GMK Primary Total Knee System 02.07.0520FUCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030818615), received between Aug 5, 2020 and Dec 15, 2022 — classified as 2 injuries.

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

Recent adverse event reports

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

• InjuryDec 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY, FEMUR AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15987240 ↗
• InjuryAug 5, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED FEMUR AND LINER (ONLY MEDACTA DEVICES INVOLVED). AN ANTIBIOTIC SPACER WAS IMPLANTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY 1 YEAR AFTER PRIMARY.

  Patient problems: Unspecified Infection

  MAUDE report 10366567 ↗

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