DJO SURGICAL 400-03-404Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA, 40MM +8.0 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00888912023313), received between Apr 21, 2016 and Jul 27, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available8
- Adverse Event Without Identified Device or Use Problem6
- Device Dislodged or Dislocated6
- Unstable2
Patient problems
- Joint Dislocation6
- Unspecified Infection6
- Failure of Implant2
- Joint Laxity2
- No Code Available2
- Medical device site infection1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Unstable
InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 4, 2026Unstable
InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15745231 ↗InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT DISLOCATED AT THEIR REHAB FACILITY AND SURGEON WAS UNABLE TO DO A CLOSED REDUCTION.
Patient problems: Joint Dislocation
MAUDE report 15176678 ↗InjuryApr 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: PATIENT'S HIP DISLOCATED IMMEDIATELY POST-OPERATIVE. SURGEON DECIDED TO CONVERT TO A DUAL MOBILITY HEAD AND LINER FOR STABILITY.
Patient problems: Joint Dislocation
MAUDE report 14044067 ↗InjuryMar 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT HAD AN INFECTION, SURGEON REPLACED ALL OF THE METAL AND PLASTIC HE COULD WITHOUT CAUSING HARM TO THE PATIENT AND REPLACED WITH STERILE PARTS WITH THE SAME DIMENSIONS.
Patient problems: Unspecified Infection
MAUDE report 13684817 ↗InjuryMay 11, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - DISLOCATION AND INFECTION.
Patient problems: Unspecified Infection
MAUDE report 11807681 ↗InjuryDec 22, 2020Device Dislodged or Dislocated
REVISION SURGERY - PATIENT PRESENTED TO SURGEON WITH A DISLOCATED TOTAL HIP. SURGEON HAD TO PERFORM AND OPEN REDUCTION OF THE HIP UNDER ANESTHESIA. THE IMPLANT WAS REMOVED AND REPLACED WITH A 497-00-000 AND A 411-00-700 NECK SPACER.
Patient problems: Failure of Implant
MAUDE report 11059630 ↗InjuryOct 20, 2020Device Dislodged or Dislocated
InjuryOct 6, 2020Device Dislodged or Dislocated
InjurySep 23, 2020Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - PATIENT DEVELOPED A SURGICAL SITE INFECTION. AFTER A POLY EXCHANGE, PATIENT STILL REQUIRED REVISION DUE TO THE CONTINUED INFECTION. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED.
Patient problems: Unspecified Infection
MAUDE report 10574477 ↗InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT DEVELOPED A SURGICAL SITE INFECTION. HEAD EXCHANGE AND LINER EXCHANGE WERE PERFORMED.
Patient problems: Unspecified Infection
MAUDE report 10362038 ↗InjuryJul 14, 2020Appropriate Device Problem Term/Code Not Available
InjuryJun 26, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 10200852 ↗InjuryMar 20, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8438347 ↗InjuryNov 1, 2017Appropriate Device Problem Term/Code Not Available
FOURTH REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED.
Patient problems: Joint Dislocation
MAUDE report 6993431 ↗InjuryApr 21, 2016Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT'S HIP DISLOCATING.
Patient problems: No Code Available
MAUDE report 5595297 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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