BIOLOX delta 71325174Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556499191), received between Jul 7, 2021 and Jul 7, 2021 — classified as 1 injury.

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

• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021 TO DO INCISION AND DRAINAGE AND EXCESSIVE IRRIGATION WAS DONE. THE SURGEON DECIDED TO CHANGE THE R3 US DELTA HEAD 36 +0 TO STOP THE PROGRESSION OF THE INFECTION AND AVOID FURTHER REMOVAL OF ALL THE ORIGINAL TOTAL HIP IMPLANTS, EVEN THOUGH THIS CHANGE IS NOT RECOMMENDED BY SURGICAL TECHNIQUE. HEALTH STATUS OF PATIENT IS NORMAL.

  Patient problems: Unspecified Infection

  MAUDE report 12129265 ↗