BIOLOX OPTION HIP SYSTEM 650-1067Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304521964), received between Oct 8, 2019 and Feb 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K082996); they may or may not involve this specific model.

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.

• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIX YEARS AGO THE PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY. FOUR YEARS LATER THE PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO SEVERE RIGHT INGUINAL PAIN. THE PATIENT REPORTED SHE HAD STARTED PILATE'S AND NEW EXERCISES. X-RAYS SHOWED THE IMPLANTS WERE IN SATISFACTORY POSITION WITHOUT COMPLICATIONS. THE PATIENT WAS DIAGNOSED WITH HIP FLEXOR TENDONITIS, INSTRUCTED TO LIMIT EXERCISES FOR TWO WEEKS, AND WAS PRESCRIBED AN ORAL STEROID DOSE PACK. THE PATIENT DID WELL UNTIL A YEAR AGO, WHEN REPORTED TO THE CARE TEAM OF WORSENING GROIN PAIN ALONG WITH DIFFICULTY RAISING LEG. THE PATIENT WAS GIVEN AN ULTRASOUND AND FLUOROSCOPICALLY GUIDED RIGHT PSOAS BURSA INJECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Inflammation; Pain

  MAUDE report 21444500 ↗
• InjuryOct 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. DURING THE SURGERY, ALL COMPONENTS WERE REMOVED AND REPLACED.

  Patient problems: No Information

  MAUDE report 9165248 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082996. One submission often covers many models, so check the product and lot details in each record.

• Z-3133-2024 · Aug 8, 2024 · Open, Classified
  Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1
• Z-3132-2024 · Aug 8, 2024 · Open, Classified
  Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 6
• Z-0302-2018 · Jun 5, 2017 · Terminated
  CER BIOLOXD OPTION HD 32MM, model # 650-1056
• Z-0301-2018 · Jun 5, 2017 · Terminated
  CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064