NovoKnee Total Knee System 3101-1202Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811382031809), received between Feb 2, 2023 and Feb 2, 2023 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  MEDWATCH FORM 3500 COMPLETED BY PATIENT. DESCRIPTION OF EVENT OR PROBLEM IN THE REPORTERS OWN WORDS TRANSCRIBED FROM REPORT NUMBER MW#5111413: I HAD A TOTAL KNEE REPLACEMENT ON "(B)(6) 2021" HAVE HAD SWELLING AND SEVERE PAIN. ON (B)(6) 2022 I WENT TO MY SURGEON AND HE DID X-RAYS, AND BLOOD WORK SAID EVERYTHING WAS FINE. THEN I WENT BACK TO HIM AGAIN (B)(6) 2022 AND HE DRAINED FLUID OFF MY KNEE AND ORDERED A BONE SCAN FOR (B)(6) 2022 I WAITED UNTIL MY NEXT APPOINTMENT WITH HIM ON (B)(6) 2022 HE THEN TOLD ME THAT MY KNEE WAS LOOSE AND I WOULD HAVE TO HAVE REVISION SURGERY. MY HUSBAND ASKED HIM WHAT ABOUT IF THIS DOESN'T WORK HE THEN SAID HE WOULD JUST HAVE TO AMPUTATE ABOVE THE KNEE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Pain

  MAUDE report 16286794 ↗