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SAIPH 193-802Recalls & reported problems

Matortho Ltd · SAIPH Fixed Tibial Bearing Green Right Size E 10mm · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055455507234), received between Nov 28, 2019 and Nov 28, 2019 — classified as 1 malfunction.

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 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Patient Problem/Medical Problem1

Recent adverse event reports

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

  • MalfunctionNov 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A NOTIFICATION WAS RECEIVED STATING "BOOKING FOR PATIENT NEEDING A CHANGE OF A E RIGHT FIXED TIBIAL BEARING 10MM DUE TO PATIENT'S RIGHT KNEE BEING UNSTABLE." (B)(4).

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 9390146 ↗

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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