DJO SURGICAL 400-04-320Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 32MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888912076241), received between Feb 9, 2018 and Aug 28, 2025 — classified as 16 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 Problem8
- Device Dislodged or Dislocated4
- Appropriate Device Problem Term/Code Not Available3
- Patient-Device Incompatibility1
- Unstable1
Patient problems
- Joint Dislocation6
- No Code Available2
- No Known Impact Or Consequence To Patient2
- Unspecified Infection2
- Implant Pain1
- Medical device site infection1
- No Clinical Signs, Symptoms or Conditions1
- Post Operative Wound Infection1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - HIP WASHOUT, IMPLANTS REMOVED, NEW IMPLANTS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15820678 ↗InjuryOct 10, 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 15572563 ↗InjuryJul 6, 2021Appropriate Device Problem Term/Code Not Available
THIRD REVISION SURGERY - SURGEON SAW THIS PATIENT FOLLOWING A DISLOCATION OF HER LEFT HIP. THIS WAS HER 3RD TIME DISLOCATING THAT HIP. SURGEON CHOSE TO REVISE HER IN AN EFFORT TO MAKE HER MORE STABLE. HE REMOVED THE IMPLANTS, LATERALIZED HER THEN USED A ZIMMER DUAL MOBILITY CUP AND LINER FOE ADDED STABILITY.
Patient problems: Joint Dislocation
MAUDE report 12125469 ↗InjuryFeb 22, 2021Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 11357790 ↗InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REASONS.
Patient problems: No Code Available
MAUDE report 10048899 ↗InjuryFeb 27, 2020Device Dislodged or Dislocated
SECOND REVISION SURGERY - PATIENT HAD DISLOCATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9764213 ↗InjuryOct 10, 2019Appropriate Device Problem Term/Code Not Available
InjuryJul 5, 2019Device Dislodged or Dislocated
SECOND REVISION SURGERY - AFTER INITIAL REVISION SURGERY TO ADD GREATER NECK LENGTH, PATIENT CONTINUED TO DISLOCATE. THE SURGEON WENT IN TO REVISE THE PROTHESIS TO CREATE MORE STABILITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8765398 ↗InjuryJun 25, 2019Appropriate Device Problem Term/Code Not Available
InjuryMar 30, 2018Patient-Device Incompatibility
SECOND REVISION SURGERY - DUE TO THE HIP BEING REVISED FOR AN IRRIGATION AND DEBRIDEMENT. THE SURGEON CHANGED THE HEAD AND SLEEVE.
Patient problems: Post Operative Wound Infection
MAUDE report 7386040 ↗InjuryFeb 9, 2018Unstable; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT DISLOCATING AND BEING UNSTABLE.
Patient problems: No Code Available
MAUDE report 7260068 ↗
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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