DJO SURGICAL 400-03-402Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA, 40MM NEUTRAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO ceramic hip femoral head is an implant used in hip replacement surgery. Its 88 reports mostly describe dislocations and infections, many requiring revision surgery. All 88 are injury reports, and no deaths are listed. 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
- 89
- Deaths reported
- 0
- Injuries reported
- 89
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00888912023306), received between Feb 25, 2016 and Sep 15, 2026 — classified as 89 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 Problem48
- Appropriate Device Problem Term/Code Not Available23
- Device Dislodged or Dislocated14
- Insufficient Device Problem Information2
- Loose or Intermittent Connection2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Unstable2
- Inadequacy of Device Shape and/or Size1
Patient problems
- Unspecified Infection37
- Joint Dislocation26
- Joint Laxity8
- Insufficient Information7
- No Code Available6
- Failure of Implant5
- Fall5
- Bone Fracture(s)2
Recent adverse event reports
The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Loosening of Implant Not Related to Bone-Ingrowth
Revision surgery - Due to Fall Lower Body / Loosening.
Patient problems: Fall; Joint Laxity
MAUDE report 50766720 ↗InjuryJul 29, 2026Device Dislodged or Dislocated
InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAD SEVERAL DISLOCATIONS AFTER PRIMARY RIGHT TOTAL HIP. REQUIRED REVISION OF POLY LINER BY PLACING HOODED PORTION ANTERIORLY AND IMPLANTING AN UPSIZED FEMORAL HEAD FROM A 40X0 TO A 40X+4 COCR HEAD.
Patient problems: Joint Dislocation
MAUDE report 24622304 ↗InjuryMar 13, 2026Unstable
InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
PATIENT SUFFERED AN INFECTION IN HIS HIP, ALL COMPONENTS WERE REMOVED FROM ORIGINAL SURGERY AND AFTER AN ANTIBIOTIC SPACER, WE REIMPLANTED 69 YRS MALE.
Patient problems: Unspecified Infection
MAUDE report 24562435 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 9, 2026Device Dislodged or Dislocated
InjuryDec 3, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 2, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND INFECTION.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 22852993 ↗InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAD A VERY BAD FALL AT PT AND FRACTURE HERE FEMUR TWO MONTHS AFTER PRIMARY LEFT TOTAL HIP.
Patient problems: Bone Fracture(s); Fall
MAUDE report 22181160 ↗InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 31, 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
InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 24, 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
REVISION SURGERY - DUE TO SUSPECTED INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20024984 ↗InjuryAug 15, 2024Adverse 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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