GMK Primary Total Knee System 02.07.0212PSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030816581), received between Feb 15, 2018 and Sep 16, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (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.

• InjurySep 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 YEAR AND 6 MONTHS POST PRIMARY THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 23063083 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 9 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (12 TO 20 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17995655 ↗
• InjurySep 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17709128 ↗
• InjuryApr 22, 2022Break; Break

  THE PATIENT CAME IN REPORTING PAIN AFTER FALLING. ABOUT 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON OBSERVED THAT THE SCREW IN THE PATIENT'S POLY HAD BROKEN AND THAT THE POLY HAD PARTIALLY DISLOCATED. THE SURGEON REMOVED THE BROKEN SCREW AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. 3.5NM TORQUE LIMITER USED.

  Patient problems: Pain

  MAUDE report 14189887 ↗
• InjuryJul 1, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 4 YEARS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10216608 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN 3 YEARS AFTER PRIMARY. THE SURGEON REVISED THE LINER AND RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7442495 ↗
• InjuryFeb 15, 2018Break; Break

  WHILST TIGHTENING THE FIXATION SCREW, IT BROKE BEFORE THE TORQUE LIMITER WORKED. THE BROKEN SCREW WERE REMOVED (10 MIN OF DELAY). THE SCREW FRAGMENT EMBEDDED IN THE TIBIAL TRAY WAS NOT REMOVED. THE TIBIAL TRAY WAS LEFT IN PLACE WITHOUT THE SCREW. THE SURGEON HAD TO USE THE INSERT AS NO OTHER SIZE WAS SUITABLE FOR THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7273273 ↗

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