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DJO SURGICAL 400-01-295Recalls & reported problems

Encore Medical, L.P. · Ceramic Head -4.0 - Size 32 · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912075701), received between Sep 20, 2016 and Sep 20, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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.

Most reported problems

Device problems

  • Device Operates Differently Than Expected1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 20, 2016Device Operates Differently Than Expected

    REVISION SURGERY - THE TOTAL HIP IMPLANT FAILED; REQUIRING THIS REVISION OF A TOTAL HIP.

    Patient problems: No Code Available

    MAUDE report 5963063 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented devices →

Sources and updates

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