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GMK Sphere Total Knee System 02.12.E0417FRRecalls & reported problems

Medacta International SA · Tibial Insert Fixed SPHERE FLEX #4/17 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 07630971261945), received between Jun 13, 2023 and Jun 13, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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

  • Device Appears to Trigger Rejection1

Patient problems

  • Medical device site infection1

Recent adverse event reports

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

  • InjuryJun 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    AT ABOUT 5 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Medical device site infection

    MAUDE report 17117864 ↗

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

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Sources and updates

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