GMK Primary Total Knee System 02.07.2203RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030820830), received between Apr 4, 2025 and Apr 4, 2025 — 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.

• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED DUE TO PAIN AND PATELLA BONE MALTRACKING. THE REVISION SURGEON REPORTED THAT THE CAUSE FOR THE REPORTED ISSUES WAS AN OVERSIZED FEMORAL COMPONENT. FEMORAL COMPONENT AND INSERT REVISED WITH GMK-SPHERE COMPONENTS (FEMORAL COMPONENT FROM SIZE 3 TO SIZE 1, INSERT SAME THICKNESS, 10MM). PRIMARY SURGERY WAS LIKELY PERFORMED ON (B)(6) 2023, DETAILS ARE NOT AVAILABLE.

  Patient problems: Implant Pain

  MAUDE report 21774490 ↗

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