Biolox 6570-0-132Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04546540608505), received between Mar 15, 2018 and May 28, 2026 — classified as 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: "THE CERAMIC FEMORAL HEAD WAS IMPLANTED BY THE SURGICAL REG BY TAPPING WITH A REGULARLY USED HAMMER. WITH JUST ONE TAP, THE CERAMIC HEAD SHATTERED INTO MULTIPLE PIECES. BIOLOX DELTA HEAD APPLIED BY SURGICAL SPR USING CORRECT HAMMER AND IMPACTOR. SINGLE STRIKE AND HEAD SHATTERED. SWAB UNDER TRUNNION AND TRUNNION HAD BEEN CLEANED AFTER FINAL TRIAL- NO OBVIOUS TRUNNION DEFORMITY NOTED AT THAT STAGE SWAB APPEARED TO HAVE CAUGHT ALL THE FRAGMENTS. TRUNNION OF FEMORAL STEM SCORED". REMEDIAL ACTIONS TAKEN BY HEALTHCARE FACILITY: "INFORMED THE CONSULTANT, WHO THEN REMOVED THE SHATTERED PIECES AND THE STEM. A WASHOUT AND REPLACED WITH A NEW STEM AND CERAMIC HEAD".

  Patient problems: Insufficient Information

  MAUDE report 25315131 ↗
• InjuryJul 16, 2025Unstable; Unstable

  PATIENT'S RIGHT HIP REVISED DUE TO INSTABILITY. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. A 32 +0 BIOLOX HEAD WAS REVISED TO A 40MM UNIVERAL BIOLOX HEAD WITH +4 SLEEVE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22522927 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP: CHANGE OF FEMORAL HEAD DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20743930 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED THAT PATIENT REQUIRED A HIP REVISION FOR INFECTION. THE SAME PATIENT PREVIOUSLY HAD A CERAMIC V40 HEAD BUT THE SURGEON SPECIFIED THAT THE PATIENT ALREADY HAD THIS REPLACED WITH A METAL HEAD. SURGEON UNABLE TO GIVE FURTHER DETAILS.

  Patient problems: Unspecified Infection

  MAUDE report 16610848 ↗
• InjuryDec 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENTS SISTER LEFT VOICEMAIL ON PATIENT HOTLINE REPORTING THREE RIGHT HIP DISLOCATIONS OF TRIDENT COMPONENTS OVER A TWO MONTH PERIOD. PATIENTS SISTER IS ALSO INQUIRING ABOUT A PRODUCT RECALL. FEMORAL HEAD WAS THE ONLY COMPONENT PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 16021886 ↗
• InjuryDec 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "PT. PRESENTED WITH A DISLOCATED HIP, DR. OPTED TO SWAP OUT OUR FEMORAL HEAD WHILE ADDRESSING SOME ISSUES WITH COMPETITOR LINER. NO COMPLAINTS FILED AGAINST OUR COMPONENTS, NO FURTHER INFO AVAILABLE." SPOKE TO REP. A COMPETITOR CONSTRAINED LINER HAD DISSOCIATED OUT OF A COMPETITOR SHELL. THE LINER AND A STRYKER FEMORAL HEAD WERE REVISED. REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 15994280 ↗
• InjurySep 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED BY REP: "PT'S CHIEF COMPLAINT WAS HIP DISLOCATION FOLLOWING STRENUOUS ACTIVITY. DR. OPTED TO INCREASE HER OFFSET AND LEG LENGTH BY SWAPPING HER 32MM +0 FEMORAL HEAD TO A 32MM +4 HEAD. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES." REP CONFIRMED HEAD AND LINER DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 15451719 ↗
• InjuryNov 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PT REQUIRED THA REVISION FOR DISLOCATION. A CONSTRAINED LINER WAS IMPLANTED AND HEAD OFFSET WAS INCREASED BY 8MM.

  Patient problems: Insufficient Information

  MAUDE report 12766425 ↗
• InjuryMay 24, 2021Unstable; Unstable

  TOTAL HIP REV, FEMORAL HEAD LENGTHENING, CHANGED HEAD. UPDATE 28/APRIL/2021 WG: SPOKE TO REP. PATIENT'S HIP WAS REVISED DUE TO A PERCEIVED LIMB LENGTH DISCREPANCY. A 32 +0 BIOLOX HEAD WAS REVISED TO A 36MM HEAD AND SLEEVE, WHICH WAS THEN REVISED TO ANOTHER 32MM HEAD.

