GMK Revision Total Knee System 02.07.0412SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630030817755), received between Nov 16, 2017 and Aug 11, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Migration; Migration

  PRIMARY SURGERY PERFORMED ON (B)(6) 2025. ABOUT 1 MONTH AFTER THE SURGERY, THE PEG OF THE INSERT IS FOUND TO BE UNSCREWED, AND THE INSERT IS DISLOCATED FROM THE TIBIAL TRAY. A POSTOPERATIVE X-RAY TAKEN ON (B)(6) (THREE DAYS AFTER THE SURGERY) REVEALED THAT THE INLAY AND SCREW WERE NOT CORRECTLY POSITIONED. DUE TO RECURRENT CLICKING NOISES IN THE KNEE, THE PATIENT LATER CONSULTED HIS GENERAL PRACTITIONER, WHO ARRANGED FOR A FURTHER X-RAY EXAMINATION. ALTHOUGH THE PATIENT REPORTED NO PAIN AND WAS ABLE TO WALK WELL, HE WAS UNABLE TO ACHIEVE FULL EXTENSION. THEN, THE SURGEON ARRANGED FOR ANOTHER RADIOGRAPHIC EXAMINATION AT THE REVISION HOSPITAL ON (B)(6) 2025 AND THE UNSCREWED PEG AND DISSOCIATED INLAY WERE DETECTED. REVISION SURGERY PERFORMED ON (B)(6) 2025. INSERT AND PEG REVISED. THE ISSUE APPEARS TO HAVE BEEN PRESSURE FROM THE FEMORAL COMPONENT ON THE INLAY WHEN THE TIBIA WAS NOT HELD IN AN OPTIMAL POSITION. DURING THE INITIAL ATTEMPT, THE INLAY ENGAGED BUT DID NOT SEAT PROPERLY IN THE POSTERIOR PART OF THE TIBIA. AS A RESULT, THE SCREW COULD NOT BE INSERTED EASILY AND JAMMED WHEN USING THE TORQUE SCREWDRIVER.

  Patient problems: Implant Pain

  MAUDE report 22769928 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 1 MONTH AND A HALF FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A QUAD TENDON RUPTURE AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A QUAD TENDON REPAIR AND UPSIZED THE POLY (FROM 12 TO 14 MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Damage to Ligament(s); Joint Laxity

  MAUDE report 22749125 ↗
• InjuryJul 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH 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 22493703 ↗
• InjuryJul 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AND A HALF 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 19749125 ↗
• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED 2 YEARS 3 MONTHS AFTER THE PREVIOUS SURGERY DUE TO SIGNS OF INFECTION. TIBIAL INSERT SUCCESSFULLY REVISED. THIS IS THE 4TH OPERATION ON A PATIENT WITH TKA AND THE FIRST SURGERY CAUSED BY INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12067155 ↗
• InjuryMar 31, 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 AN I&D AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUSLY THE PATIENT HAD IMPLANTED COMPETITOR IMPLANTS, AND ON (B)(6) 2021 MEDACTA IMPLANTS WERE IMPLANTED DUE TO UNKNOWN REASON.

  Patient problems: Unspecified Infection

  MAUDE report 11593955 ↗
• InjuryJan 13, 2020Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 9580029 ↗
• InjuryJul 20, 2018Material Too Rigid or Stiff

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE KNEE WAS A LITTLE STIFF. ON (B)(6) 2018 THE SURGEON PERFORMED A POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7706392 ↗
• InjuryNov 16, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON WAS UNABLE TO DETERMINE THE CAUSE OF PAIN. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7037279 ↗