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ADVANCE® KSP13140Recalls & reported problems

Microport Orthopedics Inc. · ADVANCE® CANAL FILLING STEM EXTENSION 14mm X 140mm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684KSP131401), 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

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Pain1

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, SURGEON HAD TO DO ADDITIONAL SURGERY ON A PATIENT BECAUSE THE FEMORAL COMPONENT AND THE STEM CAME UNCOUPLED. ADDITIONAL INFORMATION RECEIVED FROM SURGEON ON 8/17/2022: PATIENT HAD A PREVIOUS SUPRACONDYLAR FEMUR FRACTURE YEARS AGO WHICH HAD HEALED IN A VALGUS POSITION. THIS LED TO ARTHRITIS OF THE KNEE. BECAUSE OF THIS SITUATION WE CHOSE TO PERFORM A DISTAL FEMORAL OSTEOTOMY TO ADDRESS THE MALUNION AND A TOTAL KNEE ARTHROPLASTY TO ADDRESS THE ARTHRITIS. THE PLAN WAS THAT THE STEMMED IMPLANT SHOULD MAINTAIN THE CORRECTION GAINED BY THE OSTEOTOMY. THE PATIENT DID WELL INITIALLY BUT THEN NOTED INCREASING PAIN AND INCREASING VALGUS ANGULATION OF THE KNEE. X-RAYS SHOWED INCREASING VALGUS ALIGNMENT AND THE STEM WAS COMING UNCOUPLED FROM THE FEMORAL COMPONENT. ON (B)(6) 2022, SURGERY TO CORRECT THIS WAS A REDUCTION AND PLACEMENT OF A LATERAL LOCKING PLATE ON THE FEMUR TO MAINTAIN ALIGNMENT AND ALLOW HEALING OF THE OSTEOTOMY. THE FEMORAL COMPONENT AND THE STEM WERE LEFT IN PLACE. THE FEMORAL COMPONENT MAINTAINED ITS FIXATION ON THE DISTAL FRAGMENT AND THE STEM MAINTAINED ITS POSITION IN THE IM CANAL. THE ANGULATION OCCURRED AT THE CONNECTION BETWEEN THE TWO. SURGEON ALSO STATED:

    Patient problems: Pain

    MAUDE report 15355650 ↗

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

All Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.