Biolox 18-2800Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154187256), received between May 14, 2019 and Jul 18, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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.

• InjuryJul 18, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. AN ADM/ MDM POLY INSERT, MDM METAL LINER, CERAMIC HEAD AND SLEEVE AND 2 SCREWS WERE REVISED TO A CONSTRAINED LINER AND NEW FEMORAL HEAD. REP CONFIRMED THAT INTRA-OPERATIVELY NO IMPLANTS WERE NOTED TO BE WORN, LOOSE, OR DAMAGED.

  Patient problems: Joint Laxity

  MAUDE report 15046359 ↗
• InjuryMay 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. THE SURGEON REPORTED THAT THE SHELL WAS "A LITTLE VERTICAL". A PRE-REVISION X-RAY PROVIDED BY THE REP ALSO CITES A LIMB LENGTH DISCREPANCY OF 7MM. INTRA-OPERATIVELY, THE SHELL AND STEM WERE NOTED TO BE WELL-FIXED. REP ALSO PROVIDED PRIMARY AND REVISION IMPLANT SHEETS AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 8609021 ↗