BIOLOX® delta Modular Ceramic Head 650-1161Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887868271557), received between Apr 2, 2020 and Jan 14, 2026 — classified as 11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SEVEN MONTHS POST LEFT HIP IMPLANTATION, THE PATIENT RECEIVED TREATMENT FOR PAIN IN THEIR LEFT THIGH. FOLLOWING LONG WALKS, THERE IS RADIATING STABBING PAIN FROM BUTTOCKS DOWN THE THIGH AND KNEE. THE PATIENT HAS RECEIVED A CORTISONE INJECTION FOR PAIN IN THE LEFT BURSA. THE PATIENT UNDERGOES WEEKLY PHYSICAL THERAPY, MASSAGE, AND EXERCISES. SIX MONTHS LATER, THE PATIENT REPORTED MILD PAIN WITH LITTLE DIFFICULTIES AND NO REQUIRED PAIN MEDICATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 24065742 ↗
• InjurySep 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION. APPROXIMATELY 21 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 23071143 ↗
• InjuryAug 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 22858927 ↗
• InjuryMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY SEVEN WEEKS AFTER IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A FEMORAL HEAD FRACTURE. THERE WAS NO REPORTED TRAUMA, AND THE CAUSE OF THE FRACTURE REMAINS UNKNOWN. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 21713741 ↗
• InjurySep 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED THREE YEARS AND THREE MONTHS POST IMPLANTATION DUE TO DISLOCATION. THE PATIENT HAS A STIFF SPINE CAUSING DISLOCATIONS. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 20167941 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER A RIGHT THA, THE PATIENT EXPERIENCED A THROMBOSIS APPROXIMATELY SIX WEEKS POSTOP. PATIENT WAS TREATED WITH ANTICOAGULANT THERAPY AND THE EVENT WAS RESOLVED SEVEN MONTHS LATER. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17851300 ↗
• InjurySep 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 17681797 ↗
• InjuryNov 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT 2-WEEK POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE. IT WAS PROVED BY THE X-RAY TAKEN DURING POST OP FOLLOW UP VISIT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 15850550 ↗
• InjuryJun 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT: THE CERAMIC FEMORAL HEAD FRACTURED 3 WEEKS POSTOP, THE COMPLICATION REQUIRED REVISION SURGERY. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 14560016 ↗
• MalfunctionApr 19, 2022Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED, THAT: DURING PRIMARY HIP REPLACEMENT TAPERLOC COMPLETE WITH ALLOFIT CUP, THE CERAMIC BIOLOX HEAD BROKE BY HITTING THE HEAD ON THE STEM. CORRECT TECHNIQUE AND INSTRUMENTS ARE USED. PATIENT INVOLVEMENT - NO FURTHER OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140350 ↗
• InjurySep 14, 2020Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING PRIMARY HIP SURGERY, THE CERAMIC HEAD FRACTURED AFTER REPOSITIONING.

  Patient problems: No Information

  MAUDE report 10527793 ↗
• InjuryApr 2, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DAY IN (B)(6) 2019. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO MIGRATION WAS PERFORMED ON (B)(6) 2020.

  Patient problems: Pain

  MAUDE report 9915335 ↗