ADVANCE® KSP13100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684KSP131001), received between Sep 5, 2022 and Sep 5, 2022 — 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. How this data works · Data updated Oct 13, 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.

• InjurySep 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ALLEGEDLY, WHEN REVISING A FEMORAL COMPONENT WITH A STEM, SURGEON REMOVED THE FEMORAL COMPONENT BUT THE STEM REMAINED IN THE FEMUR AND HAD TO BE REMOVED SEPARATELY. ADDITIONAL INFORMATION RECEIVED FROM SURGEON ON 8/17/2022: "PATIENT HAD PRIOR PARTIAL KNEE ARTHROPLASTY THAT HAD LOOSENED. REVISION TO TOTAL KNEE WAS PERFORMED INCLUDING USE OF STEMS TO PROVIDE MORE STABILITY TO IMPLANTS. PATIENT HAD DIFFICULTY REGAINING FULL EXTENSION. POSTERIOR CAPSULAR RELEASE WAS PERFORMED. LIMITED EXTENSION PERSISTED, SO ON (B)(6) 2018 REVISION OF THE FEMORAL COMPONENT WAS PERFORMED. THE FEMORAL COMPONENT WAS REMOVED AND THE STEM STAYED IN PLACE IN THE IM CANAL AND HAD TO BE REMOVED SEPARATELY." SURGEON ALSO STATED: "THE CONNECTION BETWEEN THE FEMORAL COMPONENT AND A STEM HAVE NOT MAINTAINED A STRONG CONNECTION. I HAVE A FRIEND WHO IS AN ENGINEER AND USED TO OWN A MECHANICAL TESTING COMPANY. HE STATES A MORSE TAPER IS A VERY RELIABLE CONNECTION. IT SHOULD NOT COME APART EASILY AND SOMETIMES REQUIRES SPECIAL TOOLS TO DISENGAGE THE JOINT."

  Patient problems: Insufficient Information

  MAUDE report 15355756 ↗