GMK Revision Total Knee System 02.07.2404RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030821431), received between Nov 27, 2019 and Jul 8, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2025, THE PATIENT WAS REVISED TO MEDACTA GMK-REVISION IMPLANTS. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVE ALL REVISION IMPLANTS FROM THE (B)(6) 2025 SURGERY. THE SURGEON PLACE ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25747729 ↗
• InjuryDec 5, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH AFTER A PRECEDENT REVISION FOR INFECTION THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMUR, THE TIBIAL INSERT AND THE TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT COMES FROM A PRECEDENT REVISION SURGERY FOR INFECTION (CASE CODE (B)(4), EMDR (B)(4)).

  Patient problems: Medical device site infection

  MAUDE report 20852293 ↗
• InjurySep 9, 2022Adverse 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) 2021. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE OF THE LOOSE FEMUR IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15392106 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem

  2 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUSLY THIS PATIENT WAS IMPLANTED WITH COMPETITOR IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 12353526 ↗
• InjuryNov 27, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 5 YEARS AFTER MEDACTA IMPLANT INSERTION THE SURGEON REVISED THE PATIENT KNEE FOR INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9382049 ↗