GMK Primary Total Knee System 02.07.0041IPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030815799), received between Mar 14, 2018 and Mar 14, 2018 — classified as 1 injury.

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.

• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem

  PATIENT WAS COMPLAINING OF PAIN IN THE KNEE 10 MONTHS AFTER PRIMARY. INTRA-OPERATIVELY IT WAS DISCOVERED THE PATIENT HAD SEVERE ARTHROFIBROSIS AND THAT SCAR TISSUE HAD GROWN OVER THE 24MM INSET PATELLA, CAUSING PATELLO-FEMORAL PAIN. THE SURGEON REMOVED THE SCAR TISSUE, REMOVED THE INSET PATELLA (NOT DEFECTIVE) RECUT AND USED A RESURFACING PATELLA SIZE 1 TO MINIMISE PRESSURE IN THE JOINT SPACE. HE ALSO REPLACED THE TIBIAL POLYETHELENE WITH THE SAME SIZE THOUGH THERE WAS NO DEFECT TO THE ORIGINAL.

  Patient problems: Joint Disorder

  MAUDE report 7338233 ↗

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