GMK Primary Total Knee System 02.07.2205LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030820861), received between Nov 14, 2018 and Feb 10, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2022Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION OF ALL COMPONENTS (TIBIA, INLAY, FEMUR, EXCEPT PATELLA RESURFACING) 4 YEARS AFTER THE PRIMARY SURGERY IMPLANT DUE TO INSTABILITY.

  Patient problems: Insufficient Information

  MAUDE report 13506095 ↗
• InjuryJun 10, 2020Malposition of Device; Malposition of Device

  REVISION SURGERY PERFORMED DUE TO KNEE PAIN 6 YEARS AFTER THE PRIMARY SURGERY. THE KNEE WAS UNSTABLE IN EXTENSION, FLEXION AND MEDIAL ROTATION.

  Patient problems: Joint Disorder

  MAUDE report 10137746 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO INFECTION 3 MONTHS AFTER THE PRIMARY. THE CURRENT PATHOGEN IS UNKNOWN. ALL HARDWARE WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 8069020 ↗

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