BIOLOX delta 76539161Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010566935), received between Nov 17, 2021 and Jan 14, 2026 — 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.

• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, PATIENT EXPERIENCED AN UNSPECIFIC ADVERSE EVENT. THEY DID A WASHOUT. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH, THE BIOLOX DELTA HEAD 32 MM 12/14 M / +4 & R3 36MM ID INTL DLT CER LNR 52MM WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information; Medical device site infection

  MAUDE report 24068060 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR WAS PERFORMED ON (B)(6) 2013 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED WITH A SMITH AND NEPHEW BEARING COMBINATION. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16051606 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, TWO WEEKS AFTER A REVISION THR SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PUS FROM THE WOUND. THE INFECTION WAS SOLVED VIA TWO-STAGE REVISION SURGERY, WHOSE FIRST LEG TOOK PLACE ON (B)(6) 2021. IMPLANTS WERE REMOVED WITHOUT ISSUE AND A CEMENT SPACER WAS IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Purulent Discharge

  MAUDE report 12829753 ↗

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.