BIOLOX delta 76539167Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010566973), received between Dec 29, 2017 and Sep 27, 2021 — classified as 3 injuries.

1 other recall cover devices cleared under the same FDA submission (K083762, K211176); they may or may not involve this specific model.

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

• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2018, THE PATIENT PRESENTED TO HOSPITAL WITH A SIGNIFICANT INFECTION AND AN ABSCESS OF HIS RIGHT HIP EXTENDING DISTALLY TO APPROXIMATELY 10CM PROXIMAL TO THE KNEE. THIS ADVERSE SITUATION WAS TREATED WITH A REVISION SURGERY PERFORMED ON (B)(6) 2021, WHERE THE REDAPT 300MM SLEEVED REVISION STEM SIZE 13 HIGH OFFSET, THE REDAPT MODULAR SLEEVE MEDIUM SIZE 12-13 STIKTITE WITH HYDROXYAPATITE AND THE BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8 WERE REMOVED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 12537718 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT HAD INITIAL THR PROCEDURE PERFORMED ON (B)(6) OF 2020. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2020, FOR THE CERAMIC LINER AND THE CERAMIC HEAD OF THE ACETABULUM, BECAUSE THE PATIENT KEEPS DISLOCATING. NO INJURY OR DIVERSE EFFECTS DUE TO PROSTHESES. PATIENT HAD A FALL AND DISLOCATION IN HOSPITAL RECOVERING FROM FIRST SURGERY. THIS WAS SUCCESSFULLY REDUCED.

  Patient problems: Joint Dislocation

  MAUDE report 11152666 ↗
• InjuryDec 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT HIP REVISION SURGERY DUE TO INSTABILITY. ACETABULAR LINER AND FEMORAL HEAD WERE REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 7154030 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083762, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.