GMK Primary Total Knee System 02.07.2202RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030820816), received between Dec 17, 2019 and Dec 17, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT COMPLAINED OF PAIN IN THE KNEE, IN THE ANTERIOR REGION. WHEN THE SURGEON OPENED THE KNEE, HE NOTICED LOOSENING OF THE FEMORAL COMPONENT AND LOOSENING OF THE TIBIAL IMPLANT, SO EVERYTHING WAS REMOVED. IT WAS NOTICED A LARGE DEFECT ON THE INTERNAL PART OF THE FEMORAL CONDYLE. THE SURGEON DID NOT NOTICE ANYTHING ABOUT THE RXS AT HIS DISPOSAL. UNFORTUNATELY, A REVISION SYSTEM WAS NOT AVAILABLE ONLY A GMK PRIMARY (IMPLANTS AND INSTRUMENTATION) WAS AVAILABLE. SO THE SURGEON PERFORMED THE REVISION WITH PRIMARY SYSTEM AND COMPENSATED THE DEFECTS WITH CEMENT 8 YEARS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 9479694 ↗

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