ADVANCE® KPON38MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684KPON38MB1), received between Dec 23, 2019 and Aug 1, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

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.

• InjuryAug 1, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO POSSIBLE INFECTION OF HIS LEFT KNEE , PATELLA WAS SPINNING AND POLY SWAP.

  Patient problems: Failure to Anastomose; Unspecified Infection

  MAUDE report 10354041 ↗
• InjuryDec 23, 2019Unstable; Unstable

  ALLEGEDLY, INSTABILITY. THE AREA AROUND THE IMPLANTS WAS ALL BLACK,"POSSIBLE METALOSIS" CULTURES TAKEN. LATERAL CONDYLE POSTERIORLY HAD SIGNIFICANT WEAR ON POLY, FEMUR WORE THROUGH POLY AND WAS METAL ON METAL WITH BASE PLATE.

  Patient problems: No Information

  MAUDE report 9512347 ↗