GMK Primary Total Knee System 02.07.2206RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030820892), received between Mar 18, 2020 and Apr 15, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2020Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED DUE TO LOOSENING OF THE ENTIRE PROSTHESIS, PATELLA AS WELL, AFTER ABOUT 5 YEARS FROM THE PRIMARY SURGERY. ALL COMPONENTS HAVE BEEN REMOVED.

  Patient problems: Joint Disorder

  MAUDE report 9961874 ↗
• InjuryMar 18, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 8 YEARS AFTER PRIMARY SURGERY, FOR A POST-OP APPOINTMENT, AND THE SURGEON DETERMINED THAT THE PATIENT'S BONE SCAN SHOWED LOOSE IMPLANTS. DURING THE REVISION SURGERY, THE SURGEON OBSERVED THAT THE CEMENT DID NOT BOND TO ANY OF THE IMPLANTS. THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9846881 ↗

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