GMK Primary Total Knee System 02.07.1201LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030819841), received between Jan 4, 2018 and May 13, 2026 — classified as 5 injuries, 1 malfunction.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026No Apparent Adverse Event

  THE SURGEON EXPERIENCED DIFFICULTY INSERTING THE EFFICIENCY 10 MM LEFT INSERT INTO A SIZE 1 LEFT CEMENTED TIBIAL BASEPLATE, REQUIRING MULTIPLE ATTEMPTS. THE PATIENT ACHIEVED FULL EXTENSION WITH A ROM OF 120°, WITH NO TIGHTNESS ISSUES. DIFFICULTY WAS ALSO ENCOUNTERED WHEN INSERTING THE DEFINITIVE 10 MM POLYETHYLENE INSERT, LEADING TO DAMAGE TO ITS POSTERIOR ASPECT AFTER REPEATED ATTEMPTS. AN 11 MM INSERT WAS THEN TRIED, ALSO WITH MULTIPLE ATTEMPTS, AND WAS ULTIMATELY FORCEFULLY IMPACTED USING A TIBIAL IMPACTOR. THE PROCEDURE TIME WAS EXTENDED BY APPROXIMATELY 45 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160337 ↗
• InjuryJul 31, 2025Implant subsidence; Implant subsidence

  6 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN DUE TO COLLAPSE OF THE LATERAL TIBIAL BONE. DURING THE PRIMARY SURGERY, THE TIBIAL COMPONENT HAD BEEN SLIGHTLY UNDERSIZED, AND THE PATIENT HAD SOFT BONE. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT, AND IMPLANTED A STEM EXTENSION ALONG WITH TIBIAL AUGMENTS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 22673493 ↗
• InjuryMay 23, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19381855 ↗
• InjuryFeb 23, 2024Migration; Migration

  ABOUT 7 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, REVISION SURGERY HAS BEEN PERFORMED DUE TO TIBIAL SUBSIDENCE.

  Patient problems: Pain

  MAUDE report 18765773 ↗
• InjuryDec 15, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  REVISION SURGERY DUE TO TIBIAL TRAY FIXED CEMENTED SIZE 1 SUBSIDENCE AND KNEE INSTABILITY, AT ABOUT 2 YEARS 10 MONTHS AFTER THE PRIMARY. ALL COMPONENTS SUCCESSFULLY REVISED WITH COMPETITOR'S SYSTEM.

  Patient problems: Joint Laxity

  MAUDE report 18334828 ↗
• InjuryJan 4, 2018Device Slipped

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE TIBIAL BASEPLATE HAD SUBSIDED. THE SURGEON REVISED THE TIBIAL BASEPLATE AND THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7163357 ↗

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