GMK Sphere Total Knee System 02.12.0510CRRRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630040707626), received between Nov 24, 2021 and Feb 6, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 2 YEARS AND 9 MONTHS DUE TO ANTERIOR KNEE PAIN AND KNEE INSTABILITY. THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND UPSIZED THE INSERT TO ADDRESS THE PATIENT`S INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24276576 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (10MM) WITH A THICKER ONE (13MM) AND THE SURGERY WAS COMPLETELY SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20578583 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE 10MM INSERT WITH A 13MM INSERT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18450040 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO DUE TO KNEE LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON AT ABOUT 3 YEARS AND 4 MONTHS POST PRIMARY, REVISED THE INSERT TO A THICKER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18245835 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AND 1 WEEK AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14588475 ↗
• InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 5 MONTHS AND A HALF FROM THE PRIMARY SURGERY THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13469422 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem

  AT 1 MONTH 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 12867528 ↗