Biolox® delta 00-8775-032-02 (UDI 00889024430327)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00889024430327), received between Nov 12, 2018 and Jun 30, 2026 — classified as 51 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (29 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 4 MONTHS POST-IMPLANTATION DUE TO INSTABILITY. PRIOR TO REVISION, THE PATIENT SUSTAINED A FALL AND EXPERIENCED SUBLUXATION OF THE JOINT. THE REVISION WAS PERFORMED USING A DIRECT ANTERIOR APPROACH TECHNIQUE. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 25673245 ↗
• MalfunctionJan 13, 2026Contamination; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A HAIR WAS OBSERVED UNDER THE TYVEK LID, ON THE IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050964 ↗
• InjuryNov 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 23671142 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT..

  Patient problems: Loss of Range of Motion; Pain; Unequal Limb Length

  MAUDE report 23496034 ↗
• InjuryNov 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 23468565 ↗
• InjuryOct 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL INFORMATION.

  Patient problems: Joint Dislocation

  MAUDE report 23403748 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Bursitis; Pain

  MAUDE report 22897818 ↗
• InjuryJul 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 MONTH LATER DUE TO DISLOCATION AND INSTABILITY. DURING THE REMOVAL OF THE HEAD, THE STEM CAME LOOSE. ALL DEVICES WERE REVISED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening; Joint Dislocation; Joint Laxity

  MAUDE report 22509353 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 3 YEARS AND 9 MONTHS POST IMPLANTATION DUE TO HETEROTROPHIC OSSIFICATION FROM HIP JOINT. THE FEMORAL HEAD WAS REMOVED TO ALLOW JOINT ACCESS AND THEN REPLACED WITH A BIOLOX OPTION HEAD TO FACILITATE THE USE OF A TAPER SLEEVE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Extraskeletal ossification

  MAUDE report 21561739 ↗
• InjuryMar 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 21504763 ↗
• InjuryFeb 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Muscle/Tendon Damage

  MAUDE report 21358601 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE APPROPRIATE IMPLANT WAS SELECTED FOR THE PATIENT. SUBSEQUENT TO IMPLANTATION, THE PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE IN THE ACETABULUM. IT IS NOT KNOWN WHAT CAUSED THE FRACTURE. THE PATIENT WAS REVISED AND A LARGER IMPLANT USED AS A RESULT OF THE FRACTURE THAT HAD OCCURRED FOR BETTER FIXATION. THE PATIENT IS REPORTED TO BE DOING WELL AFTER THE REVISION SURGERY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s)

  MAUDE report 21042164 ↗
• InjuryNov 5, 2024Device Dislodged or Dislocated; Separation Problem; Device Dislodged or Dislocated; Separation Problem

  IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 21 DAYS POST IMPLANTATION DUE TO A DISLOCATION CAUSED BY A FALL IN THE DOMESTIC ENVIRONMENT. DURING THE INTRAOPERATIVE ATTEMPT TO DETACH THE HEAD FROM THE STEM, THE HEAD AND STEM CAME OUT OF THE MEDULLARY CAVITY OF THE FEMUR AFTER THE THIRD STROKE. AS A RESULT, THE MEDULLARY CANAL HAD TO BE PARTIALLY FREED FROM THE CEMENT IN ORDER TO BE ABLE TO PLACE A NEW STEM INCLUDING A NEW THIN CEMENT MANTLE AND A HEAD WITH MORE OFFSET HAD TO BE IMPLANTED. DELAY 60 MINUTES FOR COMPLEX PARTIAL REMOVAL OF THE CEMENT IN THE FEMUR TO MAKE ROOM FOR RE-IMPLANTATION AND PARTIAL NEW CEMENT MANTLE, TRIAL REDUCTION, RE-IMPLANTATION INCLUDING HARDENING OF THE CEMENT, REDUCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 20613855 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS TREATED WITH A CORTISONE INJECTION IN THE LEFT HIP FOR BURSITIS. ALL COMPONENTS REMAIN IMPLANTED, NO PLANS FOR FUTURE REVISION AT THIS TIME. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED

  Patient problems: Bursitis

  MAUDE report 20200764 ↗
• InjuryJul 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DILIGENCE IS COMPLETED AND NO FURTHER EVENT INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Dislocation; Pain

