GMK Primary Total Knee System 02.07.2214RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030820991), received between Oct 20, 2017 and Oct 27, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 3 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT LUXATED HER KNEE. DURING THE REVISION, IT WAS NOT POSSIBLE TO RESTORE THE CORRECT STABILITY BY USING INLAYS WITH DIFFERENT THICKNESS, SO THE WHOLE PROSTHESIS WAS REMOVED AND A HINGE SYSTEM WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 15679061 ↗
• InjuryAug 20, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS 4 MONTHS AFTER PRIMARY AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8909365 ↗
• InjuryOct 20, 2017Failure To Adhere Or Bond

  THE PATIENT CAME IN COMPLAINING OF STIFFNESS. THE SURGEON DETERMINED THE CEMENT (NON-MEDACTA PRODUCT) DID NOT ADHERE TO THE IMPLANTS. THE SURGEON REVISED THE FEMUR, INSERT AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 6965216 ↗