DJO SURGICAL 400-03-403Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA, 40MM +4.0 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a ceramic femoral head used in hip replacements. The 60 reports mostly describe patients who needed revision surgery, most often because of infection, along with joint dislocation, joint laxity and pain. All 60 report injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 60
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00888912076180), received between Dec 5, 2017 and Mar 9, 2026 — classified as 60 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 reports).
1 other recall cover devices cleared under the same FDA submission (K082844); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem37
- Appropriate Device Problem Term/Code Not Available16
- Device Dislodged or Dislocated7
- Unstable2
- Insufficient Device Problem Information1
- Output Problem1
Patient problems
- Unspecified Infection30
- Joint Dislocation11
- Insufficient Information5
- Joint Laxity5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Failure of Implant3
- Implant Pain3
- Pain2
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem
InjuryOct 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S REQUIRED REVISION SURGERY DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23333906 ↗InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 8, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - WOUND NOT CLOSING WELL WASH OUT WITH POLY AND HEAD.
Patient problems: Insufficient Information
MAUDE report 18576962 ↗InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Implant Pain; Joint Dislocation
MAUDE report 17733802 ↗InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - SERIOUS RISK TO PATIENT/REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.
Patient problems: Bursitis
MAUDE report 17206001 ↗InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 16792182 ↗InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Recalls under the same FDA submission
These recalls involve devices cleared under K082844. One submission often covers many models, so check the product and lot details in each record.
- Z-2604-2023 · Aug 4, 2023 · Open, ClassifiedDJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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