BIOLOX® Option 650-1067Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868271496), received between Apr 8, 2020 and Mar 28, 2024 — classified as 4 injuries.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ELEVEN DAYS AFTER A LEFT HIP PROCEDURE, THE PATIENT UNDERWENT A REVISION DUE TO PAIN AND CUP INSTABILITY. THE CUP INSTABILITY WAS ATTRIBUTED TO PATIENT POOR BONE QUALITY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18999451 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: INITIAL LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT EXPERIENCED A POSTOP SEROMA REQUIRING ADDITIONAL MEDICAL INTERVENTION AND RESOLVED (B)(6) 2021.

  Patient problems: Seroma

  MAUDE report 12553034 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 11 MONTHS POST IMPLANTATION DUE TO AN INFECTION. NO ADDITIONAL INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 11365279 ↗
• InjuryApr 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT THA. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN ANTERIOR DISLOCATION IN POSTOP RECOVERY ROOM. MANIPULATION UNDER SEDATION WAS PREFORMED, THEN X-RAYS REVEALED AN UNSTABLE HIP SO THE PATIENT WAS BROUGHT BACK TO THE OR FOR A REVISION SURGERY.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 9937367 ↗