GMK Revision Total Knee System 02.07.0517SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030818578), received between Aug 5, 2020 and Aug 3, 2026 — classified as 8 injuries.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  Revision surgery due to knee instability after about 3 years and 7 months from primary. The surgeon revised the femur with a femur of the same size with distal and posterior augments and upsized the poly for more stability.

  Patient problems: Joint Laxity

  MAUDE report 50114122 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2023. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. PRESENTLY, ON (B)(6) 2025, THE SURGEON REVISED THE 17MM POLY WITH A 14MM LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21739733 ↗
• InjuryMar 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 3 WEEKS 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: Medical device site infection

  MAUDE report 18815070 ↗
• InjuryFeb 27, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A COMPETITOR PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE LINER. 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 SUCCESSFULLY THE LINER.

  Patient problems: Medical device site infection

  MAUDE report 18788786 ↗
• InjuryApr 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. AT 2 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16722679 ↗
• InjuryAug 30, 2021Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2020, THE PATIENT HAD THE COMPETITOR COMPONENTS REVISED TO MEDACTA COMPONENTS FOR REASONS UNKNOWN. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING DISCOMFORT DUE TO A FLEXION CONTRACTURE AND THE CAUSE OF THE FLEXION CONTRACTURE IS UNKNOWN. THE SURGEON REVISED THE 17MM INSERT WITH A 14MM ONE, ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 12382908 ↗
• InjurySep 30, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 1 MONTH AFTER PRIMARY SURGERY, 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 10604871 ↗
• InjuryAug 5, 2020Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 10366327 ↗