GMK Total Knee System 02.12.0722RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040711531), received between May 27, 2022 and Aug 7, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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.

• MalfunctionAug 7, 2025Positioning Problem; Positioning Problem

  DURING TKA THE EFFICIENCY TRIAL FEMORAL COMPONENT WAS USED TO TIRAL THE FEMUR AND DRILL THE HOLES FOR THE FEMORAL IMPLANT PEGS. AFTERWARD, WHEN TRYING TO INSERT THE FINAL IMPLANT THE SURGEON NOTICED THAT THE PEGS OF THE IMPLANTS WERE NOT ALIGNED WITH THE HOLES. THE MISMATCH WAS IN THE ANTERIOR DIRECTION OF APPROXIMATIVELY 5MM. SURGEON REMOVED THE IMPLANT, REDRILLED THE HOLES AND REFINED THE BONE CUTS. THE PATIENT BONE HAD TO BE RECEMENTED AGAIN AND FINALLY IMPLANT WAS POSITIONED. A TOTAL OF 20 MINUTES OF DELAY OVER 45 MINUTES OF SURGERY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737764 ↗
• InjuryMay 27, 2022Unstable; Malposition of Device; Malposition of Device

  THE PATIENT CAME IN REPORTING PATELLA INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON PLANS TO REVISE THE PATELLA IN (B)(6) 2022 (PRIMARY WAS ON THE (B)(6) 2021). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. MORE DETAILS TO FOLLOW ONCE REVISION TAKES PLACE.

  Patient problems: Insufficient Information

  MAUDE report 14522259 ↗