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GMK Sphere Total Knee System 02.12.0112FLRecalls & reported problems

Medacta International SA · Tibial Insert Fixed SPHERE Flex #1/12 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 07630030825972), received between Dec 10, 2021 and Dec 10, 2021 — 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

  • Appropriate Device Problem Term/Code Not Available1

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.

  • InjuryDec 10, 2021Appropriate Device Problem Term/Code Not Available

    THE PATIENT CAME IN REPORTING INSTABILITY 5 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 12MM TO 20MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Joint Laxity

    MAUDE report 12974379 ↗

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

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Sources and updates

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