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SAIPH 193-749Recalls & reported problems

Matortho Ltd · SAIPH Fixed Tibial Bearing Blue Left Size C 12mm · 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 05055455506701), received between Jan 16, 2020 and Jan 16, 2020 — 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

  • Joint Disorder1
  • 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.

  • MalfunctionJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    "2ND REVISION CASE WAS DONE BY MR (B)(6) AT (B)(6) PRIVATE HOSPITAL (B)(6) ON WEDNESDAY, (B)(6) 2019 AND POLY WAS REPLACED. 1ST REVISION WAS DONE BY MR (B)(6) ON (B)(6) 2019 AND PATELLA WAS REPLACED." MATORTHO REFERENCE (B)(4).

    Patient problems: Joint Disorder; Patient Problem/Medical Problem

    MAUDE report 9595656 ↗

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

How reports and recalls are matched · Editorial policy · Report an error on this page