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Remedy Spacer RSKTLGRecalls & reported problems

Osteoremedies, LLC · REMEDY® Stemmed Tibial Component LG · Class 2

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 00855195006685), received between Feb 17, 2021 and Feb 17, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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

  • Break1

Patient problems

  • Failure of Implant1
  • Limited Mobility Of The Implanted Joint1

Recent adverse event reports

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

  • InjuryFeb 17, 2021Break; Break

    ONE MONTH POST-OPERATIVE THE PATIENT WAS WALKING FULL WEIGHT BEARING AND FRACTURED THE TIBIAL KNEE COMPONENT. THE SURGEON REVISED THE KNEE TO REMOVE THE BROKEN SPACER AND REPLACE IT WITH A METAL TIBIAL AND FEMUR STATIC SPACER.

    Patient problems: Failure of Implant; Limited Mobility Of The Implanted Joint

    MAUDE report 11340270 ↗

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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