GMK Primary Total Knee System 02.07.2214LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030820984), received between Sep 7, 2017 and Jul 25, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CALLED MEDACTA US COMPLAINING OF PAIN. THE PATIENT WILL LIKELY UNDERGO ADDITIONAL SURGERY. THE DATE OF THE REVISION IS UNKNOWN. THE REVISING SURGEON IS UNKNOWN. NO ADDITIONAL INFORMATION WILL BE PROVIDED BY THE PATIENT.

  Patient problems: Pain

  MAUDE report 7718471 ↗
• InjurySep 7, 2017Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE FEMUR WAS LOOSE. THE SURGEON REVISED THE FEMUR, TIBIA AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6847608 ↗