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GMK Sphere Total Knee System 02.12.0420FLRecalls & reported problems

Medacta International SA · Tibial Insert Fixed SPHERE Flex #4/20 mm L · 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 07630030826696), received between Sep 25, 2020 and Sep 25, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

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.

  • InjurySep 25, 2020Insufficient Device Problem Information

    THE PATIENT CAME IN REPORTING INSTABILITY 2 YEARS AFTER THE PRIMARY SURGERY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON IMPLANTED A COMPETITOR BRACE AND REVISED THE MEDACTA GMK-SPHERE TIBIAL INSERT - FLEX S4L - 20 MM WITH A MEDACTA GMK-SPHERE TIBIAL INSERT - FLEX S4L - 20 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Joint Laxity

    MAUDE report 10585276 ↗

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

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Sources and updates

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