Biolox 18-3205Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154187294), received between Mar 23, 2021 and Mar 23, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR THE HIP REVISION. THE HIP WAS DISLOCATED POSTERIORLY. THERE WAS EXTENSIVE BLACKENED TISSUE WITHIN THE HIP JOINT ITSELF FROM TITANIUM STAINING. IT WAS OBVIOUS THAT THE POLYETHYLENE LINER HAD ROTATED OUT OF POSITION AND THE CERAMIC HEAD WAS ARTICULATING WITH THE INSIDE OF THE SOCKET. WE DISENGAGED THE HEAD, WE MOBILIZED THE STEM, RETRACTED IT ANTERIORLY. WE REPLACED THE 10° LIPPED LINER. HOWEVER, WITH THIS IMPLANT, IT APPEARED THAT IT WAS NOT LOCKING SOLIDLY IN PLACE. I EXTRACTED THAT AND ATTEMPTED TO CEMENT THE LINER IN PLACE, BUT WE WERE UNABLE TO OBTAIN A VERY STABLE INTERFACE. AT THAT POINT, WE REMOVED THE LINER AND CEMENT AND REPLACED THE LINER WITH A NEW LINER THAT LOCKED CLEARLY VERY SOLIDLY IN PLACE (INTRA-OP EVENT REPORTED). THIS GAVE GOOD RANGE OF MOTION, GOOD ORIENTATION OF COMPONENTS. WE THEN THOROUGHLY IRRIGATED AND DEBRIDED ALL TITANIUM STAINED TISSUE AND RECONSTRUCTED THE POSTERIOR CAPSULE IN AN ANATOMIC FASHION, CLOSED THE WOUND IN THE USUAL FASHION. STERILE DRESSINGS APPLIED. THE PATIENT WAS AWAKENED AND REMOVED FROM THE OPERATING ROOM IN GOOD CONDITION.

  Patient problems: Arthritis; Joint Dislocation; Pain

  MAUDE report 11555862 ↗