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SAIPH 193-030Recalls & reported problems

Matortho Ltd · SAIPH Femur Cemented Blue Right Size 6 · 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 05055455506121), received between Oct 3, 2019 and Oct 3, 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

  • No Information1

Recent adverse event reports

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

  • MalfunctionOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    "PATIENT SPECIFIC MOULD FOR THE FEM HAD THE DISTAL BLOCK PIN HOLES IN THE WRONG POSITION CAUSING THE REST OF THE CUTTING BLOCKS TO BE MALPOSITIONED. FEM WAS RECUT TO COUNTER THE MALPOSITIONING BUT THE RESULT WAS NOT IDEAL." (B)(4).

    Patient problems: No Information

    MAUDE report 9150060 ↗

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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