Biolox Delta Modular Head 28mm MEDUM 0.0mm 12/14 Eurocone Taper 104.2805Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05055196964327), received between Jul 1, 2025 and Sep 29, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Device Dislodged or Dislocated

  Trinity Dual Mobility and Biolox Delta revision (OPS used in primary) of the head and insert after approximatively 2 weeks due to dislocation (following a fall).

  Patient problems: Joint Dislocation

  MAUDE report 50927730 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Paragon / Trinity Dual Mobility revision (with OPS used in primary) of the Stem, ECiMa Insert and BIOLOX Delta Ceramic Head after nearly 3 months due to a leg length discreapancy following a femoral fracture (with Stem subsidence) and previous surgery to plate and cable the femur. Please note: the Paragon Stem associated with this report (GM08001-202-05) is not cleared for sale / distribution in the USA and this event occurred outside of the USA.

  Patient problems: Bone Fracture(s); Unequal Limb Length

  MAUDE report 50800458 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  TRINITY DUAL MOBILITY REVISION OF THE BIOLOX DELTA CERAMIC HEAD AND ECIMA INSERT ON THE SAME DAY AS PRIMARY SURGERY DUE TO BONE FRACTURE WHICH WAS SUSTAINED IN SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23825311 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  TRINITY DUAL MOBILITY REVISION OF THE ECIMA INSERT AND BIOLOX DELTA CERAMIC HEAD AFTER APPROXIMATELY 7 MONTHS DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 22911225 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRINITY REVISION OF THE BIOLOX DELTA CERAMIC HEAD AFTER APPROXIMATELY 1 MONTH AND 2 WEEKS DUE TO SYMPTOMS OF INFECTION. THE REPORTER HAS STATED THAT NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22369706 ↗