Biolox 6570-0-136Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04546540608512), received between Jun 26, 2017 and May 27, 2026 — classified as 21 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Noise, Audible

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SQUEAKING. THE HIP CONSTRUCT HAD A POLY LINER WITH A CERAMIC HEAD, BUT THE SURGEON SUSPECTS THAT THERE IS A POSSIBLE UNSPECIFIED ISSUE INSIDE THE HEAD. THE HEAD AND LINER WERE REVISED TO A NEW POLY LINER WITH METAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 25304283 ↗
• InjuryOct 20, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  NO NEW INFORMATION

  Patient problems: Joint Dislocation

  MAUDE report 23334793 ↗
• InjurySep 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT FELL AND DISLOCATED HIS TOTAL HIP 3 HOURS AFTER THE INITIAL SURGERY. THE SURGEON ATTEMPTED TO CLOSE REDUCE THE HIP, BUT IT WAS NOT POSSIBLE. THE PATIENT WAS TRANSFERRED TO A NEAR BY HOSPITAL WHERE AN OPEN REDUCTION REVISION SURGERY WAS PERFORMED. THE SURGEON WAS ABLE TO OPEN REDUCE THE HIP AND CHOSE TO BE LENGTHENING THE HIP BY UTILIZING A +2.5 HEAD.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23022441 ↗
• InjuryAug 19, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  REVISION OF A TOTAL HIP. USED A 36 + 7.5 CERAMIC HEAD ON AN EXISTING 35.5 STEM. MAXIMUM OFFSET FOR ON LABEL USE ON A 35.5 IS A +4. THE CERAMIC HEAD WAS ALSO USED WITHOUT A SLEEVE AND PUT ON AN OLD TRUNNION. ORIGINAL SURGERY WAS DONE SOMETIME IN (B)(6) 2024. NO PATIENT CONSEQUENCE. OFF LABEL USAGE OF IMPLANTS. REASON FOR REVISION: UNSURE. I BELIEVE IT WAS BECAUSE THE PATIENT REQUIRED MORE LEG LENGTH.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 22842701 ↗
• InjuryNov 7, 2024Use of Device Problem; Use of Device Problem

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT A 36MM BIOLOX HEAD WAS IMPLANTED WITH A 32D 10° LINER. DISCOVERY WAS MADE WHEN PATIENT WAS IN THE RECOVERY ROOM. PATIENT WAS BROUGHT BACK TO THE OR AND THE FEMORAL HEAD WAS REVISED TO A 32MM HEAD AND SLEEVE (THE LINER WAS NOT REVISED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 20628531 ↗
• InjuryNov 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INCIDENT REPORT RECEIVED BY THE TGA 15/09/2023. I'M CONCERNED AS THIS PRODUCT WAS ALERTED BY STRYKER IN JAN 2022 AS A VOLUNTARY RECALL. I'M WONDERING IF AUSTRALIA WAS ISSUED THE SAME ALERT? THERE ARE NUMEROUS DOCUMENTS THAT I HAVE FOUND ONLINE BY STRYKER STATING THE PRODUCT OF THIS LOT NUMBER WAS POSSIBLY DEFECTIVE AND WRONG SIZING COMPARED TO WHAT STATED ON PRODUCT PACKAGING. THERE WERE NUMEROUS COMPLICATIONS MENTIONED IN THE ALERTS THAT IT CAUSE LEG LENGTH DISCREPANCY, WEAKNESS OF THE ABDUCTOR MUSCLE, HIP DISLOCATION OF FEMORAL HEAD FROM ACETABULAR CUP, AND PAIN AND INABILITY TO WALK LEADING TO REVISION SURGERY. MY PARTNER HAD THIS DEVICE PUT IN HIM LAST YEAR ON (B)(6) 2022 AND HAD ALL THESE ISSUES PLUS MORE. THE PAIN AND SUFFERING HAS BEEN OVER 15 MONTHS AND VERY POOR MANAGEMENT POST CARE FROM THE SURGEON WHICH IS REALLY POOR DUTY OF CARE.

