Biolox Delta Modular Head 40mm EXTRA LONG +8.0mm 12/14 Eurocone Taper 104.4015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055196926998), received between May 29, 2025 and Apr 16, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K130343); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  TRINITY REVISION (OPS USED IN PRIMARY) OF THE BIOLOX DELTA CERAMIC HEAD AFTER APPROXIMATELY 2 YEARS AND 6 MONTHS DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 24902860 ↗
• InjuryMay 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  TRINITY REVISION OF THE SHELL, BIOLOX DELTA CERAMIC HEAD AND BIOLOX DELTA CERAMIC LINER AFTER APPROXIMATIVELY 12 YEARS DUE TO REPORTED EDGE LOADING OF THE CERAMIC LINER PLEASE NOTE: THE TRINITY BIOLOX DELTA CERAMIC LINER SUBJECT OF THIS REPORT IS NOT CLEARED FOR SALE OR DISTRIBUTION IN THE USA AND THIS EVENT OCCURRED OUTSIDE OF THE USA. A BIOLOX DELTA CERAMIC HEAD WAS ALSO REVISED, THIS DEVICE IS CLEARED FOR SALE /DISTRIBUTION IN THE USA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103400 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130343. One submission often covers many models, so check the product and lot details in each record.

• Z-1291-2021 · Jan 25, 2021 · Terminated
  Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis).
• Z-1290-2021 · Jan 25, 2021 · Terminated
  Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis).