BIOLOX® Delta Hip System 12-115121Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868248481), received between Mar 5, 2020 and Aug 9, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2023Device 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 17486858 ↗
• InjuryJun 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: High metal ion levels; Metal Related Pathology; Pain

  MAUDE report 17197786 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 17009344 ↗
• InjuryMar 5, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED BENDING OVER TO USE A DUST PAN AND FELT 3 POPS AND GRINDING. THE PATIENT WAS REVISED. ONCE THE INCISION WAS MADE, IT WAS NOTICED THAT THE BIOLOX HEAD WAS CRACKED IN HALF.

  Patient problems: Failure of Implant

  MAUDE report 9791741 ↗