GMK Primary Total Knee System 02.07.1206LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030819940), received between May 16, 2019 and Dec 9, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 4 YEARS AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN, DUE TO A SUBSIDED TIBIAL TRAY. THE SURGEON REVISED ALL IMPLANTS AND CONVERTED THE PATIENT FROM A SPHERE TO HINGE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 20877871 ↗
• InjuryFeb 7, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18657235 ↗
• InjuryApr 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING REPORTED KNEE PAIN. THE SURGEON ORDERED A CT SCAN WHICH APPEARED THE COMPONENTS WERE LOOSE. WHILE PERFORMING THE REVISION, IT WAS CONFIRMED THAT ALL THREE CEMENTED COMPONENTS WERE LOOSE (TIBIA, FEMUR AND PATELLA). AT ABOUT 2 YEARS FROM PRIMARY THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16768424 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 MONTHS FROM PRIMARY SURGERY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14160016 ↗
• InjuryMay 16, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2017 AND SHE WAS ALREADY REVISED ON (B)(6) 2017 DUE TO PAIN CAUSED FROM FALLING: THE SURGEON REVISED THE FEMORAL COMPONENT AND POLY (MDR 2017-00827). ABOUT 1 YEAR AND 4 MONTHS AFTER THAT FIRST REVISION, THE PATIENT HAD ANOTHER REVISION SURGERY DUE TO RUPTURED PATELLA TENDON. FEMORAL AND TIBIAL COMPONENTS SWAPPED SUCCESSFULLY.

  Patient problems: Injury

  MAUDE report 8615711 ↗

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