GMK Primary Total Knee System 02.07.2204LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030820847), received between Aug 23, 2017 and Dec 1, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

• InjuryDec 1, 2020Loose or Intermittent Connection

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AFTER 4 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN, AND X-RAYS WERE TAKEN. RABIOLUCENCIES WERE SEEN WHEN OBSERVING THE X-RAYS. DURING THE REVISION SURGERY, IT WAS OBSERVED THAT THE FEMUR AND TIBIA WERE LOOSE AND THERE WAS NO CEMENT PRESENT ON THE IMPLANTS. THE SURGEON REVISED THE FEMUR, INSERT AND TIBIA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Pain

  MAUDE report 10928290 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED DUE TO INFECTION, 4 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE FEMORAL AND THE FULL-PE PS TIBIAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY, THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 8631631 ↗
• InjuryNov 16, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED DUE TO SIGNS OF INFECTION. THE SURGEON REVISED THE TIBIAL COMPONENT, FEMUR AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7037277 ↗
• InjuryAug 23, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS ENTEROCOCCUS. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE TIBIAL COMPONENT AND THE FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6812709 ↗

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