BIOLOX® delta Modular Ceramic Head 650-1157Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00887868271519), received between Nov 30, 2022 and Mar 24, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY FOUR MONTHS AND ONE WEEK POST IMPLANTATION DUE TO FEMORAL HEAD FRACTURE. PATIENT STATED HE DID NOT FALL THOUGH HAD A MISSTEP WHICH WAS JARRING WHERE HE CAUGHT HIS BODY WEIGHT ON THE SIDE WHERE THE DAMAGED COMPONENT. THEN, THE PATIENT HEARD A POP AND FELL TO THE GROUND AT THE TIME THE IMPLANT BROKE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 24679356 ↗
• MalfunctionOct 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CERAMIC FEMORAL HEAD FRACTURED UPON IMPACTION WITH THE MALLET. THE SURGEON CONFIRMED THAT APPROPRIATE TECHNIQUE AND FORCE WERE USED, AND NO EXCESSIVE FORCE WAS APPLIED. NO FRAGMENTS FELL OR WERE RETAINED IN THE PATIENT. THERE WERE NO REPORTED CONSEQUENCES OR HEALTH IMPACTS TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334484 ↗
• InjuryJul 8, 2025Fracture; Fracture

  THE INCIDENT REPORTED UNDER (B)(4), MFR REPORT NUMBER: 3002806535-2025-00253, CAN BE CLOSED AS A DUPLICATE OF THE COMPLAINT (B)(4), MFR REPORT NUMBER: 3002806535-2025-00249.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434292 ↗
• MalfunctionJul 7, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413327 ↗
• InjuryMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A PERIPROSTHETIC FRACTURE. THE PATIENT ALSO DISLOCATED THEIR HIP AS A RESULT OF THE FRACTURE. THE BEARING AND HEAD DISLOCATED. THERE WAS INTERNAL FIXATION OF THE FEMUR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 21965875 ↗
• InjuryOct 30, 2024Fracture; Malposition of Device; Detachment of Device or Device Component; Fracture; Malposition of Device; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 20569721 ↗
• InjuryJul 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT EXPERIENCED PAIN AFTER SHOWERING. INTRA-PROSTHETIC DISLOCATION (DISASSOCIATION) WAS NOTED, RESULTING IN A HEAD AND LINER EXCHANGE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17286760 ↗
• InjuryNov 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF HIP PROSTHESIS DUE TO CERAMIC HEAD FRACTURE, APPROXIMATELY 8 YEARS POST OP. 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 15884331 ↗