Biolox® Option 00-8777-036-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024430518), received between Aug 22, 2019 and Jun 4, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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

• InjuryJun 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 19459310 ↗
• InjuryMar 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY ELEVEN (11) YEARS LATER DUE TO RECURRENT ANTERIOR DISLOCATIONS. THE PATIENT DID WELL UNTIL SIX (6) YEARS LATER WHEN SHE BENT OVER AND DISLOCATED POSTERIORLY, WHICH WAS REDUCED IN THE EMERGENCY ROOM. AFTER RECURRENT DISLOCATIONS FOLLOWING, THE PATIENT UNDERWENT A SECOND HEAD AND LINER EXCHANGE APPROXIMATELY SEVEN (7) YEARS AFTER REVISION. THE CUP AND STEM WERE STABLE AND LEFT INTACT. A NEW HEAD AND CONSTRAINED LINER WERE PLACED WITHOUT COMPLICATIONS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 16467158 ↗
• InjuryAug 24, 2020Appropriate Device Problem Term/Code Not Available

  THE PRODUCT WAS IMPLANTED ON LEFT SIDE AND PATIENT MAY REQUIRE ANOTHER (SECOND) REVISION SURGERY DUE TO LARGE POSTOPERATIVE FLUID COLLECTION ALONG THE LEFT GREATER TROCHANTER OF THE HIP, WHICH WAS DISCOVERED UPON FOLLOW UP MRI.

  Patient problems: Pain

  MAUDE report 10441415 ↗
• InjuryAug 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION DUE TO INFECTION WITHIN FOUR MONTHS OF IMPLANTATION.

  Patient problems: Unspecified Infection

  MAUDE report 8919635 ↗