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GMK Sphere Total Knee System 02.12.E0310CRRRecalls & reported problems

Medacta International SA · Tibial Insert Fixed SPHERE CR #3/10 mm R E-cross · Class 2 · Implant

All models of GMK Sphere Total Knee System (209)

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 07630971261501), received between Aug 17, 2022 and Aug 17, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Rupture” (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

  • Material Rupture1

Patient problems

  • Unspecified Tissue Injury1

Recent adverse event reports

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

  • InjuryAug 17, 2022Material Rupture

    AT 5 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A QUAD TENDON RUPTURE AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A QUAD TENDON REPAIR AND UPSIZED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 15240605 ↗

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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