DJO SURGICAL 400-04-400Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 40MM · Class 2 · Implant
Data updated Oct 18, 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 00888912076265), received between Apr 6, 2016 and Mar 16, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Problem9
- Appropriate Device Problem Term/Code Not Available7
- Device Dislodged or Dislocated4
- Contamination1
- Loose or Intermittent Connection1
- Unstable1
Patient problems
- Unspecified Infection7
- Joint Dislocation5
- Insufficient Information3
- Joint Laxity2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
- Medical device site infection1
- No Code Available1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 5, 2026Unstable
InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DEHISING, SWAPPED HEAD AND LINER , UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 23022868 ↗InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 28, 2024Adverse 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 19001084 ↗InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO CHRONIC INFECTION.
Patient problems: Medical device site infection
MAUDE report 15865057 ↗InjuryMay 19, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY :PATIENT WAS SITTING IN LOUNGE CHAIR AND DISLOCATED HIP.
Patient problems: Insufficient Information
MAUDE report 14436505 ↗InjuryMay 12, 2022Appropriate Device Problem Term/Code Not Available
InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem
InjuryJan 19, 2022Device Dislodged or Dislocated
REVISION SURGERY: PATIENT DISLOCATED HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13290332 ↗InjuryJan 11, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD DRAINAGE AND POTENTIAL EARLY SIGNS OF INFECTION. SURGEON JUST DID A WASHOUT AND HEAD EXCHANGE. USED SAME SIZE HEAD, NO DJO ISSUE, JUST PROACTIVE MEASURE TO PREVENT INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13231793 ↗InjuryApr 15, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - POSTERIOR DISLOCATION.
Patient problems: Failure of Implant
MAUDE report 11671339 ↗InjuryNov 13, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - PATIENT'S CUP WAS LOOSENING. REMOVED THE HEAD, SLEEVE AND CUP. DJO REPLACED THE HEAD AND SLEEVE WITH OUR PRODUCT. CUP WAS REPLACED WITH ANOTHER COMPANY.
Patient problems: Insufficient Information
MAUDE report 10836330 ↗InjuryJul 28, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10332154 ↗InjuryMar 13, 2020Device Dislodged or Dislocated
InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - HIP DISLOCATION. CUP NEEDED TO BE REPLACED.
Patient problems: Joint Dislocation
MAUDE report 9099476 ↗InjuryApr 8, 2019Appropriate Device Problem Term/Code Not Available
FOURTH REVISION SURGERY - DUE TO AN INFECTION. THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT.
Patient problems: Unspecified Infection
MAUDE report 8493567 ↗InjuryDec 19, 2016Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6185741 ↗InjuryApr 6, 2016Contamination
SECOND REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; THE SURGEON SWAPPED OUT THE HEAD AND LINER. (B)(6).
Patient problems: Unspecified Infection
MAUDE report 5551166 ↗
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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