11107244 ↗
• InjuryAug 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY (B)(6) 2019. PATIENT UNDERWENT REVISION LEFT TOTAL HIP ARTHROPLASTY ON THE LEFT SIDE, BOTH COMPONENTS CHANGED FOR CLOSURE OF DEHISCED LEFT HIP SURGICAL WOUND (B)(6) 2020.

  Patient problems: Injury; Wound Dehiscence

  MAUDE report 10458028 ↗
• InjuryApr 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE DOCTOR BROUGHT THE PATIENT BACK FOR DISLOCATION. REMOVED HEAD AND LINER. WENT TO A LARGER HEAD WITH LONGER NECK LENGTH.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9954279 ↗
• InjurySep 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PATIENT WAS IMPLANTED ON (B)(6) 2017 WITH A STRYKER RESTORATION MODULAR; A COMPETITOR'S CUP WAS RETAINED, LINER REPLACED. SINCE THEN, THE PATIENT HAS DISLOCATED ANTERIORLY TWICE SO DOCTOR REVISED TODAY. A DIFFERENT LINER WAS INSERTED INTO THE COMPETITOR'S CUP, AND THE RESTRAINED PIECE WAS EXTRACTED. THE TRIAL WAS DEANTEVERTED, STABILITY ACHIEVED. A NEW BODY TRIAL WAS INSERTED AND A LONGER HEAD. NOTHING WAS LOOSE OR BROKEN.

  Patient problems: Injury

  MAUDE report 6856005 ↗
• InjuryMay 8, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SALES REP REPORTED, A LEFT HIP REVISION. THE FEMORAL HEAD DISASSOCIATED FROM THE STEM. X-RAY SHOWED HEAD CAME OFF THE STEM.

  Patient problems: Injury

  MAUDE report 6552314 ↗