GMK Revision Total Knee System 02.07.0682RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030819353), received between Aug 21, 2019 and Apr 23, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2022,THE PATIENT CAME IN REPORTING PAIN DUE TO A TIBIAL PLATEAU FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR, TIBIA, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING TIBIAL PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 19163666 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS AND 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED MEDACTA TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 15995230 ↗
• InjuryApr 15, 2021Device Dislodged or Dislocated

  THE PATIENT HAD PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH COMPETITOR IMPLANTS. ON (B)(6) 2021, THE PATIENT HAD THE COMPETITOR IMPLANTS REVISED TO MEDACTA IMPLANTS AND THE CAUSE OF THE REVISION IS UNKNOWN. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A FAILED TIBIAL COMPONENT, WHICH SUBSIDED ON ONE SIDE. THE CAUSE OF THE FAILED TIBIAL COMPONENT IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT AND ADDED A FLUTED EXTENSION STEM AND TIBIAL AUGMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11670271 ↗
• InjuryAug 21, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. THE PATIENT SUBSEQUENTLY HAD A REVISION SURGERY ON (B)(6) 2019. THE PATIENT CAME IN COMPLAINING OF INSTABILITY AND THE SURGEON PERFORMED A POLY-SWAP. MDR 3005180920-2019-00047 WAS DONE. ON (B)(6) 2019, THE PATIENT CAME IN COMPLAINING OF INSTABILITY (1 YEAR AND 4 MONTHS AFTER PRIMARY SURGERY) AND MEDACTA INTERNATIONAL WAS INFORMED THE SAME DAY. THE SURGEON ON THE (B)(6) 2019 REVISED THE PATIENT AND PERFORMED A HINGED KNEE ARTHROPLASTY. ALL HARDWARE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8914342 ↗