ADVANCE® KSP14100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684KSP141001), received between Mar 17, 2020 and Sep 16, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(4), SIDE: L, GENDER: F.

  Patient problems: Unspecified Infection

  MAUDE report 23062513 ↗
• InjuryJul 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ALLEGEDLY, SURGERY FAILED BECAUSE THE TIBIAL COMPONENT OF THE SYSTEM'S JOINT PROSTHESIS SEPARATED , NECESSITATING ITS REVISION, REMOVAL AND REPLACEMENT. ADDITIONAL INFORMATION RECEIVED ON 06/15/2020: ADDING PATIENT AGE AND DATE OF BIRTH. ADDITIONAL INFORMATION RECEIVED ON 07/01/2020: UPDATE OF PRODUCT AND LOT IDS, DATE OF SURGERY AND ADDING INCIDENT DATE.

  Patient problems: No Information

  MAUDE report 10229533 ↗
• InjuryMar 17, 2020Break; Break

  ALLEGEDLY, THE RESURFACING FEMORAL AND STEM EXTENSION BROKE AT JUNCTION. REVISED TO DISTAL GUARDIAN ORIGINAL SURGERY.

  Patient problems: No Information

  MAUDE report 9844953 ↗