  Patient problems: Unequal Limb Length

  MAUDE report 11869327 ↗
• InjurySep 15, 2020Unstable; Unstable

  PATIENT COMPLAINED OF RIGHT HIP WEAKNESS AND FALL (X2) ON (B)(6) 2019. PATIENT STATED THAT THE FALL WAS DUE TO RIGHT HIP WEAKNESS. RADIOGRAPHIC NOTES INDICATES NO LOOSENING, FRACTURE OR SUBSIDENCE. PATIENT NOT REVISED AS OF (B)(6) 2019.

  Patient problems: Insufficient Information

  MAUDE report 10534009 ↗
• InjuryMay 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BOOKED REVISION CASE DUE TO DISLOCATION POST PREVIOUS FRACTURE. HEAD AND LINER REVISED FROM +0 HEAD TO +8 HEAD AND MDM. MDM TRIALED ON TABLE AND CASE COMPLETED. THIS PI IS FOR THE DISLOCATION. UPDATE: 02 APRIL 2019: THIS PATIENT HAS HAD MULTIPLE CLOSED REDUCTIONS FOR DISLOCATION. THESE DISLOCATIONS ARE COVERED UNDER (B)(4). THIS REVISION WAS DUE TO THE RECURRENT DISLOCATIONS HOWEVER THE PATIENTS HIP WAS NOT DISLOCATED AT THE TIME OF REVISION SURGERY. MEDICAL REVIEW HAS IDENTIFIED INCORRECT USE OF 10DEGREE LINER AND CERAMIC HEAD (32/0) LEADING TO LIMB LENGTH DISCREPANCY AND RECURRENT DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8568771 ↗
• InjuryDec 26, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS PER RECEIVED MEDICAL RECORDS: PATIENT WAS REVISED DUE TO DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8198193 ↗
• InjurySep 10, 2018Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT HIP WAS REVISED. PATIENT ORIGINALLY HAD AN ENTIRE STRYKER HIP CONSTRUCT INCLUDING A 32 +0 CERAMIC HEAD IMPLANTED IN (B)(6) 2017. REVISION IMPLANT SHEET ONLY INDICATES A 32 +4 CERAMIC HEAD WAS IMPLANTED. UPDATE (B)(6) 2018: SALES REP STATED "THE PATIENT HAD FALLEN FROM A LADDER AND DISLOCATED. SHE TOLD THE SURGEON THAT SHE CONTINUED TO DISLOCATE AFTER BEING POPPED BACK IN MULTIPLE TIMES. THE SURGEON DECIDED TO REVISE THE POLY/HEAD TO FIX THE ISSUE. AFTER BEGINNING THE PATIENT, IT APPEARED DIFFICULT TO DISLOCATE HER. WE TRIALED A +4 HEAD AND SHE APPEARED EXTREMELY STABLE SO HE JUST CHANGED OUT THE HEAD. NO FAULT OF STRYKER PRODUCTS AT ALL, PURELY AN ACCIDENT FROM THE PATIENT FALLING OFF A LADDER."

  Patient problems: Fall; Injury; Joint Dislocation

  MAUDE report 7861730 ↗
• MalfunctionApr 19, 2018Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  THE CUSTOMER POSTED A NOTICE ON THEIR 'BULLETIN NOTICE BOARD' THAT THE BIOLOX DELTA CERAMIC HEAD HAD A FOREIGN BODY / BLACK SPECK ON THE FOAMY PACKAGING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7444516 ↗
• MalfunctionMar 15, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT IN PERFORMING A PRIMARY HIP (SIDE NOT REPORTED) PROCEDURE, THE 32MM +0 HEAD WOULD NOT LOCK ONTO THE ACCOLADE II STEM. THE HEAD WAS ABLE TO BE MANUALLY REMOVED BY THE SURGEON. ANOTHER HEAD WAS IMMEDIATELY AVAILABLE AND LOCKED ONTO THE STEM WITH NO ISSUES. REP REPORTED THAT NO CASE TIME WAS LOST (NO SURGICAL DELAY).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7342834 ↗