GMK Revision Total Knee System 02.07.0314SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07630030817298), received between Jan 16, 2019 and Mar 31, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY WITH GMK-SPHERE COMPONENTS. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING ANTERIOR PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS WITH REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY MDR 2024-00690. ON (B)(6) 2026, THE PATIENT CAME IN REPORTING 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 MDR2025-00810. ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING LIMITED RANGE OF MOTION WITH A STIFF KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE 11MM INSERT TO A 10MM INSERT AND REVISED THE 14MM PEG TO A 10MM PEG. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED - 02.07.0310SCF INSERT SEMICONSTRAINED 10MM S3 2523107 02.07. SCP10 TINBN COATED SC PEG - 10MM 2112334.

  Patient problems: Loss of Range of Motion

  MAUDE report 24738826 ↗
• InjuryMar 5, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD REVISION RIGHT KNEE SURGERY OF COMPETITOR IMPLANTS TO MEDACTA IMPLANTS ON (B)(6) 2024. ON (B)(6) 2025, 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. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN TO HAVE ANTIBIOTIC SPACERS THAT WERE PUT IN ON (B)(6) 2026 TO TREAT INFECTION WITH THE PATHOGEN UNKNOWN. THE SURGEON REVISED THE TRAY AND FEMORAL COMPONENT AND UPSIZED THE LINER FROM 14MM TO 17MM TO MITIGATE ANY BONE LOSS FROM MULTIPLE SURGERIES THAT MAY HAVE CONTRIBUTED TO A LEG LENGTH ISSUE AND RESURFACED THE NATURAL PATELLA BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24518515 ↗
• InjurySep 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 YEAR AND 7 MONTHS FROM MEDACTA 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 23071044 ↗
• InjuryFeb 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAS PRIMARY COMPETITOR'S COMPONENTS BEFORE BEING REVISED TO MEDACTA.

  Patient problems: Medical device site infection

  MAUDE report 21321576 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 18806017 ↗
• InjuryJan 17, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 2 YEARS AND 11 MONTHS AFTER THE PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HAD REVISION COMPONENTS IMPLANTED AFTER HAVING COMPETITOR IMPLANTS ON THE (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 18524337 ↗
• InjurySep 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH 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 17709127 ↗
• InjuryMay 5, 2023Device 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 2 YEARS FROM PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16874618 ↗
• InjuryAug 17, 2022Material Too Rigid or Stiff; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2019. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO LOOSE IMPLANTS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT SEMICONSTRAINED 14MM S3 WITH AN INSERT SEMICONSTRAINED 10MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 15240571 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem

  10 MONTHS AFTER THE REVISION SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION (PATHOGEN UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD A PRIMARY WITH COMPETITOR COMPONENTS, MEDACTA IMPLANT WAS IMPLANTED IN THE FIRST REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 12165048 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem

  3 MONTHS AFTER THE PREVIOUS REVISION SURGERY (DUE TO INSTABILITY) 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 11364282 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ABOUT 3 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT WAS HAVING PAIN DUE TO AN IMPINGEMENT OF THE EXTENSION STEM AND THE TIBIAL BONE. A CORTICAL THICKENING HAS BEEN OBSERVED. NO METALLOSIS DETECTED. THE SURGEON REVISED THE TIBIAL TRAY, EXTENSION STEM AND LINER.

  Patient problems: Joint Disorder

  MAUDE report 10349985 ↗
• InjuryFeb 6, 2019Device Slipped

  ABOUT 6 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR LAXITY. LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8310184 ↗
• InjuryJan 16, 2019Failure to Form Staple

  THE PATIENT CAME IN DUE TO LAXITY, 2 YEARS AND 7 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED THE 14MM POLY WITH A 20MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8252593 ↗