GMK Sphere Total Knee System 02.12.0410CRRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630040707480), received between Jun 23, 2023 and Jan 13, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AND 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (10MM) WITH A THICKER ONE (12MM) FOR MORE MEDIAL CONSTRAINT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21135868 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 10 TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20732084 ↗
• InjurySep 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 YEAR AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17697147 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. AFTER THE PRIMARY KNEE SURGERY, THE PATIENT SUSTAINED A DISTAL FEMUR FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON PLATED THE FRACTURE AND DID NOT REVISE ANY IMPLANTS. ON (B)(6) 2023, THE PATIENT CAME IN TO HAVE THE PLATE REMOVED AND TO ADDRESS INDICATIONS OF INSTABILITY. THE SURGEON REMOVED THE KNEE PLATE AND UPSIZED THE POLY (FROM 10MM AND 13MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17485845 ↗
• InjuryJul 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 9 MONTHS POST PRIMARY DUE TO INFECTION, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17413826 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR KNEE INSTABILITY AT ABOUT 2 YEARS AND 8 MONTHS POST-PRIMARY. LINER REVISED SUCCESSFULLY TO A THICKER ONE.

  Patient problems: Joint Laxity

  MAUDE report 17190247 ↗