GMK Primary Total Knee System 02.07.2005LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030820236), received between Nov 27, 2018 and Jul 2, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Corroded” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED FEMORAL COMPONENT, POLY AND TIBIAL TRAY 9 YEARS AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10222797 ↗
• InjuryDec 18, 2018Corroded; Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO LOOSENING, ALL COMPONENTS HAVE BEEN REMOVED AFTER ABOUT 2 YEARS FROM PRIMARY. NO CEMENT HAS BEEN FOUND ON THE PROSTHESIS COMPONENT. THE FEMORAL COMPONENT HAS FEW COLOURED SPOTS (RUST). THE PRIMARY SURGERY HAS BEEN PERFORMED ON (B)(6) 2015 AND ON (B)(6) 2016 THE PATIENT HAD BEEN ALREADY REVISED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8173615 ↗
• InjuryNov 27, 2018Unstable

  THE PATIENT CALLED FDA TO REPORT THAT SINCE HE HAS BEEN IMPLANTED WITH A TOTAL KNEE IMPLANT, HE HAS HAD PAIN, DISCOMFORT AND LOSS OF RANGE OF MOTION; THE IMPLANT IS AT TEN PERCENT DEFLEXION. THE REPORTER HAS BEEN TOLD BY THREE HEALTHCARE "PROFESSIONAL" THAT HIS KNEE IMPLANT IS UNSTABLE AND EXPLORATORY SURGERY IS NEEDED. "THERE ARE NO RECORD" OF THE REVISION SURGERY BEING PERFORMED.

  Patient problems: Joint Disorder

  MAUDE report 8105811 ↗

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