GMK Primary Total Knee System 02.07.2206LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030820885), received between Apr 20, 2018 and Jul 16, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K090988); they may or may not involve this specific model.

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.

• InjuryJul 16, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 2 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION IN BOTH KNEES AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED BILATERAL WASHOUT AND REVISED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10282570 ↗
• InjurySep 25, 2018Insufficient Device Problem Information

  ON (B)(6) 2020: THE PATIENT HAD PERMANENT HARDWARE IMPLANTED AND AN ANTIBIOTIC SPACER REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 7905433 ↗
• InjuryApr 20, 2018Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS DONE DUE TO LOOSENING OF FEMORAL AND TIBIAL COMPONENTS 3 YEARS AND 4 MONTHS AFTER PRIMARY.

  Patient problems: Joint Disorder

  MAUDE report 7446083 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090988. One submission often covers many models, so check the product and lot details in each record.

• Z-0266-2018 · Oct 24, 2017 · Terminated
  The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0