GMK Revision Total Knee System 02.07.0210SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030816499), received between Dec 6, 2018 and Jul 15, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Medical device site infection

  MAUDE report 22505896 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 YEARS AND 10 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (10MM) WITH A THICKER ONE (12MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ISSUES WITH THE OTHER IMPLANTS DETECTED.

  Patient problems: Joint Laxity

  MAUDE report 20745686 ↗
• InjurySep 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 15 DAYS FROM THE PRIMARY MEDACTA 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 problems: Medical device site infection; Unspecified Infection

  MAUDE report 20244171 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED DUE TO QUAD TENDON RUPTURE AND THE CAUSE OF THE RUPTURE IS UNKNOWN. THE SURGEON REPAIRED THE QUAD TENDON AND REVISED THE LINER 11 MONTHS AFTER A FIRST REVISION SURGERY (WHICH WAS DUE TO KNEE STIFFNESS). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Tissue Breakdown

  MAUDE report 11300090 ↗
• InjuryMar 24, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD COMPETITOR ITEMS IMPLANTED DURING PRIMARY, WHICH WERE THEN REVISED WITH MEDATCA PRODUCTS. THEN THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP 15 DAYS AFTER PREVIOUS SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9870992 ↗
• InjuryDec 6, 2018Difficult or Delayed Positioning

  THE PATIENT CAME IN DUE TO AN UNSTABLE COMPETITOR'S KNEE CONSTRUCT. THE SURGEON REVISED ALL COMPETITOR HARDWARE WITH MEDACTA HARDWARE. THE SURGEON ATTEMPTED TO IMPLANT THE S2 10MM SEMI CONSTRAINED (LOT 140467) INSERT BUT IT WOULD NOT FIT INTO THE TIBIAL TRAY. THE SURGEON THEN SUBLUXED THE TIBIA FORWARD IN AN EFFORT TO INSERT A SECOND S2 10MM SEMI CONSTRAINED INSERT. WHEN THE SURGEON SUBLUXED THE TIBIA FORWARD, THE LCL TENDON TORE AWAY BONE FROM THE FEMUR. THE LCL TENDON WAS THEN SCREWED INTO PLACE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Excessive Tear Production

  MAUDE report 8137080 ↗