GMK Primary Total Knee System 02.07.2002RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030820182), received between Aug 27, 2020 and Nov 22, 2021 — 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.

• InjuryNov 22, 2021Appropriate Device Problem Term/Code Not Available

  AT 9 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12851834 ↗
• InjuryAug 27, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN AFTER 9 YEARS AND 2 MONTHS FORM THE PRIMARY SURGERY FOR A POST-OP APPOINTMENT. X-RAYS INDICATED A LOOSE FEMORAL COMPONENT AND TIBIAL TRAY. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10458656 ↗

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