GMK Primary Total Knee System 02.07.1201RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030819858), received between Jul 11, 2018 and Jun 4, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION FOR TIBIAL TRAY FIXED CEMENTED LOOSENING AT ABOUT 2 YEARS AND 7 MONTHS POST PRIMARY. TIBIAL TRAY REVISED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 22140919 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 18805922 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17215661 ↗
• InjuryJun 19, 2019Loose or Intermittent Connection

  REVISION SURGERY PERFORMED AFTER 11 MONTHS FROM THE PRIMARY SURGERY DUE TO TIBIAL LOOSENING. TIBIAL TRAY AND INLAY HAVE BEEN REMOVED.

  Patient problems: Joint Disorder

  MAUDE report 8710810 ↗
• InjuryJul 11, 2018Device Slipped

  REVISION SURGERY PERFORMED DUE TO TIBIAL TRAY LOOSENING, 9 MONTHS AFTER SURGERY.

  Patient problems: No Code Available

  MAUDE report 7677481 ↗

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