GMK Sphere Total Knee System 02.12.0510CRLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040707619), received between Jul 28, 2021 and Jun 13, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Unstable” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 2 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14673490 ↗
• InjuryMay 23, 2022Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT WITH AN 11MM ONE ALMOST 1 YEAR AND 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 14468722 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING DISCOMFORT AND INSTABILITY AFTER DOING LATERAL MOTIONS AT WORK. X-RAY'S CONFIRMED THE POLY WAS DISENGAGED FROM THE TIBIA TRAY. ABOUT 3 MONTHS AND A HALF, THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE INSERT WAS PROPERLY ENGAGED IN THE PRIMARY SURGERY AND THE CLIPPING NOISE WAS HEARD.

  Patient problems: Discomfort

  MAUDE report 12868143 ↗
• InjuryAug 31, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A PAINFUL TIBIA AND THE CAUSE OF THE PAINFUL TIBIA IS UNKNOWN. 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL THE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12391865 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem

  3 MONTHS AFTER THE PRIMARY 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 12237427 ↗