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DJO SURGICAL 320-10-018Recalls & reported problems

Encore Medical, L.P. · FOUNDATION® KNEE SYSTEM Tibial Revision Stem · 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 00888912114455), received between Jun 2, 2021 and Jun 2, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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

  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryJun 2, 2021Tear, Rip or Hole in Device Packaging

    COMPLAINT: AFTER OPENING IMPLANT TO THE BACK TABLE, TECHNICIAN NOTICED HOLES IN THE PACKAGING. ITEM WAS NOT IMPLANTED BUT CROSSED THE STERILE FIELD.

    Patient problems: Insufficient Information

    MAUDE report 11919131 ↗

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

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Sources and updates

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