GMK Revision Total Knee System 02.07.0312SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030817175), received between Jul 13, 2017 and Oct 16, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY LEFT KNEE SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. (MDR: (B)(4). ON (B)(6) 2025. PERMANENT IMPLANTS WERE PLACED (GMK-REVISION). ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23310523 ↗
• InjuryJun 20, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 5 MONTHS 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: Unspecified Infection

  MAUDE report 19573512 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 YEARS AND 2 MONTHS AFTER THE PREVIOUS REVISION SURGERY (WHEN MEDACTA GMK REVISION COMPONENTS HAVE BEEN IMPLANTED), THE PATIENT CAME IN REPORTING STIFFNESS IN THE KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HAD COMPETITOR COMPONENTS PRIOR TO MEDACTA REVISION COMPONENTS.

  Patient problems: Loss of Range of Motion

  MAUDE report 19085909 ↗
• InjuryJul 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS 9 MONTHS AFTER 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: Unspecified Infection

  MAUDE report 17412885 ↗
• InjuryJun 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 YEARS 8 MONTHS AFTER THE PRIMARY, 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. THE PRIMARY WAS FROM A COMPETITOR AND THE SURGEON REVISED THE COMPETITOR TO MEDACTA REVISION COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 17190244 ↗
• InjuryDec 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Unspecified Infection

  MAUDE report 16068470 ↗
• InjuryApr 1, 2022Material Too Rigid or Stiff

  THE PATIENT WAS IMPLANTED WITH COMPETITOR KNEE COMPONENTS. ON (B)(6) 2021, THE PATIENT HAD THE COMPETITOR COMPONENTS REMOVED DUE TO AN INFECTION AND THE SURGEON IMPLANTED AN INSERT AND FEMORAL COMPONENT AS A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022 THE PATIENT HAD THE SPACER REMOVED AND THE SURGEON REVISED THE PATIENT WITH ALL NEW MEDACTA HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022 THE PATIENT CAME IN REPORTING TIGHTNESS IN THE KNEE AND THE CAUSE OF THE TIGHTNESS IS UNKNOWN. THE SURGEON REVISED THE LINER (20 MM TO 10 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 13975654 ↗
• InjurySep 27, 2021Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 12532040 ↗
• InjuryJul 7, 2021Appropriate Device Problem Term/Code Not Available

  1 MONTH 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 AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12126586 ↗
• InjuryFeb 18, 2020Appropriate Device Problem Term/Code Not Available

  TWO YEARS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING PAIN DUE TO LACK OF RANGE OF MOTION. THE SURGEON PERFORMED A MENISCECTOMY AND REVISED THE MEDACTA INSERT SEMICONSTRAINED 12MM S3 WITH A MEDACTA INSERT SEMICONSTRAINED 10MM S3 ALMOST 2 YEARS AFTER PREVIOUS SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9719558 ↗
• InjuryOct 2, 2019Appropriate Device Problem Term/Code Not Available

  ON THE 3 SEPTEMBER 2019 WE WERE INFORMED OF A REVISION SURGERY PERFORMED ON THE (B)(6) 2019, 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO STIFFNESS OF THE KNEE. THE SURGEON PERFORMED A LINER SWAP (SIZE 12 MM TO 10 MM) SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9144400 ↗
• InjuryJul 13, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION WAS SUPERFICIAL. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6710491 ↗