  Patient problems: Unequal Limb Length

  MAUDE report 18234583 ↗
• InjurySep 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A FRACTURED FEMORAL HEAD. INTRA-OPERATIVELY, THE HEAD WAS OBSERVED TO BE BROKEN INTO SEVERAL PIECES AND THE LINER WAS DAMAGED. SURGEON REPORTED THE PATIENT HAD A FALL ONE MONTH PRIOR. THE HEAD AND LINER WERE REVISED. REP REPORTED THAT PICTURES CAN BE PROVIDED, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall

  MAUDE report 15406490 ↗
• InjuryMar 1, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  PATIENT HAD RIGHT INDEX THA IN (B)(6) 2021. PATIENT PRESENTS WITH INSTABILITY AND RECURRENT DISLOCATION. UNDERGOES REVISION ON (B)(6) 2021 DUE TO LATERAL INSTABILITY ALTHOUGH WELL FIXED CUP. THE CUP, HEAD, AND LINER ARE EXCHANGED.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 13628769 ↗
• InjuryNov 30, 2021Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  AT THE REVISION, NO ONE NOTICED THAT THE PRODUCT INFORMATION AT THE PRIMARY SURGERY DID NOT MATCH BETWEEN SURGEON AND SALES REP SIDE. THE WRONG SIZE OF HEAD WAS USED, AND POSTOPERATIVE X-RAYS REVEALED IT, RESULTING IN REOPERATION. ONLY HEAD WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 12904199 ↗
• InjurySep 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IN REPORTING A REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2021, IT WAS REPORTED TO THE REP THAT A PRIOR REVISION WAS PERFORMED ON (B)(6) 2019 DUE TO RECURRENT DISLOCATIONS OF THE HEAD FROM THE LINER. A 36 +0 FEMORAL HEAD WAS REVISED TO A 36 +10 FEMORAL HEAD (REP CONFIRMED THE LINER WAS RETAINED). REP PROVIDED USAGE FROM THE PRIMARY AND SUBSEQUENT REVISIONS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 12432511 ↗
• InjuryDec 29, 2020Unstable; Unstable

  PROCEDURE: THE PATIENT HAD RIGHT TOTAL HIP REPLACEMENT OUTSIDE HOSPITAL (B)(6) 2011. AFTER THE HIP REPLACEMENT, PATIENT PRESENTED WITH INSTABILITY FAILURE, THEN UNDERWENT REVISION WITH REMAINING CUP, OTHER COMPONENTS EXCHANGED (B)(6) 2018. BECAUSE OF EXTENSIVE SOFT TISSUE DESTRUCTION THAT LED PATIENT PRESENTING SYMPTOM OF INSTABILITY, PATIENT UNDERWENT RIGHT TOTAL HIP REVISION LINER, HEAD, AND PROXIMAL RMS (BODY) COMPONENTS EXCHANGED ON (B)(6) 2019. THE PATIENT CONTINUES WITH INSTABILITY AND HAS A SECOND REVISION ON (B)(6) 2020 WHERE THE HEAD AND THE BODY OF THE RMS ARE EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11087823 ↗
• InjuryNov 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. A 36 + 0MM CERAMIC V40 HEAD WAS REVISED TO A 40 MM BIOLOX DELTA ANATOMIC UNIVERSAL TAPER FEMORAL HEAD WITH A +4 MM UNIVERSAL V40 TAPER ADAPTER SLEEVE. NO OTHER INFORMATION ABOUT THE REVISION WAS GIVEN.

  Patient problems: Insufficient Information

  MAUDE report 10913238 ↗
• InjuryOct 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION. A 36 +0 BIOLOX HEAD AND 36F 0° INSERT WERE REVISED TO AN MDM METAL LINER, ADM/ MDM POLY INSERT, AND 28MM BIOLOX HEAD WITH SLEEVE. REP PROVIDED USAGE SHEETS FROM THE PRIMARY AND REVISION PROCEDURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 10698355 ↗
• InjuryAug 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE SHELL AND TWO BROKEN SCREWS. INTRA-OPERATIVELY, WEAR WAS NOTED ON THE FEMORAL HEAD. THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. PATIENT WAS REVISED TO A TRIDENT 2 SHELL, MDM METAL LINER, ADM/MDM POLY INSERT, AND A BIOLOX HEAD WITH SLEEVE.

  Patient problems: Injury

  MAUDE report 10434968 ↗
• InjuryJun 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. A NOTE ON THE USAGE SHEET STATES "REVISED FOR INSTABILITY." A RESTORATION MODULAR CONE BODY AND 36 +7.5 BIOLOX HEAD WERE IMPLANTED.

