DJO SURGICAL 400-03-323Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA, 32MM +4.0 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888912076104), received between Sep 29, 2015 and Dec 19, 2025 — classified as 17 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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
- Device Dislodged or Dislocated8
- Appropriate Device Problem Term/Code Not Available6
- Adverse Event Without Identified Device or Use Problem4
- Unstable3
- Insufficient Device Problem Information2
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Unspecified Infection6
- No Known Impact Or Consequence To Patient4
- Joint Dislocation3
- No Code Available2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fall1
- Joint Laxity1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 28, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 24, 2021Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PATIENT DISLOCATED. SURGEON FOUND OUT THAT SCREW/BOLT ON THE PROXIMAL BODY WAS LOOSE.
Patient problems: Joint Dislocation
MAUDE report 12525786 ↗InjuryJul 14, 2021Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL AND WAS UNSTABLE & INFECTED. REMOVED 32 +4 HEAD.
Patient problems: Fall; Unspecified Infection
MAUDE report 12170152 ↗InjuryNov 23, 2020Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10884814 ↗InjuryAug 10, 2020Unstable
InjuryJul 28, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD DISLOCATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10332159 ↗InjuryJun 30, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT DISLOCATED ANTERIORLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10212132 ↗InjuryJun 29, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
InjuryMay 23, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8637420 ↗InjuryAug 31, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7839726 ↗InjuryAug 10, 2018Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE STEM HAVING SUBSIDED AND PUTTING A LONG OFFSET NECK IN PATIENT.
Patient problems: No Code Available
MAUDE report 7772236 ↗InjuryJan 17, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION. THE SURGEON REMOVED THE LINER, HEAD AND STEM IN ORDER TO DO A SINGLE STAGE IRRIGATION AND DRAINAGE WASHOUT OF THE JOINT.
Patient problems: Unspecified Infection
MAUDE report 7200849 ↗InjuryFeb 6, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT DISLOCATING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6304145 ↗InjuryJan 14, 2016Device Dislodged or Dislocated
REVISION SURGERY, DUE TO THE PATIENT DISLOCATING THEIR HIP.
Patient problems: Joint Dislocation
MAUDE report 5367095 ↗InjurySep 29, 2015Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 5111660 ↗
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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