Biolox® Option 00-8777-036-04 (UDI 00889024430549)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024430549), received between Sep 21, 2020 and Jun 7, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2022Device Dislodged or Dislocated; Human-Device Interface Problem; Device Dislodged or Dislocated; Human-Device Interface Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE RIGHT HIP APPROXIMATELY SEVEN YEARS POST IMPLANTATION DUE TO MULTIPLE DISLOCATIONS. DURING THE REVISION, THE FOLLOWING OBSERVATIONS WERE NOTED: RUPTURED FASCIA LAYER, CAPSULE AND SHORT EXTERNAL ROTATORS DEFICIENT, INSTABILITY, POOR TISSUE TENSION, AND PROXIMAL FEMUR FRACTURE WHILE REMOVING STEM. THE STEM, HEAD AND POLYETHYLENE LINER WERE EXCHANGED, AND CERCLAGE WIRE PLACED ON FEMUR. THE SHELL REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 14614052 ↗
• InjurySep 2, 2021Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 12414000 ↗
• InjuryMar 12, 2021Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 11471459 ↗
• InjuryOct 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION SURGERY DURING WHICH PATIENT WAS IMPLANTED WITH A BIOLOX HEAD. SUBSEQUENTLY, THE PATIENT EXPERIENCED IMPLANT DISLOCATION AND REQUIRED MEDICAL INTERVENTION TO RE-ESTABLISH COMPONENT POSITIONING.

  Patient problems: No Code Available

  MAUDE report 10654585 ↗
• InjurySep 21, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10559501 ↗