GMK Revision Total Knee System 02.07.0317SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630030817410), received between Dec 28, 2020 and Sep 3, 2025 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Adverse 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) 2024. ON (B)(6) 2024, THE PATIENT HAD ANTERIOR PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS WITH REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT HAD STIFFNESS AND LACK OF RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE POLY TO GIVE THE PATIENT MORE RANGE OF MOTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 22949880 ↗
• InjuryJun 12, 2025Migration; Migration

  ABOUT 3 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SUPPORT PEG IS UNSCREWED. THE PATIENT COMPLAINS ABOUT INSTABILITY AND PAIN. REVISION SURGERY PERFORMED 3 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY. ONLY THE INLAY AND PEG REVISED (WITH 20MM INLAY). TORQUE LIMITER 6NM USED AT THE PRIMARY SURGERY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 22194900 ↗
• InjuryJan 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2023. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE PATELLA IMPLANT, TIBIAL TRAY, TIBIAL INSERT AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 21053559 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY COMPETITOR KNEE SURGERY AND CAME IN DUE TO SIGNS OF AN INFECTION. ON (B)(6) 2021, THE SURGEON REVISED THE COMPETITOR COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT CAME IN AND HAD THE ANTIBIOTIC SPACER REMOVED AND HAD GMK-REVISION COMPONENTS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19465901 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD STIFFNESS IN THE KNEE AND THE CAUSE IS UNKNOWN. AT ABOUT 2 YEARS AND 11 MONTHS POST PRIMARY THE SURGEON REVISED THE SEMICONSTRAINED LINER AND IMPLANTED A POSTERO-STABILIZED LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 18901162 ↗
• InjuryOct 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 5 MONTHS FROM MEDACTA PRIMARY 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

  MAUDE report 17995656 ↗
• InjuryJul 15, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 2 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15027964 ↗
• InjuryMay 12, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A COMPETITOR PRIMARY SURGERY AND THEN WAS REVISED WITH MEDACTA COMPONENTS ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN PATELLA TENDON. THE SURGEON PREFORMED A PATELLA TENDON REPAIR AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 14367137 ↗
• InjuryDec 28, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH COMPETITOR IMPLANTS. ON (B)(6) 2020, THE PATIENT CAME IN AND HAD THE COMPETITOR PRODUCTS REVISED FOR REASONS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, ONE MONTH AFTER PREVIOUS SURGERY, 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 11077211 ↗