GMK Primary Total Knee System 02.07.2006LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030820250), received between Aug 18, 2017 and Mar 26, 2026 — 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.

• InjuryMar 26, 2026Device Appears to Trigger Rejection

  AT ABOUT 15 YEARS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO A TOTAL KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA PRODUCTS FROM THE PRIMARY SURGERY TO COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24700708 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE ON (B)(6) 2017. THE SURGEON IMPLANTED NEW HARDWARE AS PLANNED ON (B)(6) 2017. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6803599 ↗

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