GMK Revision Total Knee System 02.07.0684LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030819384), received between Sep 7, 2021 and Mar 22, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AND 9 MONTHS AFTER THE PREVIOUS REVISION SURGERIES, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE TIBIA AND INSERT. THIS IS THE 4TH REVISION SURGERY FOR THIS PATIENT. THE FIRST ONE WAS PERFORMED DUE TO LAXITY CAUSED BY A FALL AND THE INSERT WAS REVISED. THE SECOND REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY (REVISED THE INSERT AND TIBIAL TRAY). THE THIRD REVISION SURGERY WAS PERFORMED DUE TO A LOOSE TIBIAL TRAY CAUSED BY A TRAUMA (REVISION OF INSERT AND TIBIAL TRAY).

  Patient problems: Implant Pain

  MAUDE report 16589561 ↗
• InjuryDec 7, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY 7 YEARS AND 2 MONTHS AFTER MEDACTA KNEE IMPLANTATION FOR FEMORAL AND TIBIAL COMPONENTS LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 12947864 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH COMPETITOR PRODUCTS. ON (B)(6) 2020, THE PATIENT HAD THE COMPETITOR PRODUCTS REVISED TO MEDACTA PRODUCTS FOR REASONS UNKNOWN. 9 MONTHS AFTER MEACTA PRODUCT IMPLANTATION, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12433081 ↗