GMK Primary Total Knee System 02.07.0312PSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630030817168), received between Sep 7, 2017 and Apr 2, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Fracture

  THE SCREW OF THE POSTERIOR-STABILIZED INSERT FRACTURED DURING TIGHTENING WITH THE TORQUE LIMITER (REPORTED USE OF A 3.5 NM TORQUE LIMITER). THE SCREW HEAD DETACHED, WHILE THE REMAINING FRAGMENT STAYED INSIDE THE INSERT. THE PROCEDURE WAS COMPLETED WITHOUT REMOVING THE RETAINED PORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762680 ↗
• InjuryFeb 26, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD A KNEE REVISION DUE TO INFECTION. DURING THE SURGEON THE FEMUR WAS FOUND SEPTIC LOOSEN. ALL DEVICES REVISED SUCCESSFULLY AT ABOUT 7 YEARS AND 3 MONTHS POST PRIMARY.

  Patient problems: Medical device site infection

  MAUDE report 24455600 ↗
• InjuryMar 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 8 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16596969 ↗
• InjuryNov 26, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING AN INABILITY TO ACHIEVE FULL FLEXION. THE SURGEON CUT MORE PROXIMAL TIBIA AND REVISED THE GMK TIBIAL TRAY CEMENTED RIGHT S3 WITH A REV. TIBIAL TRAY RIGHT S2, AND REVISED THE INSERT P.S. 12MM S3 WITH A INSERT P.S. 17MM S2 AND ADDED AN EXTENSION STEM 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 10910301 ↗
• InjuryApr 30, 2019Loose or Intermittent Connection; Unstable

  THE PATIENT CAME IN, MORE THAN FIVE YEARS AFTER PRIMARY SURGERY, COMPLAINING OF INSTABILITY WHICH WAS CAUSED BY LAXITY. THE SURGEON REVISED THE 12MM POLY WITH A 17MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 8564989 ↗
• InjuryDec 27, 2018Patient-Device Incompatibility

  ABOUT 1 YEAR AND 9 MONTHS AFTER PRIMARY THE SURGEON REVISED SUCCESSFULLY THE 12MM INSERT WITH A 17MM ONE. THE PATIENT WAS COMPLAINING KNEE PAIN AND MID FLEXION INSTABILITY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8199389 ↗
• InjuryMar 22, 2018Unstable

  THE SURGEON NOTIFIED SALES REPRESENTATIVE ON (B)(6) 2018 THAT THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THE PATIENT WAS LOOSE IN FLEXION AND EXTENSION. THE SURGEON PLANS TO REVISE THE POLY ON (B)(6) 2018. ON (B)(6) 2018 WE WERE INFORMED THAT THIS CASE IS CANCELLED UNTIL FURTHER NOTICE. THE PATIENT HAS BEEN SMOKING AND THUS CANNOT PERFORM SURGERY.

  Patient problems: Joint Disorder

  MAUDE report 7362185 ↗
• InjurySep 13, 2017Migration or Expulsion of Device

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE SCREW BACKED OUT OF THE TIBIAL INSERT. THE SURGEON WASHED OUT THE KNEE, SWAPPED THE POLY AND EXPLANTED THE SCREW. THE SURGEON USED THE SCREW WITH THE NEW POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 6860923 ↗
• InjurySep 7, 2017Loose or Intermittent Connection

  REVISION OF THE LINER (LEFT KNEE) BECAUSE THE KNEE WAS LOOSE, OVERSTRETCHED, AND PAINFUL. LINER CHANGED FROM 12MM TO 20MM. THE EXPLANTED LINER WAS SENT TO THE SEROLOGY LABORATORY.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6847610 ↗

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