  Patient problems: Injury

  MAUDE report 10113650 ↗
• MalfunctionApr 28, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  DOING A TOTAL HIP AND PUTTING REAL IMPLANTS IN. ACC 2 STEM WAS IMPLANTED AND WENT TO PUT THE CERAMIC V40 HEAD ON. THE TAPER WOULDN¿T LOCK ONTO THE STEM WITH THE HEAD. TRIED TO IMPACT THE HEAD MULTIPLE TIMES BUT WOULDN¿T LOCK. HAD TO OPEN A SECOND HEAD AND THE TAPER LOCKED ON JUST FINE. UPDATE (B)(6) 2020 : AS REPORTED IN HOW WAS ISSUE NOTICED: "AFTER THE HEAD WAS PLACED ON THE STEM AND IMPACTED THE SURGEON ALWAYS CHECKS TO MAKE SURE IT LOCKS ON. WHEN HE PULLED ON THE HEAD IT POPPED OFF. THE HEAD WAS NEW OUT OF THE BOX.". UPDATE 4/20/2020: "IT TOOK ABOUT 5 SECONDS TO GRAB ANOTHER HEAD AND OPEN THE BOX.".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10006521 ↗
• InjuryMar 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION (INFECTION CLINICALLY CONFIRMED, INFECTING MICROORGANISM NOT REPORTED TO REP). A 36 +0 CERAMIC HEAD AND 36 0° POLY LINER WERE REVISED TO A C-TAPER HEAD AND SLEEVE WITH A 36E LINER. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 8419933 ↗
• InjuryDec 12, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PATIENT APPEARED TO HAVE OFFSET ISSUES ON X-RAY". A 21MM +20 V40 RESTORATION PROXIMAL BODY AND 36 +0 BIOLOX V40 HEAD WERE REVISED TO A 25MM +20 V40 RESTORATION PROXIMAL BODY AND ANOTHER 36 +0 BIOLOX V40 HEAD.

  Patient problems: Injury

  MAUDE report 8156040 ↗
• InjuryDec 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A PRIMARY AND REVISION IMPLANT SHEET THAT PATIENT'S LEFT HIP WAS REVISED. A 36 +0 BIOLOX HEAD WAS REVISED TO A 36 -5 BIOLOX HEAD.

  Patient problems: Injury

  MAUDE report 8131122 ↗
• InjuryOct 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PREOP DX: HEMATOMA LEFT HIP STATUS POST ARTHROPLASTY. I & D LEFT HIP, POLY & FEMORAL HEAD EXCHANGE.

  Patient problems: Hematoma; Injury

  MAUDE report 8010180 ↗
• MalfunctionAug 21, 2018Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  FOUND HAIR INSIDE STERILE PACK AFTER OPENING IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800657 ↗
• MalfunctionApr 30, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING A PRIMARY HIP SURGERY, IT WAS REPORTED THAT UPON OPENING THE IMPLANT, A BLACK RESINOUS SUBSTANCE WAS OBSERVED ON THE IMPLANT. ANOTHER IMPLANT WAS IMMEDIATELY AVAILABLE IN THE FIELD AND THERE WAS NO SURGICAL DELAY WHATSOEVER. REP WAS PRESENT AND WITNESSED THE IMPLANT OPENING BUT HOSPITAL WASHED THE IMPLANT BEFORE THE REP COULD RETRIEVE IT. REP HAS NO PICTURES OF THE DEVICE PRIOR TO WASHING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7474777 ↗
• InjuryMar 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO LIMB LENGTH DISCREPANCY. THE SURGEON REPORTED THAT THE PATIENT HAD A PREVIOUS SPINE SURGERY WHICH RESULTED IN A TILTED PELVIS, CAUSING THE DISCREPANCY. PATIENT WAS REVISED TO A FEMORAL HEAD WITH A LARGER OFFSET AS WELL AS A SLEEVE.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 7333971 ↗
• InjuryJun 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED, PATIENT WENT IN FOR A HIP REVISION DUE TO INFECTION ON (B)(6) 2017 BUT SURGEON COULD NOT DISSOCIATE HEAD FROM TRUNNION. SURGEON PERFORMED AN I&D. ADDITIONAL INFORMATION: NOTHING HAS BEEN REMOVED FROM ORIGINAL SURGERY. THEY COULD NOT DISASSOCIATE THE HEAD FROM THE TRUNNION. THE PATIENT IS OBESE AND WITH THE HEAD ON THEY COULD NOT ACCESS THE LINER TO SWAP IT OUT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6668684 ↗