GMK Sphere Total Knee System 02.12.E0313FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971261648), received between Jun 6, 2025 and Nov 18, 2025 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRIMARY KNEE SURGERY USING A COMPETITOR PRODUCT. ON (B)(6) 2025, THE PATIENT WAS REVISED TO MEDACTA IMPLANTS. ON, (B)(6) 2025, THE PATIENT CAME IN DUE TO PAIN AND FEELING UNSTABLE AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY AND PATELLA, IMPLANTING THICKER IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. UPON REMOVING THE POLY, THE SURGEON REMOVED MULTIPLE OSTEOPHYTES DUE TO PATIENT PATHOLOGY AND CEMENT CHUNKS (COMPETITOR CEMENT).

  Patient problems: Joint Laxity

  MAUDE report 23579961 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22157482 ↗