DJO SURGICAL 400-03-281Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA, 28MM -3.5 · 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. Most of the 57 reports describe the hip coming apart after implantation — the joint dislocating or loosening, and repeated infection that led to revision surgery. No deaths were reported, but 57 injuries were. There are no recalls naming 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
- 59
- Deaths reported
- 0
- Injuries reported
- 59
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00888912076050), received between Sep 16, 2016 and Sep 28, 2026 — classified as 59 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 Problem41
- Device Dislodged or Dislocated7
- Appropriate Device Problem Term/Code Not Available5
- Unstable4
- Insufficient Device Problem Information2
- Inadequacy of Device Shape and/or Size1
- Material Separation1
- Microbial Contamination of Device1
Patient problems
- Unspecified Infection22
- Joint Dislocation17
- Joint Laxity6
- No Code Available6
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Failure of Implant2
- Arthralgia1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Dislocation
MAUDE report 50926088 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
Revision Surgery - Due to Patient fell post operatively and had a periprosthetic fracture on her femur.
Patient problems: Fall
MAUDE report 50358141 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFECTION - WASHOUT HEMI, BI-POLAR HEAD EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 23824453 ↗InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 15, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT'S FEMORAL HEAD DISLOCATED FROM THE ACETABULAR CUP AND CONSTRAINED LINER, AND THAT THE PROXIMAL BODY WAS REPLACED WITH A LARGER SIZE TO INCREASE THE STABILITY OF THE FEMORAL HEAD.
Patient problems: Joint Dislocation
MAUDE report 23297674 ↗InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 15, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 11, 2024Unstable; Unstable
REVISION SURGERY DUE TO DISLOCATION AND INSTABILITY.
Patient problems: Joint Dislocation
MAUDE report 20909613 ↗InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT COMPLAINED OF HIP PAIN.
Patient problems: Implant Pain
MAUDE report 20660026 ↗InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 18, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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