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GMK Primary Total Knee System 02.07.2212LRecalls & reported problems

Medacta International SA · Femur Narrow cemented PS Left, size 2 · 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
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030820946), received between Sep 5, 2018 and Oct 14, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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
  • Device Appears to Trigger Rejection1
  • Loosening of Implant Not Related to Bone-Ingrowth1
  • Malposition of Device1

Patient problems

  • Insufficient Information1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 14, 2022Device Appears to Trigger Rejection; Loosening of Implant Not Related to Bone-Ingrowth; Device Appears to Trigger Rejection; Loosening of Implant Not Related to Bone-Ingrowth

    KNEE COMPONENTS LOOSENING (TIBIAL TRAY AND FEMUR) DUE TO NICKEL ALLERGY. REVISION SURGERY PERFORMED AT ABOUT 5 YEARS AND 4 MONTHS POST PRIMARY.

    Patient problems: Pain

    MAUDE report 15603079 ↗
  • InjuryOct 29, 2021Malposition of Device; Malposition of Device

    AT 2 YEARS AND 11 MONTHS AFTER THE PRIMARY MEDACTA SURGERY, ALL IMPLANTS WERE REVISED (WITH COMPETITOR) BECAUSE THE FEMUR COMPONENT WAS POSITIONED TOO POSTERIORLY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS TO COMPETITOR IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD A COMPETITOR IMPLANTS IMPLANTED DURING THE PRIMARY SURGERY AND HAD MEDACTA IMPLANTS IMPLANTED TO REVISE THE COMPETITOR IMPLANTS ON (B)(6) 2018.

    Patient problems: Insufficient Information

    MAUDE report 12717355 ↗
  • InjurySep 5, 2018Appropriate Device Problem Term/Code Not Available

    ABOUT 10 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR KNEE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 7845330 ↗

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

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Sources and updates

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