BIOLOX delta 71325172Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556499092), received between Mar 14, 2021 and Aug 31, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A THR, THE INNER STERILE PACKAGING OF A R3 US DELTA HEAD 32 +4 WAS SHATTERED. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20114263 ↗
• InjuryJun 13, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER A THR, IT WAS NOTICED THAT THE R3 US DELTA HEAD 32 +4 WAS IMPLANTED WITH A 36 LINER, WHICH IS A SIZE MISMATCH. PATIENT IS SCHEDULED FOR REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121824 ↗
• InjuryMar 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2021 DUE TO A FEMORAL STEM SUBSIDED. IT WAS REPLACED WITH A BIGGER IMPLANT. IMPLANTS REMOVED WERE R3 US DELTA HEAD 32 +4 AND POLARSTEM COLLAR STD. TI/HA 2. THERE ARE NO THOUGHTS FROM THE SURGEON THAT THE IMPLANT FAILED. HE BELIEVES IT WAS UNDERSIZED. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2019.

  Patient problems: Failure of Implant

  MAUDE report 11478943 ↗