DJO SURGICAL 400-01-290Recalls & reported problems
Encore Medical, L.P. · Ceramic Femoral Head -3.5 - Size 28 · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912075664), received between Dec 12, 2018 and May 27, 2025 — classified as 3 injuries.
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 Available2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Joint Dislocation1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 5, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PRODUCT HAS BEEN IN FOR NEARLY 20 YEARS. SURGEON WANTED TO REVISE TO A DUAL MOBILITY HIP TO PROVIDE MORE STABILITY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11614877 ↗InjuryDec 12, 2018Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - DUE TO THE PATIENT HAVING LACK OF MOTION AND HIP PAIN. THE SURGEON DECIDED TO REVISE THE CUP AND SWAP OUT THE HEAD.
Patient problems: Pain
MAUDE report 8157827 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented devices
- BIOLOX DELTA 1365-36-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented839 reports
- BIOLOX DELTA 1365-36-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented643 reports
- PINNACLE POROCOAT 1217-22-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented335 reports
- PINNACLE POROCOAT 1217-22-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented263 reports
- BIOLOX DELTA 1365-36-330Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented255 reports
- PINNACLE POROCOAT 1217-22-050Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented253 reports
- PINNACLE POROCOAT 1217-22-056Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented220 reports
- SUMMIT POROCOAT 1570-11-120Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 death204 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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