GMK Primary Total Knee System 02.07.2216LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030821028), received between Oct 6, 2017 and Jun 28, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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.

• InjuryJun 28, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS PERFORMED DUE TO CEMENTED TIBIAL AND FEMUR LOOSENING, 5 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 14840042 ↗
• InjuryOct 17, 2018Loss of or Failure to Bond; Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY THREE YEARS AFTER PRIMARY SURGERY. THE SURGEON DETERMINED THAT THE CEMENT DID NOT ADHERE TO THE IMPLANTS, HE REMOVED THE FEMUR, TIBIA AND INSERT. THE PATELLA REMAINED, AS IT WAS WELL FIXED. PALACOS CEMENT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7973277 ↗
• InjuryOct 6, 2017Failure To Adhere Or Bond; Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. UPON REMOVAL OF THE COMPONENTS THE SURGEON DETERMINED THE CEMENT DID NOT ADHERE TO THE TIBIAL BASEPLATE. THE SURGEON REVISED THE FEMUR, INSERT AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 6921702 ↗