DJO SURGICAL 400-03-443Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, CERAMIC, BILOX DELTA, 44MM +4.0 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912076210), received between Mar 13, 2017 and Mar 21, 2026 — classified as 14 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Aug 4, 2023Class IIOpen, Classified
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Z-2604-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available6
- Adverse Event Without Identified Device or Use Problem5
- Device Dislodged or Dislocated2
- Inadequacy of Device Shape and/or Size1
- Unstable1
Patient problems
- Unspecified Infection5
- Joint Dislocation3
- Extraskeletal ossification1
- Fall1
- Insufficient Information1
- Joint Laxity1
- No Code Available1
- No Information1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryMar 21, 2026Device Dislodged or Dislocated
REVISION SURGERY - DUE TO PATIENT HAD SEVERE FALL AND DISLOCATED AFTER PRIMARY LEFT TOTAL HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 24657091 ↗InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 7, 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
InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 23, 2022Appropriate Device Problem Term/Code Not Available
InjuryNov 29, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO HETEROTOPIC OSSIFICATION.
Patient problems: Extraskeletal ossification
MAUDE report 12882842 ↗InjuryJul 29, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT BECAME INFECTED AND SURGEON DECIDED TO DO A ONE STAGE REVISION ON.
Patient problems: Unspecified Infection
MAUDE report 12249861 ↗InjuryJun 2, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 11919116 ↗InjuryOct 8, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS BROUGHT IN FOR A WASHOUT AND HEAD EXCHANGE.
Patient problems: Insufficient Information
MAUDE report 10648935 ↗InjurySep 3, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - PATIENT HAD CHRONIC DISLOCATION. REMOVED AND EXCHANGED THE LINER AND HEAD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10488580 ↗InjurySep 4, 2018Unstable
InjuryMar 13, 2017Inadequacy of Device Shape and/or Size
REVISION SURGERY - DUE TO A LEG LENGTH INEQUALITY; THE SURGEON REMOVED AND REPLACED THE HEAD AND LINER.
Patient problems: No Code Available
MAUDE report 6400680 ↗
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 · each recall links to the FDA recall notice
- 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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