GMK Primary Total Knee System 02.07.0214FUCRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030816659), received between Jul 21, 2017 and Jul 15, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Unstable” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 2 YEARS AND 6 MONTHS, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL PRIMARY COMPONENTS AND REVISED TO A GMK REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22506265 ↗
• InjuryApr 30, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19210982 ↗
• InjuryJan 12, 2021Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY 4 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON UPSIZED THE INSERT U.C. 14MM S2 TO AN INSERT U.C. 20MM S2 TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11153621 ↗
• InjuryJul 4, 2019Loose or Intermittent Connection; Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 4 YEARS AND 3 MONTHS AFTER THE PRIMARY DUE TO INSTABILITY CAUSED BY KNEE LAXITY. THE SURGEON PERFORMED A LINER SWAP (SIZE 14MM HAS BEEN EXCHANGED WITH 20 MM) AND RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 8762587 ↗
• InjuryMar 27, 2019Loose or Intermittent Connection

  ABOUT 2 YEARS AND THREE MONTHS AFTER PRIMARY, THE SURGEON REVISED THE PATIENT FOR INSTABILITY DUE TO KNEE LAXITY. THE CAUSE OF LAXITY IS UNKNOWN. THE SURGEON SWAPPED ALL THE HARDWARE SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8456538 ↗
• InjuryMay 8, 2018Loose or Intermittent Connection; Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY 8 MONTHS AFTER PRIMARY AND THE 12MM INSERT WAS REVISED WITH A 14MM. THE PATIENT BECAME LOOSE OVER TIME. (MDR 2016-00539) THE PATIENT CAME IN AGAIN 1 YEAR AND 7 MONTHS LATER, COMPLAINING OF ANTERIOR KNEE PAIN. THE PATIENT WAS A LITTLE LOOSE, SO THE 14MM POLY WAS REPLACED WITH A 17MM AND RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7494739 ↗
• InjuryMar 9, 2018Device Dislodged or Dislocated

  THE PATIENT CAME IN DUE TO DISLOCATION. THE SURGEON REVISED THE 14MM INSERT WITH A 17MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 7326624 ↗
• InjuryJul 21, 2017Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON CONFIRMS INSTABILITY IN BOTH FLEXION AND EXTENSION. THE SURGEON REVISED THE INSERT AS PLANNED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 6731750 ↗

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