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GMK Primary Total Knee System 02.07.0420FUCRecalls & reported problems

Medacta International SA · Tibial insert UC fixed 20mm, size 4 · 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
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030818035), received between Jul 6, 2022 and Jul 6, 2022 — classified as 1 injury.

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

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Loose or Intermittent Connection1

Patient problems

  • Joint Laxity1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 6, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

    THE PATIENT HAD A PRIMARY KNEE SURGEON ON (B)(6) 2015. ON (B)(6) 2017, THE PATIENT FELL AND CAME IN REPORTING LAXITY. THE SURGERY SWAPPED THE 12MM POLY FOR A 17MM POLY. ON (B)(6) 2017, THE PATIENT WAS REVISED AGAIN. THE PATIENT FELL AND CAME IN REPORTING LAXITY. THE SURGEON SWAPPED THE 17MM INSERT FOR A 20MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT AND TIBIAL TRAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Joint Laxity

    MAUDE report 14927433 ↗

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

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