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GMK Sphere Total Knee System 02.12.0412CRLRecalls & reported problems

Medacta International SA · GMK Sphere CR Tibial Insert #4L 12mm · 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 07630040707510), received between Jan 22, 2020 and Jan 22, 2020 — 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

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryJan 22, 2020Appropriate Device Problem Term/Code Not Available

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT ON THE PATIENT AND DID NOT REMOVE OR REVISE ANY COMPONENTS. PRESENTLY, ON (B)(6)2019 (23 DAYS AFTER PRIMARY), THE PATIENT CAME IN DUE TO AN OPEN WOUND AND SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 9616220 ↗

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

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Sources and updates

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