GMK Revision Total Knee System 02.07.0220SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030816932), received between Oct 13, 2020 and Mar 16, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION 1 MONTH AFTER THE PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT, I&D AND REVISED THE 20MM S2 SEMICONSTRAINED INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24603550 ↗
• InjuryJan 15, 2026Device Appears to Trigger Rejection

  THE PATIENT UNDERWENT AN INITIAL KNEE REPLACEMENT OF UNKNOWN DETAILS, INCLUDING IMPLANT TYPE AND HOSPITAL. ON (B)(6) 2025, THE SPACER WAS REMOVED AND MEDACTA REVISION IMPLANTS WERE IMPLANTED (REASON UNKNOWN). DUE TO PERSISTENT INFECTION, A FIRST POLY INSERT EXCHANGE SURGERY WAS PERFORMED ON 2(B)(6) 2025 (02.07.0220SCF, LOT 2317384), FOLLOWED BY A SECOND EXCHANGE ON (B)(6) 2026 (LOT 2118827) FOR THE SAME REASON. A NEW INSERT OF THE SAME SIZE WAS IMPLANTED. NO IMPLANT DEFECTS, LOOSENING, OR SIZING ISSUES WERE IDENTIFIED. INFECTION WITH SUSPECTED BIOFILM ON THE LINER. THE PATIENT HAS SEVERE COMORBIDITIES, INCLUDING BMI 44.1, WITH POTENTIAL RISK OF AMPUTATION.

  Patient problems: Medical device site infection

  MAUDE report 24078376 ↗
• InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR IMPLANTS. ON (B)(6) 2023, THE PATIENT WAS REVISED TO A MEDACTA REVISION SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO AN INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23579964 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 6 MONTHS AFTER THE MEDACTA PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATING COMPETITOR'S PATELLA IMPLANT AND A VERY LOOSE MEDIAL COLLATERAL LIGAMENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT FROM GMK-REVISION TO GMK- HINGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19623608 ↗
• InjuryJul 7, 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. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMUR AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 17276837 ↗
• InjuryFeb 10, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE SURGEON DECIDED TO RESURFACE THE PATIENT'S PATELLA. THE REASON FOR THIS ADDITIONAL PROCEDURE IS UNKNOWN. THE AGENT WAS NOT NOTIFIED OF THIS PROCEDURE UNTIL PRESENT AND A COMPLAINT WAS NOT FILED. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. IN 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED A SPACER. THE AGENT WAS NOT AWARE OF THIS PROCEDURE AND MEDACTA IMPLANTS WERE NOT NEEDED ON THIS OCCASION DUE TO THE IMPLANTATION OF THE SPACER. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REMOVED THE SPACER AND IMPLANTED A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13505752 ↗
• InjuryOct 13, 2020Unstable

  THE PATIENT HAD A PRIMARY SURGERY AND WAS IMPLANTED WITH COMPETITOR PRODUCTS. ON (B)(6) 2020, THE PATIENT HAD THE COMPETITOR PRODUCTS REVISED TO MEDATCA PRODUCTS. THE REASON FOR THE REVISION WAS UNKNOWN. PRESENTLY, ON (B)(6) 2020, 7 MONTHS AFTER PREVIOUS SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED ALL GMK-REVISION COMPONENTS TO GMK-HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 10669527 ↗