GMK Revision Total Knee System 02.07.2403LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030821400), received between Sep 7, 2018 and Apr 26, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS IN THE KNEE AND THE CAUSE OF THE PAIN AND STIFFNESS IS UNKNOWN. AT ALMOST 2 YEARS AND 10 MONTHS AFTER PRIMARY THE SURGEON REVISED THE EXTENSION STEM, FEMUR, AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 14202531 ↗
• InjuryOct 7, 2020Inadequacy of Device Shape and/or Size

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 4 MONTHS DUE TO STIFFNESS IN THE KNEE PROBABLY DUE TO AN OVERSIZED FEMUR. THE SURGEON REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 10640903 ↗
• InjuryAug 5, 2020Fracture

  DURING THE PRIMARY KNEE SURGERY, WHILE THE SURGEON WAS TRIALING THE SC TRIAL INSERT WITH THE FINAL FEMORAL AND TIBIAL IMPLANTS, THE TRIAL INSERT WOULD NOT LOCK INTO THE FINAL TIBIAL BASEPLATE. DURING THIS TRIAL RANGE OF MOTION A FRACTURE OF THE MEDIAL DISTAL FEMORAL CONDYLE WAS NOTICED. THE SURGEON CABLED THE FRACTURE TO STABILIZE THE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON WAS ABLE TO INSERT THE FINAL IMPLANT POLY INSERT INTO THE BASEPLATE. THE FRACTURE MAY HAVE DEVELOPED WHEN IMPACTING THE FEMORAL IMPLANT COMPONENT. FURTHER, THE BONE WAS OF VERY POOR QUALITY AND WAS DEFICIENT IN MUCH OF THE DISTAL FEMUR. WE ALSO USED A FEMORAL CONE AUGMENT TO TRY TO REINFORCE THE DISTAL FEMUR WHICH REQUIRED FURTHER REMOVAL OF SOME REMAINING CANCELLOUS DISTAL BONE. THE MEDIAL DISTAL FEMORAL CONDYLE DIDN'T PARTIALLY DISPLACE HOWEVER UNTIL WE WERE DOING A TRIAL RANGE OF MOTION WITH THE TRIAL INSERT PAIRED WITH THE FINAL IMPLANT FEMORAL AND TIBIAL COMPONENTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 10366570 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY 6 MONTHS AFTER PRIMARY SURGERY, DUE TO INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8711713 ↗
• MalfunctionSep 7, 2018Packaging Problem; Packaging Problem

  UPON OPENING THE INNER PACKAGING IT WAS NOTICED THAT IT WAS COMPROMISED AND WAS NOT DEEMED TO BE STERILE. AN ALTERNATIVE IMPLANT THAT WAS AVAILABLE HAS BEEN USED.

  Patient problems: No Code Available

  MAUDE report 7854962 ↗