ADVANCE® KSP11140Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684KSP111401), received between Apr 5, 2023 and Apr 5, 2023 — classified as 1 injury.

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 16, 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.

• InjuryApr 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ALLEGEDLY, PHYSICIAN PERFORMED A REVISION OF A TIBIAL IMPLANT ON (B)(6) 2022. A 12 MM BY 140 MM STEM WAS CONNECTED TO A SIZE 2 TRAY. THEY WERE IMPACTED TOGETHER WITH A SINGLE BLOW. THE PATIENT DID WELL INITIALLY BUT RETURNED WITH NOTING PAIN IN THE REGION OF THE TIBIA. HE RECALLED NO TRAUMA. X-RAYS SHOW THE STEM STARTING TO DISENGAGE FROM THE TRAY.

  Patient problems: Pain

  MAUDE report 16686140 ↗