GMK SpheriKA Cementless 02.12.KA176RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630345799395), received between Oct 20, 2025 and Dec 24, 2025 — classified as 2 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

Recent adverse event reports

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

• InjuryDec 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 WEEK FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, POLY AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23886583 ↗
• InjuryOct 20, 2025Failure to Osseointegrate; Failure to Osseointegrate

  THE PATIENT CAME IN PRESENTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON ORIGINALLY PLANNED A LINER SWAP AND PATELLA REPLACEMENT, HOWEVER DURING THE REVISION THE SURGEON SUSPECTED THE FEMUR OF BEING LOOSE. SO, AT ABOUT 7 MONTHS FROM PRIMARY THE SURGEON REVISED THE GMK-SPHERIKA IMPLANTS TO HINGE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23334294 ↗