GMK Primary Total Knee System 02.07.2204RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030820854), received between Jun 1, 2018 and Oct 11, 2018 — classified as 2 injuries.

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

• InjuryOct 11, 2018Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN 4 YEARS AFTER PRIMARY. THE SURGEON DETERMINED THAT THE FEMUR WAS LOOSE. THE SURGEON REVISED THE FEMUR, PATELLA AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7956125 ↗
• InjuryJun 1, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO PAIN, THE FEMUR MALROTATED, 6 YEARS AND 10 MONTHS AFTER PRIMARY. THE PS KNEE WAS REVISED WITH A SEMI-CONSTRAINED KNEE.

  Patient problems: Pain

  MAUDE report 7560682 ↗

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