BIOLOX® delta Modular Ceramic Head 650-0663Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00887868271199), received between Jul 15, 2022 and Jul 28, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT REVISION SURGERY SEVEN DAYS POST AN INITIAL LEFT HIP PROCEDURE DUE TO A BONE FRACTURE. THE PATIENT COULD NOT DENY OR CONFIRM THAT THE FRACTURE TOOK PLACE WHEN HE HAD A FALL AT HOME THREE DAYS POST OP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22635986 ↗
• InjuryDec 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT A DAY AFTER IMPLANTATION, THE PATIENT FELT A SNAP IN THE HIP WHILE WALKING. DURING THE SUBSEQUENT SURGERY, IT WAS FOUND THAT THE CERAMIC FEMORAL HEAD HAD SPLIT IN TWO. 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 20862789 ↗
• InjuryAug 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 20000088 ↗
• InjuryJul 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 19679367 ↗
• InjuryMay 11, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. A WEEK LATER THE PATIENT DISLOCATED HIS HIP. ELEVEN DAYS POST-IMPLANTATION, REVISION HIP SURGERY WAS PERFORMED. THE CERAMIC HEAD WAS SPLIT IN HALF IN THE PATIENT. ONE TO TWO SMALL HEAD PIECES WERE FOUND WHILE EXPLORING AND IRRIGATING THE WOUND. THEY WERE SEQUESTERED AND THE HEAD WAS REPLACED WITH A NEW, CERAMIC ONE, ALSO THE LINER WAS EXCHANGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation; Loss of Range of Motion; Osteopenia/ Osteoporosis; Pain

  MAUDE report 16909765 ↗
• InjuryApr 25, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 16804928 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION DUE TO THE INFECTION APPROXIMATELY THREE (3) MONTHS POST-OP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 15082234 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS APPROXIMATELY 3 MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15081659 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY AND APPROXIMATELY A MONTH LATER A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 15037456 ↗
• MalfunctionJul 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY THE CERAMIC HEAD BROKE WHILE THE SURGEON WAS REMOVING IT FROM THE STEM TAPER. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 15026697 ↗