GMK Revision Total Knee System 02.07.0510SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030818233), received between Mar 23, 2021 and Feb 6, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT PREVIOUSLY HAD COMPETITOR COMPONENTS, WHICH WERE THEN REVISED TO MEDACTA.

  Patient problems: Unspecified Infection

  MAUDE report 21320665 ↗
• InjuryOct 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20464801 ↗
• InjurySep 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 YEARS AND 6 MONTHS AFTER THE PREVIOUS REVISION SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HAD COMPETITOR IMPLANTS BEFORE GMK-REVISION WAS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20298887 ↗
• InjuryJul 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19642079 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRIMARY WAS A REVISION OF COMPETITOR COMPONENTS.

  Patient problems: Medical device site infection

  MAUDE report 18324596 ↗
• InjuryApr 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT ORIGINALLY HAD COMPETITOR COMPONENTS AND THEN WAS IMPLANTED WITH MEDACTA REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 16813410 ↗
• InjuryMay 3, 2022Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 14267182 ↗
• InjurySep 27, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 YEAR AND 10 MONTHS AFTER PREVIOUS SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT UNDERWENT A PREVIOUS REVISION, COMPETITOR'S DEVICES WERE EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 12532143 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem

  1 MONTH AFTER THE PREVIOUS REVISION SURGERY (PERFORMED DUE TO INFECTION, THE LINER WAS REVISED), THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11581251 ↗
• InjuryMar 23, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11551136 ↗