DJO SURGICAL 400-03-442Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA, 44MM NEUTRAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888912076203), received between Dec 26, 2017 and Jan 14, 2026 — classified as 22 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 Problem13
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated3
- Unstable2
- Naturally Worn1
- No Apparent Adverse Event1
- Scratched Material1
Patient problems
- Unspecified Infection8
- Joint Dislocation6
- Joint Laxity3
- Insufficient Information2
- Failure of Implant1
- Medical device site infection1
- No Code Available1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION, POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 24077006 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CANCER PATIENT, INFECTED TWO MONTHS POST OP 60 YRS MALE.
Patient problems: Unspecified Infection
MAUDE report 23752404 ↗InjuryMay 5, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RIVISION SURGERY - DUE TO PATIENT RECENTLY FELL AND SUSTAINED A DISLOCATION OF THE HIP
Patient problems: Joint Dislocation
MAUDE report 19621234 ↗InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 23, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD STABILITY ISSUES.
Patient problems: Joint Laxity
MAUDE report 15620861 ↗InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT BECAME INFECTED AND REVISION SURGERY (ONE STAGE EXCHANGE WITH PRIMARY TO PRIMARY).
Patient problems: Medical device site infection
MAUDE report 15552686 ↗InjuryJun 6, 2022Device Dislodged or Dislocated
REVISION SURGERY - THE PATIENT IS AN ALCOHOLIC AND HAS EXPERIENCED 3-4 POST OPERATIVE DISLOCATIONS.
Patient problems: Joint Dislocation
MAUDE report 14605673 ↗InjuryJun 22, 2021Device Dislodged or Dislocated
REVSION SURGERY - PATIENT HAD BEEN DISLOCATING.
Patient problems: Insufficient Information
MAUDE report 12046964 ↗InjuryJun 8, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT DISLOCATED POST-OPERATIVELY DUE TO COMPLEX ANATOMY. THE SURGEON DID NOT INDICATE ANY INSUFFICIENCIES WITH THE PRODUCTS LISTED.
Patient problems: Joint Dislocation
MAUDE report 11961620 ↗InjuryFeb 2, 2021No Apparent Adverse Event
REVISION SURGERY - DUE TO UNKNOWN REASONS.
Patient problems: Insufficient Information
MAUDE report 11267003 ↗InjuryJan 8, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - INFECTION. JOINT WASH OUT WAS DONE.
Patient problems: Unspecified Infection
MAUDE report 11142660 ↗InjuryAug 21, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10436806 ↗InjuryJul 1, 2019Device Dislodged or Dislocated; Scratched Material
REVISION SURGERY - DUE TO PATIENT HAD DISLOCATION. THE HEAD WAS HEAVILY SCRATCHED FROM DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 8750209 ↗InjuryMar 12, 2018Naturally Worn
REVISION SURGERY - DUE TO THE PATIENT HAVING POLY WEAR. THE SURGEON REMOVED AND REPLACED THE HEAD. HE THEN CEMENTED IN A DUAL MOBILITY LINER INTO EXISTING CUP SO HE ONLY NEEDED THE HEAD.
Patient problems: Failure of Implant
MAUDE report 7332204 ↗InjuryDec 26, 2017Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT HAVING BAD BONE QUALITY. A 400-03-401 DJO HEAD WAS IMPLANTED IN THE REVISION AND THE SHELL AND LINER WERE REPLACED WITH ANOTHER BRAND AND NOT DJO.
Patient problems: No Code Available
MAUDE report 7145751 ↗
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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