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DJO SURGICAL 385-15-504Recalls & reported problems

Encore Medical, L.P. · INSERT, STD., PRIMARY, SIZE4 15MM CM · Class 2 · 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 00888912117982), received between Dec 23, 2015 and Dec 23, 2015 — classified as 1 injury.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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

  • Material Too Rigid or Stiff1

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.

  • InjuryDec 23, 2015Material Too Rigid or Stiff

    REVISION SURGERY - DUE TO THE PATIENT HAVING STIFFNESS IN THEIR KNEE. THE SURGEON STATED THE POLY WAS TIGHT, SO HE REPLACED POLY.

    Patient problems: No Code Available

    MAUDE report 5324332 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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