GMK Revision Total Knee System 02.07.0310SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07630030817076), received between Jan 12, 2018 and Jul 22, 2025 — classified as 12 injuries, 1 malfunction.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 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: Medical device site infection

  MAUDE report 22564635 ↗
• InjuryJun 13, 2025Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  REVISION SURGERY PERFORMED ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO INLAY DISLOCATION. AS VISIBLE FROM THE XRAYS, THE SUPPORT PEG IS UNSCREWED. ONLY THE INLAY AND PEG HAVE BEEN REVISED. TORQUE LIMITER 6NM USED AT THE PRIMARY SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 22201099 ↗
• InjuryMay 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED NEW COMPONENTS THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19307424 ↗
• InjuryApr 10, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AFTER MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HAD COMPETITOR COMPONENTS PRIOR TO MEDACTA REVISION SYSTEM IMPLANTATION.

  Patient problems: Unspecified Infection

  MAUDE report 19077327 ↗
• InjuryApr 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON THE (B)(6)2022. ON THE (B)(6)2023, THE PATIENT WAS REVISED BECAUSE OF CAPSULE TEAR, DISLOCATED PATELLA AND SUBSIDED FEMORAL STEM. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL AND TIBIAL COMPONENTS. PRESENTLY, ON THE (B)(6) 2023, 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 16680116 ↗
• InjuryFeb 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY SURGERY WITH COMPETITOR COMPONENTS AND WAS REVISED TO MEDACTA REVISION COMPONENTS ON THE (B)(6) 2019. PRESENTLY ON THE (B)(6) 2023, 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 16322189 ↗
• InjuryMar 1, 2022Appropriate Device Problem Term/Code Not Available

  AT 4 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13631037 ↗
• InjuryJan 24, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2020. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING A LACK OF RANGE OF MOTION. THE SURGEON REVISED THE FEMORAL COMPONENT AND TIBIAL INSERT ON (B)(6) 2021. PRESENTLY, ABOUT 10 MONTHS AFTER THE PREVIOUS REVISION SURGERY, THE PATIENT CAME IN REPORTING MID-RANGE INSTABILITY AND AN INABILITY TO ACHIEVE FULL FLEXION. THE SURGEON REVISED THE 10MM POLY WITH A 14MM POLY AND REVISED THE PATELLA IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13333119 ↗
• InjuryOct 25, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 4 DAYS AFTER PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUSLY THE PATIENT WAS REVISED FROM COMPETITOR TO MEDACTA IMPLANTS (THUS, FOR THE PATIENT THIS IS THE 2ND REVISION SURGERY BUT THE 1ST CONSIDERING MEDACTA IMPLANTS).

  Patient problems: Unspecified Infection

  MAUDE report 12687964 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem

  ABOUT 2 YEARS AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR A INFECTION. LINER SWAP ONLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7685640 ↗
• InjuryApr 27, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO SIGNS OF INFECTION 1 MONTH AFTER PRIMARY SURGERY. THE PATHOGEN IS UNAVAILABLE. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 7468214 ↗
• InjuryJan 12, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT TESTED POSITIVE FOR STREPTOCOCCI. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7185377 ↗
• MalfunctionJan 12, 2018Device Issue; Device Issue

  DURING SURGERY WHEN THE SURGEON WENT TO SEAT THE INSERT, IT WOULDN'T SEAT. THE SURGEON USED A SECONDARY MEDACTA'S INSERT WHICH WAS IMPLANTED WITH NO ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7185376 ↗