DJO SURGICAL 400-03-401Recalls & 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 DJO Surgical ceramic hip replacement head. The 47 reports describe hip implants coming loose or dislocating, along with infections, and many patients needing revision surgery; no deaths were reported and all 47 reports involved injuries. There are no recalls naming this device, and the number of reports is steady at 4 in each of the last two 12-month periods.
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
- 47
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00888912076166), received between Nov 30, 2016 and Apr 6, 2026 — classified as 47 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 Problem22
- Appropriate Device Problem Term/Code Not Available11
- Device Dislodged or Dislocated10
- Unstable3
- Contamination1
- Device Slipped1
- Inadequacy of Device Shape and/or Size1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Unspecified Infection23
- Joint Dislocation6
- No Code Available6
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Joint Laxity2
- No Known Impact Or Consequence To Patient2
- Bacterial Infection1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
InjuryApr 6, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAD GROIN PAIN. EXPLORATION. HEAD AND POLY SWAP.
Patient problems: Pain
MAUDE report 23986245 ↗InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 18, 2024No Apparent Adverse Event; No Apparent Adverse Event
InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 15, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 18145736 ↗InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD AN INFECTION IN THE INCISION. HEAD WAS SWAPPED OUT AN A WASHOUT WAS DONE.
Patient problems: Medical device site infection
MAUDE report 15674906 ↗InjuryAug 11, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS INFECTED REMOVED EVERYTHING AND RE-IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 15210940 ↗InjuryFeb 9, 2022Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 13499712 ↗InjuryJan 4, 2022Appropriate Device Problem Term/Code Not Available
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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