DJO SURGICAL 400-04-280Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 28MM · 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 56 reports mostly describe hip joints dislocating or coming loose, along with infections that led to repeat revision surgery, plus one report of metal wear and a fractured pelvic bone socket. No deaths were reported, and all 56 reports involved injuries. 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
- 56
- Deaths reported
- 0
- Injuries reported
- 56
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00888912076234), received between Nov 15, 2017 and Dec 17, 2025 — classified as 56 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 Problem33
- Appropriate Device Problem Term/Code Not Available12
- Device Dislodged or Dislocated11
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Separation1
- Microbial Contamination of Device1
- Naturally Worn1
- Patient Device Interaction Problem1
Patient problems
- Joint Dislocation17
- Unspecified Infection11
- Insufficient Information10
- Joint Laxity4
- Failure of Implant3
- Fall3
- No Code Available3
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT HAS WAS POSITIVE FOR METALLOSIS, CUP LOOSENING AND FRACTURED ACETABULUM.
Patient problems: Bone Fracture(s); Joint Laxity; Metal Related Pathology
MAUDE report 23346940 ↗InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO IMPLANT FAILURE.
Patient problems: Failure of Implant
MAUDE report 21164337 ↗InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 20457795 ↗InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL.
Patient problems: Insufficient Information
MAUDE report 19640121 ↗InjuryMar 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FALL LOWER BODY COMPONENT.
Patient problems: Insufficient Information
MAUDE report 18718035 ↗InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - MDR - DISLOCATION - PATIENT DISLOCATED HIP FROM PREVIOUS REVISION SURGERY ON (B)(6). ORIGINALLY HAD A 28MM HEAD WITH NEUTRAL SLEEVE IMPLANTED SO DOCTOR REVISED TO A +7 SLEEVE FOR ADDED LEG LENGTH AND OFFSET FOR ADDED STABILITY.
Patient problems: Joint Dislocation
MAUDE report 18280055 ↗InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD A PRIMARY HIP, HAD PAIN AND ELEVATED LAB LEVEL'S SUSPICIOUS FOR INFECTION. THE SURGEON OPENED AND WASHED OUT THE WOUND AND SWAPPED THE POLY AND HEADBALL.
Patient problems: Medical device site infection; Pain
MAUDE report 18218196 ↗InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS INFECTED.
Patient problems: Medical device site infection
MAUDE report 18213145 ↗InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION & INSTABILITY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 17866046 ↗InjurySep 22, 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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