GMK Primary Total Knee System 02.07.2003RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030820205), received between Sep 26, 2017 and Sep 10, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 13 YEARS AND 4 MONTHS POST PRIMARY THE SURGEON REVISED THE FEMUR AND POLY TO REVISION COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20180518 ↗
• InjuryDec 16, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ABOUT 10 YEARS AFTER THE PRIMARY SURGERY, ALL COMPONENTS HAVE BEEN REVISED DUE TO TIBIAL AND FEMORAL COMPONENTS MOBILIZATION. THE PATIENT PREVIOUSLY UNDERWENT REVISION SURGERY WHERE THE INSERT WAS REVISED AND THE PATELLA BONE WAS RESURFACED.

  Patient problems: Pain

  MAUDE report 15996267 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem

  ABOUT 6 YEARS AND 9 MONTHS AFTER PRIMARY REVISION SURGERY FOR INFECTION. ALL KNEE HARDWARE REVISED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8789420 ↗
• InjurySep 26, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. ON (B)(6) 2017 ANOTHER SURGEON REMOVED THE IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. ON (B)(6) 2017 THE SURGEON REVISED THE SPACER AND IMPLANTED MEDACTA HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6893682 ↗

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