DJO SURGICAL 400-03-322Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA, 32MM NEUTRAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical ceramic femoral head is part of a hip replacement. Reports mostly describe hip dislocations and infections that led to revision surgery, along with some falls and fractures. There are 41 adverse event reports naming its identifier: no deaths and 41 injuries. No recalls name 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
- 41
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00888912076098), received between Dec 22, 2015 and Sep 20, 2024 — classified as 41 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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
- Appropriate Device Problem Term/Code Not Available15
- Adverse Event Without Identified Device or Use Problem14
- Device Dislodged or Dislocated11
- Unstable3
- Inadequacy of Device Shape and/or Size1
- Insufficient Device Problem Information1
Patient problems
- Joint Dislocation13
- Unspecified Infection10
- No Code Available9
- Insufficient Information4
- No Known Impact Or Consequence To Patient3
- Fall2
- Hip Fracture1
- Implant Pain1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND INFECTION.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 20274340 ↗InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL 3 WEEKS AFTER SURGERY AND BROKE HER GREATER TROCHANTER OFF. HIP WAS STABLE BUT DR DECIDED TO LENGTHEN HIP WHILE WE WERE IN THERE.
Patient problems: Joint Laxity; Muscle/Tendon Damage
MAUDE report 19029773 ↗InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DR. COMPLETED ACETABULAR REVISION OF STRYKER CUP & REMOVED 32 HEAD & IMPLANTED NEW 32 HEAD ON TAPERFILL STEM.
Patient problems: Insufficient Information
MAUDE report 18744670 ↗InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - FALL LOWER BODY COMPONENT/DISLOCATION/FRACTURE.
Patient problems: Hip Fracture; Joint Dislocation
MAUDE report 16143260 ↗InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT PRESENTED WITH A HIP DISLOCATION. THE HIP WAS REVISED. THE 32MM NEUTRAL HEAD WAS CHANGED TO A +7MM DUAL MOBILITY CONSTRUCT.
Patient problems: Joint Dislocation
MAUDE report 15218411 ↗InjuryMay 19, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14436761 ↗InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem
InjuryFeb 25, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO A HIP DISLOCATION AFTER A FALL.
Patient problems: Fall; Joint Dislocation
MAUDE report 13602591 ↗InjuryFeb 24, 2022Appropriate Device Problem Term/Code Not Available
InjuryDec 10, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 12976167 ↗InjuryOct 12, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS NON COMPLIANT AND DISLOCATED.
Patient problems: Insufficient Information
MAUDE report 12618981 ↗InjuryAug 12, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION, HEAD AND LINER EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 12316689 ↗InjuryJun 29, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT INFECTED, PERFORMED IRRIGATION & DRAINAGE WASHOUT AND CHANGED HEAD.
Patient problems: Insufficient Information
MAUDE report 12088870 ↗InjuryApr 22, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SUPERFICIAL INFECTION OF SURGICAL SITE FOLLOWING PRIMARY TOTAL HIP ARTHROPLASTY INDICATED IRRIGATION AND DEBRIDEMENT OF THE WOUND. HIP JOINT AND REPLACEMENT OF BEARING SURFACE COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 11711569 ↗InjuryJan 11, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS BROUGHT BACK TO THE OR FOR DISLOCATION OF THE HIP. SURGEON CHANGED OUT FEMORAL HEAD AND PROXIMAL BODY DURING THE PROCEDURE.
Patient problems: Joint Dislocation
MAUDE report 11149898 ↗InjuryJan 9, 2021Appropriate Device Problem Term/Code Not Available
InjuryNov 19, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT FELL AND DISLOCATED. SURGEON CHANGED FROM A +0 WITH A ZERO OFFSET NON HOODED TO A +4 HEAD WITH A ZERO OFFSET 10 DEGREE HOOD.
Patient problems: Fall; Joint Dislocation
MAUDE report 10872497 ↗InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10815855 ↗InjuryApr 17, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT DISLOCATED. SHE WAS IN NEED OF A CONSTRAINED LINER.
Patient problems: Joint Dislocation
MAUDE report 9973165 ↗InjuryMar 24, 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 9873419 ↗InjuryMar 3, 2020Device Dislodged or Dislocated
REVISION SURGERY - PATIENT KEPT DISLOCATING.
Patient problems: No Code Available
MAUDE report 9779830 ↗InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT DISLOCATED POST-OPERATION. PATIENT WAS IN NEED OF A CONSTRAINED LINER.
Patient problems: Joint Dislocation
MAUDE report 9268821 ↗
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