GMK Primary Total Knee System 02.07.0510FUCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030818196), received between Feb 20, 2018 and Aug 3, 2026 — 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.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  The patient had knee instability and the cause is unknown. At about 14 years and 10 months post primary the surgeon upsized the insert and the surgery was completed successfully.

  Patient problems: Joint Laxity

  MAUDE report 50114119 ↗
• InjurySep 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 10 YEARS AND 4 MONTHS FROM THE PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15461308 ↗
• InjuryMar 15, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 8 YEARS 1 MONTH AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11482001 ↗
• InjuryFeb 13, 2020Appropriate Device Problem Term/Code Not Available

  ABOUT 1 YEAR POST PRIMARY REVISION SURGERY FOR SUSPECTED INFECTION. KNEE WASHOUT AND LINER EXCHANGE PERFORMED. INFECTION NOT CONFIRMED AFTER REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 9705358 ↗
• InjuryMay 8, 2018Unstable

  ABOUT 4 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A KNEE INSTABILITY. POLY SWAP PERFORMED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7494704 ↗
• InjuryFeb 20, 2018Loose or Intermittent Connection; Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY ABOUT TWO YEARS AFTER. THE PATIENT BECAME LOOSE OVER TIME. THE SURGEON SWAPPED THE LINER FROM A 10MM TO A 14MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7281746 ↗

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