BIOLOX® Delta Hip System 12-115123Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868248504), received between Mar 16, 2021 and Apr 1, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2022Fracture; Fracture

  IT WAS REPORTED, THAT: PATIENT ARRIVED VIA THE ER WITH HIP INSTABILITY AND REPORTED A LOUD PING SOUND PRIOR TO REPORTED INSTABILITY WHILE AT HOME. X-RAY SHOWED WHAT APPEARED TO BE A FRACTURED BIOLOX CERAMIC FEMORAL HEAD. PATIENT WAS TAKEN TO OR LATER THAT DAY AND THE BROKEN FEMORAL HEAD REMOVED, CONFIRMED VIA X-RAY THAT ALL PIECES WERE REMOVED, AND A NEW BIOLOX OPTION FEMORAL HEAD AND NEW HIWALL G7 LINER RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 13975116 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021 DUE TO LEG LENGTH DISCREPANCY. THE STEM, HEAD AND LINER WERE REMOVED AND REPLACED.

  Patient problems: Unequal Limb Length

  MAUDE report 11491767 ↗