GMK Revision Total Knee System 02.07.2404LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030821424), received between Feb 25, 2020 and Dec 18, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AFTER 4 YEARS AND 10 MONTHS DUE TO A LOOSE FEMORAL COMPONENT. THE SURGEON REVISED THE FEMUR AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23836924 ↗
• InjuryOct 10, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 2 YEARS FROM MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND ADDED CONES FOR MORE FIXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 17904911 ↗
• InjuryJul 19, 2021Unstable

  THE PATIENT HAD A PRIMARY RIGHT KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY WAS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2021, 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.

  Patient problems: Unspecified Infection

  MAUDE report 12188683 ↗
• InjuryOct 6, 2020Fracture

  THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURE AT FEMORAL LEVEL THAT WAS CAUSED FROM THE PATIENT STEPPING AND TWISTING HER LEG. THE SURGEON CABLED AND PLATED THE FRACTURE AND DID NOT REVISE ANY COMPONENTS 1 MONTH AFTER PREVIOUS SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD A PRIMARY IMPLANTED WITH COMPETITOR PRODUCTS, ON (B)(6) 2020 THE COMPETITOR PRODUCTS WERE REVISED WITH MEDACTA PRODUCTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 10634600 ↗
• InjuryFeb 25, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AFTER 3 YEARS AND 4 MONTHS FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGERY REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUSLY THIS PATIENT HAD TWO REVISIONS DUE TO AN INFECTION. DURING THE FIRST THE INLAY WAS CHANGED, DURING THE SECOND ALL THE HARDWARE WAS CHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 9749832 ↗