GMK Total Knee System 02.12.KA07LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630345716156), received between Jan 10, 2024 and Apr 30, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 16, 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.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY DUE TO A LOOSE FEMUR. THE SURGEON OBSERVED THAT SOME OF THE CEMENT USED TO ATTACH THE FEMUR IN THE PRIMARY SURGERY DID NOT ADHERE COMPLETELY. THE SURGEON REVISED THE GMK-SPHERIKA S7 FEMORAL COMPONENT TO A GMK-REVISION S4 FEMORAL COMPONENT WITH AUGMENTS AND REVISED THE GMK-SPHERIKA 10MM INSERT TO A SEMICONSTRAINED 12MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain; Joint Laxity

  MAUDE report 25039774 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND EXPLANTED THE FEMORAL COMPONENT, TIBIAL TRAY AND INSERT. THE SURGEON IMPLANTED TEMPORARY SPACERS AS PART OF THE 2-STAGE INFECTION PROTOCOL. THE SURGERY WAS COMPLETED SUCCESSFULLY. PERMANENT IMPLANTS WILL BE IMPLANTED AT A LATER DATE.

  Patient problems: Medical device site infection

  MAUDE report 18484051 ↗