Biolox Delta Modular Head 36mm LONG +4.0mm 12/14 Eurocone Taper 104.3610Recalls & reported problems
Corin Ltd · BIOLOX Delta Ceramic Head · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05055196964396), received between Aug 27, 2025 and Sep 29, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Loss of Osseointegration1
Patient problems
- Pain2
- Unspecified Infection2
- Joint Dislocation1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50927752 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
TRINITY REVISION OF THE BIOLOX DELTA CERAMIC HEAD AFTER 1 MONTH DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24322615 ↗InjuryDec 22, 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 1 WEEK DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23861653 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TRINITY REVISION OF THE BIOLOX DELTA CERAMIC HEAD DUE TO PAIN AFTER APPROXIMATELY 2 YEARS AND 7 MONTHS. IT WAS BELIEVED THAT THE METAFIX STEM WAS LOOSE AND THUS A REVISION SCHEDULED. STEM WAS NOT IDENTIFIED AS LOOSE INTRA-OP AT THE REVISION AND THUS THE HEAD WAS CHANGED AND PATIENT CLOSED.
Patient problems: Pain
MAUDE report 23083532 ↗InjuryAug 27, 2025Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information
TRINITY REVISION OF THE HEAD AND LINER AFTER APPROXIMATIVELY 9 YEARS AND 8 MONTHS DUE TO DISLOCATION. NOTE: THE TRINITY LINER 321.04.436 IS NOT CLEARED IN THE USA.
Patient problems: Joint Dislocation
MAUDE report 22904123 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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