GMK Primary Total Knee System 02.07.0312FUCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030817137), received between Aug 3, 2017 and Dec 2, 2025 — classified as 6 injuries.

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

• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT PRIMARY KNEE SURGERY. ON (B)(6) 2017, AFTER A FALL, THE PATIENT PRESENTED WITH LAXITY, AND THE 12 MM INSERT WAS REVISED TO A 17 MM INSERT. ON (B)(6) 2017, FOLLOWING ANOTHER FALL AND RECURRENT LAXITY, THE INSERT WAS REVISED FROM 17 MM TO 20 MM. ON (B)(6) 2022, THE PATIENT PRESENTED WITH INSTABILITY OF UNKNOWN CAUSE, AND THE SURGEON REVISED THE INSERT AND TIBIAL TRAY (B)(4). ON (B)(6) 2025, THE PATIENT PRESENTED WITH ANTERIOR KNEE PAIN AND LAXITY OF UNKNOWN CAUSE, AND THE SURGEON REVISED THE INSERT (FROM 12 MM TO 14MM) AND RESURFACED THE PATELLA.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 23690784 ↗
• InjuryJun 25, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. 4 YEARS AND 9 MONTHS AFTER PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10193998 ↗
• InjuryJul 3, 2019Unstable

  ON (B)(4) 2019 WE WERE INFORMED OF A REVISION SURGERY PERFORMED AFTER 6 YEARS AND 7 MONTHS (ON (B)(6) 2019) AFTER THE PRIMARY DUE TO KNEE INSTABILITY. THE SURGEON PERFORMED A POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8757354 ↗
• InjuryApr 5, 2018Device Slipped

  THE PATIENT WAS REVISED DUE TO INSTABILITY AFTER TWO YEARS FROM PRIMARY. THE PATIENT LOOSENED OVER TIME. THE SURGEON REVISED THE 12MM INSERT FOR A 17MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7398590 ↗
• InjuryFeb 28, 2018Unstable

  THREE YEARS AND 3 MONTHS AFTER PRIMARY FOR AN INSTABILITY CASE THE SURGEON REVISED THE 12MM INSERT IMPLANTING A 17MM INSERT.

  Patient problems: Joint Disorder

  MAUDE report 7302115 ↗
• InjuryAug 3, 2017Loose or Intermittent Connection

  WHILE THE PATIENT WAS EXERCISING, SHE FELT LOOSE. THE SURGEON REVISED THE 12MM INSERT WITH A 17MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: No Information

  MAUDE report 6763325 ↗

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