DJO SURGICAL 400-03-364Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA, 36MM +8.0 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a ceramic femoral head, the ball-shaped top of an artificial hip joint made by Encore Medical. The 32 reports mostly describe the hip joint dislocating and infections, plus a few describing the ceramic head fracturing. All 32 involved injuries and no deaths were reported. Most describe revision surgery to fix the problem, and several mention falls as what set the dislocation off. 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
- 32
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00888912076159), received between Sep 16, 2015 and Aug 23, 2025 — classified as 32 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 Problem12
- Appropriate Device Problem Term/Code Not Available7
- Device Dislodged or Dislocated7
- Fracture3
- Insufficient Device Problem Information3
- Unstable2
- Loose or Intermittent Connection1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Joint Dislocation7
- Unspecified Infection7
- No Code Available6
- Fall3
- Pain3
- Discomfort2
- No Known Impact Or Consequence To Patient2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2025Adverse 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 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO CHRONIC DISLOCATION FROM FALLS.
Patient problems: Joint Dislocation
MAUDE report 20131623 ↗InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 16, 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
InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14575297 ↗InjuryMar 15, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 13775085 ↗InjuryNov 13, 2020Appropriate Device Problem Term/Code Not Available
InjuryAug 24, 2020Unstable
REVISION SURGERY - ACETABULAR CUP WAS UNSTABLE AND NEEDED TO BE REPLACED.
Patient problems: No Code Available
MAUDE report 10442756 ↗InjuryJul 21, 2020Device Dislodged or Dislocated
REVISION SURGERY - THE PATIENT WAS DISLOCATED SO SURGEON PUT IN A CONSTRAINED LINER WHICH CHANGED THE HEAD TO A MINUS 32 HEAD.
Patient problems: No Code Available
MAUDE report 10301801 ↗InjuryJul 15, 2020Loosening of Implant Not Related to Bone-Ingrowth
InjuryJun 17, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT DISLOCATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10163147 ↗InjuryMar 6, 2020Unstable
InjuryJan 8, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DISLOCATED POST-OPERATION.
Patient problems: Joint Dislocation
MAUDE report 9564400 ↗InjuryDec 18, 2019Fracture
REVISION SURGERY - DUE TO FRACTURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9490692 ↗InjuryNov 12, 2019Appropriate Device Problem Term/Code Not Available
InjuryJun 6, 2019Device Dislodged or Dislocated
REVISION SURGERY - PATIENT HAD HIP DISLOCATION.
Patient problems: No Information
MAUDE report 8675207 ↗InjuryMay 23, 2019Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 8636721 ↗InjuryMay 1, 2019Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT FALLING AND FRACTURING THEIR HIP.
Patient problems: Fall
MAUDE report 8570322 ↗InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT FALLING AND HAVING A FRACTURE.
Patient problems: Bone Fracture(s); Fall
MAUDE report 7853204 ↗
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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