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SAIPH 193-754Recalls & reported problems

Matortho Ltd · SAIPH Fixed Tibial Bearing Blue Right Size C 10mm · Class 2 · Implant

Data updated Oct 18, 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 05055455506756), received between Jul 10, 2019 and Jul 10, 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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionJul 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A NOTIFICATION WAS RECEIVED STATING THAT A LEFT TKR CASE WAS PERFORMED ON (B)(6) 2019 WHERE AN INCORRECT TIBIAL INSERT (RIGHT) WAS USED. ANOTHER SURGERY WAS PERFORMED ON (B)(6) 19 TO REMOVE THE INCORRECT TIBIAL INSERT IMPLANTED ON THE (B)(6) 2019 AND IMPLANT A CORRECT TIBIAL INSERT. (B)(4).

    Patient problems: No Information

    MAUDE report 8775643 ↗

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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