GMK Primary Total Knee System 02.07.0410PSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030817649), received between Oct 27, 2017 and Jul 14, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF A FALL OR TRAUMA. AT ABOUT 1 YEAR AND 3 MONTHS POST PRIMARY THE SURGEON REVISED THE PS INSERT FROM A 10MM TO A 12MM TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25813735 ↗
• InjuryJul 3, 2025Positioning Problem; Migration; Positioning Problem; Migration

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE SCREW FROM THE POLY WAS FLOATING IN THE KNEE. IT IS UNKNOWN HOW THIS OCCURRED. ABOUT 11 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394391 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR KNEE STIFFNESS AT ABOUT 4 MONTHS FROM PRIMARY. ALL DEVICES WERE REVISED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 18111209 ↗
• InjuryJul 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 3 YEARS AND 1 MONTH POST PRIMARY DUE TO INFECTION, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17387947 ↗
• InjuryMar 14, 2018Unstable

  ABOUT 1 YEAR AND 2 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A KNEE INSTABILITY. THE SURGEON SWAPPED THE INSERT FROM A 10MM TO 14MM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7338223 ↗
• InjuryOct 27, 2017Device Issue; Device Issue

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE SCREW HAD BACKED OUT OF THE POLY. THE SURGEON SWAPPED THE POLY AS PLANNED, THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 6983092 ↗

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