GMK Sphere Total Knee System 02.12.0310CRRRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630040707343), received between Aug 5, 2020 and Mar 10, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AT ABOUT 3 YEARS AND 2 MONTHS DUE TO PAIN AND INSTABILITY AS A RESULT OF A PCL TEAR. THERE WAS NO INDICATION OF TRAUMA OR A FALL. THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND REVISED THE 10MM INSERT TO A 14MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Damage to Ligament(s); Joint Laxity

  MAUDE report 24558215 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING LATERAL INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE LINER (10 TO 12 MM) FOR STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22000386 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (FROM 10 TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21033590 ↗
• InjuryAug 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND HAD A BONE SCAN PERFORMED, WHICH INDICATED POSSIBLE LOOSENING OF THE TIBIAL TRAY. AT ABOUT 2 YEARS AND 11 MONTHS POST PRIMARY THE SURGEON OPENED THE KNEE AND FOUND THAT THE TIBIAL TRAY WAS WELL FIXED. THE SURGEON PERFORMED A POLY SWAP (SAME REF BUT E-CROSS) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20026724 ↗
• InjuryJun 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 4 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT (FROM 10 TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19605536 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (10MM TO 12 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16900771 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING KNEE INSTABILITY. AFTER AN EXAMINATION, THE SURGEON SPOKE ABOUT THE BENEFITS OF THE MORE CONSTRAINED MEDIAL BALL IN SOCKET (E CROSS FLEX) LINER. THE PATIENT AGREED TO DO A LINER EXCHANGE (FIXED CR 10 MM TO E-CROSS FLEX 13 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15604928 ↗
• InjuryAug 5, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT CAME IN REPORTING DISCOMFORT DUE TO DEVELOPING AN ALLERGIC REACTION. THE SURGEON REMOVED ALL COMPONENTS AND REPLACE THEM WITH OXINIUM COMPETITOR IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY 11 MONTHS AFTER PRIMARY.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction

  MAUDE report 10366325 ↗