GMK Revision Total Knee System 02.07.0320SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030817519), received between Nov 8, 2018 and May 25, 2023 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 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 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17001453 ↗
• InjuryMar 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A COMPETITOR KNEE PRIMARY SURGERY AND WAS REVISED TO A MEDACTA KNEE SYSTEM ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON SUCCESSFULLY PERFORMED A WASHOUT AND REVISED THE INSERT. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 16494451 ↗
• InjuryDec 22, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A COMPETITOR'S KNEE AND SUBSEQUENTLY WAS REVISED TO A MEDACTA KNEE ON (B)(6) 2022. AT ABOUT 6 MONTHS POST-SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16032689 ↗
• InjuryNov 24, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY FOR KNEE INFECTION ABOUT 4 YEARS AFTER DEVICE IMPLANTATION. LOW-GRADE INFECTION, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED KNEE DEBRIDEMENT AND LINER SWAP SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10895746 ↗
• MalfunctionNov 8, 2018Connection Problem

  THE TIBIAL INSERT (22MM) WOULD NOT SNAP INTO THE TIBIAL TRAY. THE SURGEON ENDED UP DROPPING TO A 17MM INSERT AND THAT WORKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8050711 ↗