GMK Primary Total Knee System 02.07.0317FUCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030817359), received between Aug 22, 2018 and Aug 9, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

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.

• InjuryAug 9, 2019Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY WHICH WAS CAUSED BY LAXITY. THE SURGEON REVISED THE 17MM POLY WITH A 20MM POLY 3 YEARS AND 1 WEEK AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8878376 ↗
• InjuryAug 22, 2018Unstable

  THE PATIENT CAME IN COMPLAINING OF PAIN AND INSTABILITY 3 YEARS AND 9 MONTHS. THE SURGEON UPSIZED THE POLY FROM 17MM TO 23MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7804987 ↗

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