Endo-Model Modular Knee Prosthesis System 15-2950/04Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575319015), received between Jan 9, 2025 and Jan 9, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryJan 9, 2025Fracture; Fracture

  SIDE: LEFT. DIAGNOSIS: FEMORAL SHAFT FRACTURE WITH POSSIBLE METALLOSIS? REVISION OF THE CEMENTED 120MM FEMORAL SHAFT, THE SIZE M FEMORAL COMPONENT, THE SIZE 3 FEMORAL SEGMENT AND THE TIBIAL PLATEAU. THE TIBIA WAS FIRMLY ANCHORED. THE FEMORAL SHAFT IS BROKEN OR FRAGMENTED AT THE DISTAL END OR AT THE ATTACHMENT TO THE FEMORAL CONE IN SEVERAL PLACES. REMOVAL OF THE SHAFT WAS DIFFICULT BECAUSE NO LOOSENING WAS DETECTABLE. THE HOLE FOR SCREW FIXATION WAS WIDENED WITH A DRILL TO ALLOW A REMOVAL HOOK TO BE ATTACHED AND THE STEM TO BE REMOVED WITH A HAMMER. AFTER REMOVAL OF THE STEM, IRRIGATION AND INSERTION OF LOW-VISCOSITY CEMENT, THE FOLLOWING WAS IMPLANTED: FEMORAL COMPONENT 15-2817/12 REPLACEMENT PLATEAU 150027/15 MODULAR STEM 15-2950/06 FEMORAL SEGMENT 15-2978/02 A VERY SATISFACTORY RESULT WAS ACHIEVED.[CUSTOMER].

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 21111586 ↗