  MAUDE report 19714868 ↗
• InjuryJul 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INITIAL LEFT TOTAL HIP ARTHROPLASTY FOLLOWED BY AN I&D FOR EXCESSIVE DRAINAGE AND HEMATOMA REQUIRING JOINT DEBRIDEMENT APPROXIMATELY 1 MONTH LATER. SUBSEQUENTLY WHILE IN 6 IN. OF WATER BENT OVER AT WAIST AND DISLOCATED LEFT HIP AND HAD A CLOSED REDUCTION IN THE ER APPROXIMATELY 1.5 YEARS POST-IMPLANTATION. 3 DAYS LATER, PATIENT WAS SEEN IN THE OFFICE AND GIVEN A BRACE WITH FOLLOW UP IN 6 WEEKS. 1 MONTH LATER, THERE WAS A 2ND DISLOCATION WHILE GETTING UP FROM STOOL AND FELL. CLOSED REDUCTION IN THE ER WITH BRACE APPLIED. APPROXIMATELY 2 YEARS POST-IMPLANTATION, THE PATIENT WAS REVISED DUE TO SUBSEQUENT ENCOUNTERS OF DISLOCATION. THE HEAD AND LINER WERE EXCHANGED WITHOUT COMPLICATIONS. THE CUP AND FEMUR REMAINED IMPLANTED. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Joint Dislocation

  MAUDE report 19702594 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN INITIAL TOTAL LEFT HIP ARTHROPLASTY WHICH REQUIRED A REVISION THE VERY NEXT DAY DUE TO ISSUES WITH SIZE MISMATCHING. APPROXIMATELY 6 MONTHS POST-REVISION THE PATIENT REPORTED BILATERAL HIP PAIN WITH LEFT HIP BEING GREATER THAN THE RIGHT, AND AN INABILITY TO WALK UP OR DOWN STAIRS. PATIENT WAS PRESCRIBED AQUA THERAPY BUT HAS YET TO START. APPROXIMATELY 2 YEARS POST-REVISION, THE PATIENT UNDERWENT A SPINAL CORD SURGERY FOR UNKNOWN REASONS. DURING A FOLLOW-UP APPOINTMENT FOR THIS PROCEDURE APPROXIMATELY 1 WEEK LATER, THE PATIENT REPORTED 100% PAIN RELIEF. NO FURTHER ALLEGATIONS HAVE BEEN REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unequal Limb Length

  MAUDE report 18923541 ↗
• InjuryOct 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO HIP DISLOCATION APPROXIMATELY FIVE YEARS POST INITIAL IMPLANTATION. IT WAS NOTED THAT DURING THE REVISION SURGERY, SIGNIFICANT METAL DEBRIS (BLACK TISSUE) WAS ALSO FOUND IN THE PATIENT'S WOUND. UPON EXAMINATION, IT WAS FOUND THAT THE ANTERIOR NECK HAD BEEN GRINDING ON THE ANTERIOR NECK OF THE ACETABULAR CUP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Joint Dislocation; Joint Impingement; Metal Related Pathology; Pain

  MAUDE report 17948143 ↗
• InjuryOct 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: Joint Dislocation

  MAUDE report 17874975 ↗
• MalfunctionAug 14, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT COSMETIC DAMAGE WAS OBSERVED ON THE DELTA CERAMIC HEAD. THE ITEM WAS NOT USED FOR THE SURGERY. NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538943 ↗
• InjuryJun 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 17222790 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO A PERIPROSTHETIC FRACTURE. THE HEAD AND NECK WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 16851583 ↗
• MalfunctionApr 18, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON NOTICED A DEFECT/SCRATCH ON THE CERAMIC HEAD IMPLANT. THE SURGERY WAS COMPLETED WITH A DIFFERENT IMPLANT. NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16760835 ↗
• InjuryMar 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE A DUPLICATE OF MEDWATCH # MDR296580, REPORT NUMBER 0009613350-2021-00557. HENCE THIS REPORT SHOULD BE VOIDED.

  Patient problems: Joint Dislocation

  MAUDE report 16625477 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EVALUATED IN THE ER FOR PULMONARY EMBOLISM RECEIVING IV DYE LEADING TO ANAPHYLACTIC SHOCK AND RESPIRATORY FAILURE ABOUT TWO MONTHS AFTER INITIAL LEFT TOTAL HIP ARTHROPLASTY. DURING HOSPITALIZATION PATIENT WAS ALSO DIAGNOSED WITH AN UNKNOWN INFECTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Pulmonary Embolism; Unspecified Infection

  MAUDE report 16321130 ↗