DJO SURGICAL 400-04-360Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 36MM · 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 replacement surgery. Across 46 reports since 2017, the most common story is the hip joint coming apart after implantation, along with infections and loosening of the implant that led patients to have revision surgery. There were 46 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
- 46
- Deaths reported
- 0
- Injuries reported
- 46
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00888912076258), received between Feb 21, 2017 and Jan 21, 2026 — classified as 46 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
- Appropriate Device Problem Term/Code Not Available15
- Adverse Event Without Identified Device or Use Problem14
- Device Dislodged or Dislocated14
- Insufficient Device Problem Information3
- Device Fell1
- Fitting Problem1
- Fracture1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Joint Dislocation16
- Unspecified Infection10
- Insufficient Information8
- No Code Available5
- Failure of Implant4
- Fall2
- No Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
InjuryJan 21, 2026Device Dislodged or Dislocated
InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 25, 2024Adverse 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
InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY. PATIENT WAS REVISED TO IMPLANTS WHICH CONSISTED OF AN ADJUSTMENT SLEEVE (+4 FROM -4) AND A 36MM BIOLOX DELTA OPTION HEAD. HE DISLOCATED ABOUT A WEEK AFTER THE SURGERY. HE WAS SCHEDULED FOR REVISION AND CONVERTED TO A DUAL MOBILITY CONSTRUCT.
Patient problems: Joint Dislocation
MAUDE report 15322169 ↗InjuryJun 14, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 14690258 ↗InjuryApr 11, 2022Device Dislodged or Dislocated
REVISION SURGERY: PATIENT WAS DISLOCATING HIP MULTIPLE TIMES, SURGEON PUT IN A DUAL MOBILITY IMPLANT.
Patient problems: Joint Dislocation
MAUDE report 14074330 ↗InjuryMar 21, 2022Appropriate Device Problem Term/Code Not Available
InjuryFeb 14, 2022Appropriate Device Problem Term/Code Not Available
InjuryDec 1, 2021Therapeutic or Diagnostic Output Failure
REVISION SURGERY - DUE TO FAILURE ACETABULAR SHELL.
Patient problems: Insufficient Information
MAUDE report 12913716 ↗InjuryNov 16, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO CUP WAS LOOSE. A NEW HEAD WAS USED AND A STRYKER CUP WAS PUT IN.
Patient problems: Insufficient Information
MAUDE report 12823876 ↗InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem
InjuryOct 12, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 12619009 ↗InjuryAug 31, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY, PATIENT HAD HIP INSTABILITY SO THE SURGEON REPLACED THE HEAD.
Patient problems: Insufficient Information
MAUDE report 12397425 ↗InjuryJul 8, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 12139548 ↗InjuryJul 1, 2021Insufficient Device Problem Information
InjuryApr 23, 2021Device Dislodged or Dislocated
REVISION SURGERY - PATIENT WAS DISLOCATING SO WE ADDED NECK LENGTH TO MAKE MORE STABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11716483 ↗InjuryApr 21, 2021Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 11704185 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page