GMK Revision Total Knee System 02.07.0682LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030819346), received between Oct 31, 2017 and Nov 12, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• InjuryNov 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2022, THE PATIENT HAD PRIMARY LEFT KNEE SURGERY. ON (B)(6) 2022, THE PATIENT HAD KNEE PAIN. THE SURGEON DECIDED TO REVISE THE PATIENT AND DISCOVERED THAT TIBIA, FEMUR, AND PATELLA WERE LOOSE AND DID NOT BOND WITH THE CEMENT. THE CAUSE OF THIS IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS. MDR 3005180920-2022-00412. ON (B)(6) 2025, THE PATIENT HAD KNEE PAIN DUE TO LOOSENING OF THE CEMENTED FEMORAL AND TIBIAL COMPONENTS. THE SURGEON REVISED ALL COMPONENTS TO GMK-REVISION AND ADDED CONES FROM A COMPETITOR. THE RESURFACED PATELLA FROM THE FIRST REVISION WAS RETAINED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23532098 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING STIFFNESS IN THE KNEE DUE TO THE PRESENCE OF SCAR TISSUE. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Scar Tissue

  MAUDE report 15348723 ↗
• InjuryMay 23, 2018Insufficient Device Problem Information

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 YEAR AND 3 MONTHS AFTER THE PRIMARY. THE PATHOGEN IS NOT AVAILABLE. THE SURGEON REVISED ALL HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7536832 ↗
• InjuryMar 14, 2018Unstable

  ON (B)(6) 2018 MEDACTA HAS BEEN INFORMED BY THE SALES AGENT THAT PATIENT CAME IN COMPLAINING OF INSTABILITY. SURGEON PLANS TO REMOVE IMPLANTS AND INPUT ANOTHER COMPANY'S PRODUCT. ON (B)(6) 2018 WE WERE INFORMED THAT PATIENT REVISION SURGERY HAS NOT BEEN RESCHEDULED YET, MAYBE IT WILL BE DONE IN (B)(6) 2018.

  Patient problems: Joint Disorder

  MAUDE report 7338217 ↗
• InjuryOct 31, 2017Positioning Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE TIBIAL TRAY WAS MALROTATED. THE SURGEON REVISED THE TIBIAL TRAY, INSERT, TIBIAL AUGMENTS, AN EXTENSION STEM, AND OFFSET CONNECTOR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 6990603 ↗