GMK Primary Total Knee System 02.07.0314FUCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030817236), received between Oct 18, 2017 and Jun 10, 2025 — 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.

• InjuryJun 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 12 YEARS AND 6 MONTHS, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE LINER (14MM) WITH A THICKER ONE (20MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22175021 ↗
• InjuryMay 16, 2022Appropriate Device Problem Term/Code Not Available

  AT 7 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (14MM TO 20MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 14405568 ↗
• InjuryOct 29, 2019Unstable

  REVISION SURGERY PERFORMED 2 YEARS AND 8 MONTHS AFTER THE PRIMARY DUE TO INSTABILITY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED INSERT 14MM WITH INSERT 20MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9249738 ↗
• InjuryAug 28, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY INSTABILITY AND THE CAUSE OF INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE MEDACTA TIBIAL INSERT U.C. FIX S.3 / 14 MM WITH A MEDACTA INSERT U.C. 17MM S3, 5 YEARS AND 6 MONTHS AND A HALF AFER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8938858 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem

  PATIENT CAME IN COMPLAINING OF INSTABILITY 2 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT BECAME UNSTABLE OVER TIME. THE SURGEON REVISED A 14MM INSERT FOR A 17MM INSERT SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8019246 ↗
• InjuryOct 18, 2017Stretched; Unstable

  THE PATIENT CAME IN COMPLAINING OF LAXITY. THE SURGEON DETERMINED THE SOFT TISSUE HAD STRETCHED OVER TIME. THE SURGEON SWAPPED A 14 MM UC INSERT FOR A 20 MM UC INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 6957331 ↗

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