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GMK Sphere Total Knee System 02.12.0320FRRecalls & reported problems

Medacta International SA · Tibial Insert Fixed SPHERE Flex #3/20 mm R · 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 07630030826504), received between Feb 13, 2023 and Feb 13, 2023 — classified as 1 injury.

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 Laxity1

Recent adverse event reports

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

  • InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AT ABOUT 8 MONTHS AFTER THE PRIMARY KNEE SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON REVISED FEMUR AND LINER (20 TO 26 MM) AND DECIDED TO CONVERT THE PATIENT TO A SEMI-CONSTRAINED CONSTRUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Joint Laxity

    MAUDE report 16362565 ↗

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

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Sources and updates

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