GMK Revision Total Knee System 02.07.2405RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030821455), received between May 4, 2018 and Sep 7, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY WAS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S5R - 14 MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S5R - 17 MM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS 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 REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE SURGEON REMOVED THE FEMUR AND INSERT THAT WAS IMPLANTED TO ACT AS A SPACER AND IMPLANTED A NEW FEMUR AND INSERT WITH ANTIBIOTIC CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE SURGEON REMOVED THE FEMUR AND INSERT THAT WAS IMPLANTED TO ACT AS A SPACER AND IMPLANTED REVISION KNEE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17697145 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem

  ONE YEAR AFTER PRIMARY THE PATIENT HAD A KNEE INFECTION. THE SURGEON REMOVED ALL THE IMPLANTS AND INSERTED A SPACER. LATER, ON THE (B)(6) 2018 SWAPPED THE SPACER WITH DEFINITIVE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7486990 ↗