GMK Primary Total Knee System 02.07.0310SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030817083), received between Oct 20, 2021 and Jul 22, 2026 — classified as 4 injuries.

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

• InjuryJul 22, 2026Device Appears to Trigger Rejection

  AT ABOUT 7 YEARS AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE STD. 10MM S3 INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25904758 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE INSERT (10MM) WITH A THICKER ONE (17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16283996 ↗
• InjuryMay 27, 2022Defective Component

  AT 7 YEARS AND 11 MONTHS FROM PRIMARY, REVISION SURGERY FOR DEFECT IN PATELLO FEMORAL JOINT. LINER REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14522237 ↗
• InjuryOct 20, 2021Unstable; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE PAIN INSTABILITY IS UNKNOWN. ABOUT 5 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT STD. 10MM S3 WITH AN INSERT U.C. 14MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12665545 ↗

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