ADVANCE® KSP18100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684KSP181001), received between Oct 17, 2019 and Jun 26, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryJun 26, 2020Loss of Osseointegration; Detachment of Device or Device Component; Loss of Osseointegration; Detachment of Device or Device Component

  ALLEGEDLY, PATIENT WAS REVISED DUE TO FEMUR IMPLANT FRACTURED AT THE MORSE TAPER, THE TIBIAL IMPLANT WAS LOOSE, AND THERE WAS A DISSOCIATION OF THE TIBIAL STEM.

  Patient problems: No Information

  MAUDE report 10200800 ↗
• InjuryOct 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT FEMUR SUBSIDED SPIN 90 DEGREE DISLOCATED PATELLA DISLOCATED HINGE FEMUR WAS CUT ABOVE THE STEM AND ABOVE IMPLANTS WERE USED.

  Patient problems: Joint Dislocation

  MAUDE report 9203480 ↗