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GMK Primary Total Knee System 02.07.0517PSFRecalls & reported problems

Medacta International SA · Tibial insert PS fixed 17mm, size 5 · Class 2 · Implant

All models of GMK Primary Total Knee System (99)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030818547), received between Dec 11, 2018 and Feb 11, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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

Device problems

  • Activation, Positioning or Separation Problem1
  • Microbial Contamination of Device1

Patient problems

  • No Known Impact Or Consequence To Patient1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 11, 2020Microbial Contamination of Device

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 9693705 ↗
  • MalfunctionDec 11, 2018Activation, Positioning or Separation Problem

    DURING THE PRIMARY KNEE SURGERY, THE SURGEON WAS UNABLE TO ENGAGE THE TIBIAL INSERT SCREW INTO THE TIBIAL BASEPLATE. THE SURGEON CLOSED UP THE PATIENT WITHOUT THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8150509 ↗

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

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

All Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page