Biolox® Option 00-8777-040-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024430563), received between Dec 6, 2019 and May 21, 2026 — classified as 3 injuries.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 2, 2023Class IIOpen, Classified

   One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.

   Z-0570-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN INITIAL LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 12 YEARS EARLIER. AROUND MID-2021, THE PATIENT ACCIDENTALLY FELL AND SUSTAINED A SMALL FRACTURE TO THE ACETABULAR FLOOR BENEATH THE CUP. A FEW MONTHS LATER, RADIOGRAPHIC IMAGING DISPLAYED SINKING OF THE CUP WITH EVIDENT BONE DEFICIT AT THE ACETABULAR ROOF, AND SERUM COBALT AND CHROMIUM LEVELS WERE ELEVATED. SEVERAL MONTHS LATER, THE PATIENT UNDERWENT AN ACETABULAR REVISION AND REACTIVE GRAY SYNOVITIS OF A METALLOSIS TYPE AT THE STEM AND ACETABULUM, TRUNNIONOSIS, AND ABSENCE OF THE ANTERIOR WALL WITH EXTENSIVE ACETABULAR OSTEOLYSIS WERE FOUND. THE FRACTURED BONE FRAGMENT WAS SYNTHESIZED WITH TWO CORTICAL SCREWS AND ALL OTHER COMPONENTS WERE REVISED EXCEPT FOR THE STEM. POST-OPERATIVELY, THE PATIENT¿S HEMOGLOBIN DROPPED TO 7.6 G/DL AND REQUIRED ONE UNIT OF TRANSFUSED RED BLOOD CELLS. THE PATIENT WAS UNDERGOING A SLOW PROGRESSIVE RECOVERY AND, SEVERAL MONTHS LATER, AFTER A SHORT WALK WITH WEIGHT BEARING, HAD AN ONSET OF PAIN. RADIOGRAPHIC IMAGING DISPLAYED A PERIPROSTHETIC FLUID COLLECTION, RESORPTION OF THE GRAFT, AND CUP PROTRUSION, AND SUBSEQUENTLY THE PATIENT UNDERWENT AN ULTRASOUND

  Patient problems: Anemia; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inadequate Osseointegration; Joint effusion; Osteolysis; Pain; Unequal Limb Length

  MAUDE report 25248523 ↗
• InjuryNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Fall; Hematoma; Joint Dislocation; Tissue Breakdown

  MAUDE report 20726695 ↗
• InjuryDec 6, 2019Appropriate 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 9424779 ↗