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P.F.C. 98-6081Recalls & reported problems

Depuy Orthopaedics, Inc. · P.F.C. STABILIZED TIBIAL INSERT 5 10.0mm · 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 10603295253433), received between Jun 21, 2022 and Jun 21, 2022 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT WAS INFECTED. REMOVED ALL COMPONENTS AND PUT IN ANTIBIOTIC SPACER. NO INFO ON ORIGINAL OR DATE OR PART NUMBERS OF OTHER COMPONENTS. PATIENT HAD I&D POLY EXCHANGE ON 10-11-19. DOI: OCTOBER 11,2019. DOR: JUNE 6,2022. AFFECTED SIDE: RIGHT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 14753470 ↗

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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