BIOLOX® Option 650-1064Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887868271465), received between Oct 12, 2021 and Mar 11, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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. Aug 8, 2024Class IIOpen, Classified

   Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6

   Z-3133-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY ONE YEAR AND SIX MONTHS POST IMPLANTATION DUE TO THIGH PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 18873296 ↗
• InjuryJan 16, 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: Pulmonary Embolism

  MAUDE report 18516128 ↗
• InjuryMay 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION SURGERY SINCE THE ORIGINAL TOTAL HIP REPLACEMENT WAS PERFORMED APPROXIMATELY (7) YEARS AGO. RECENTLY, A REVISION HAS BEEN PERFORMED DUE TO DISLOCATION. REVISED TO HEAD AND LINER. NO FURTHER OUTCOME. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 16960074 ↗
• InjuryJan 19, 2023Adverse 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: Bacterial Infection

  MAUDE report 16202066 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS DIAGNOSED WITH POST-OPERATIVE LEFT POPLITEAL, DEEP VEIN THROMBOSIS DESPITE FRAGMIN PRESCRIPTION. SYMPTOMS OF CALF TENSION AND MINIMAL REDNESS BEGAN THREE DAYS AFTER LEFT TOTAL HIP ARTHROPLASTY. THE THROMBOSIS WAS RESOLVED WITHOUT COMPLICATIONS; ALL IMPLANTS REMAINED IN PLACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Thromboembolism

  MAUDE report 15444171 ↗
• InjuryFeb 8, 2022Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED, THAT: A PATIENT UNDERWENT A REVISION OF THE RIGHT HIP ON (B)(6) 2021, DUE TO UNKNOWN REASONS. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO DISLOCATION (FEMORAL HEAD BECAME DISASSOCIATED FROM DM POLY LINER) WAS PERFORMED ON (B)(6) 2022. NO FURTHER OUTCOME.

  Patient problems: Failure of Implant

  MAUDE report 13480258 ↗
• InjuryOct 12, 2021Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  THE E1 ACTIVE ARTICULATION BEARING OF THE G7 DUAL MOBILITY IMPLANTED ON (B)(6) 2017 HAS DISLODGED FROM THE AETABULAR CUP. THE PATIENT WAS SUSPECTED OF HAVING IPD WHEN HE UNDERWENT MANUAL REDUCTION DUE TO THE HEAD BEING REMOVED FROM THE E1AA BEARING. IT WAS CONFIRMED THAT THE BEARING HAD COME OFF THE CUP DURING THE REVISION SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 12613513 ↗