BIOLOX OPTION HIP SYSTEM 650-1065Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304521940), received between Jun 8, 2021 and Feb 29, 2024 — classified as 3 injuries.

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 16, 2026.

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.

• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY LEGAL ALLEGATIONS THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY SIXTEEN YEARS AGO FOLLOWED BY A REVISION ABOUT SEVEN YEARS POST IMPLANTATION DUE METAL RELATED PATHOLOGY. SUBSEQUENTLY, THE PATIENT HAD A CHRONIC TROCHANTERIC AVULSION FRACTURE AND DEVELOPED PAIN, STIFFNESS, RANGE OF MOTION ISSUES, AND A FALL THAT LED TO ONGOING DIAGNOSTIC TESTS WITH SUSPICION OF ALVAL. APPROXIMATELY TWO YEARS AGO, THE PATIENT UNDERWENT A STAGE I REVISION FOR INFECTION. DURING THE PROCEDURE, A SMALL FRACTURE OF THE ANTERIOR CORTEX OCCURRED FROM THE WEDGING OF THE OSTEOTOME, THE PATIENT EXPERIENCED BLOOD LOSS, ALL IMPLANTS WERE REMOVED, AND A COMPETITOR CEMENT SPACER WAS IMPLANTED. STAGE II REVISION FOLLOWED ONE AND A HALF MONTHS LATER WITH COMPETITOR PRODUCT IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bacterial Infection; Bone Fracture(s); Fall; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Loss of Range of Motion; Muscle/Tendon Damage; Osteolysis; Pain

  MAUDE report 18811059 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Inflammation; Loss of Range of Motion; Pain

  MAUDE report 18482114 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED (B)(6) 2018. SUBSEQUENTLY, THE PATIENT UNDERWENT SCREW REMOVAL AND HEAD AND LINER EXCHANGE ON (B)(6) 2019 DUE TO SCREW MIGRATION. APPROXIMATELY ONE MONTH LATER, THE PATIENT DEVELOPED A SUPERFICIAL INFECTION AT THE INCISION SITE. SUPERFICIAL IRRIGATION AND DEBRIDEMENT WAS PERFORMED ON (B)(6) 2019. NO PRODUCT WAS EXCHANGED AS THE INFECTION DID NOT PENETRATE THE JOINT SPACE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11955629 ↗

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-0301-2018 · Jun 5, 2017 · Terminated
  CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
• Z-0302-2018 · Jun 5, 2017 · Terminated
  CER BIOLOXD OPTION HD 32MM, model # 650-1056