GMK Primary Total Knee System 02.07.2004LRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030820212), received between Jan 7, 2020 and Oct 21, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ABOUT 2 YEARS AND 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. ALL COMPONENTS REVISED TO GMK-REVISION SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 23349013 ↗
• InjuryJun 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 10 YEARS AND 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO THE LOOSENING OF FEMORAL AND PATELLA IMPLANTS AND SUBSIDENCE OF TIBIAL COMPONENT. THE CAUSE IS UNKNOWN. THE SURGEON REVISED TO REVISION SYSTEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17215115 ↗
• InjuryMay 18, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. AT 11 YEARS AND 5 MONTHS POST PRIMARY THE SURGEON REVISED THE FEMUR AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14427349 ↗
• InjuryAug 3, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT BROKE HIS MEDIAL COLLATERAL LIGAMENTS (CAUSE IS UNKNOWN) THEREFORE THE IMPLANTED PROSTEHSIS WAS NOT STABLE ANYMORE. 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON DECIDED TO CHANGE THE PROSTHESIS TO A GMK HINGE.

  Patient problems: Damage to Ligament(s)

  MAUDE report 12265697 ↗
• InjuryDec 22, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 7 YEARS AND 10 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11053919 ↗
• InjuryJul 17, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN AFTER 7 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO AN ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND TIBIAL TRAY. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10288183 ↗
• InjuryJan 7, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 YEARS AND 4 MONTHS AFTER PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY, FEMORAL COMPONENT AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9557477 ↗

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