GMK Sphere Total Knee System 02.12.0311CRLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040707350), received between Jul 23, 2021 and Jun 25, 2024 — classified as 3 injuries.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS AND 1 MONTH FRON THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY (FROM 11 TO 14 MM) AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19603232 ↗
• InjuryNov 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PRIMARY SURGERY PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15797475 ↗
• InjuryJul 23, 2021Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. ABOUT 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE GMK SPHERE CR TIBIAL INSERT S3L 11MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S3L - 17MM TO GIVE THE PATIENT MORE STABILITY.

  Patient problems: Joint Laxity

  MAUDE report 12216119 ↗