Endo-Model Modular Knee Prosthesis System 15-2951/25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575326037), received between Oct 29, 2024 and Nov 1, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NOTIFIED FROM REPRESENTATIVE J.C. THAT A PATIENT WITH A FUSION NAIL HAS LOOSENING OF THE IMPLANT; CONFIRMATION THAT THE FEMORAL STEM IS LOOSE IN THE PROXIMAL FEMUR. IMPLANTED ON (B)(6) 2023. POSSIBLE REVISION WITH A CUSTOM DEVICE.

  Patient problems: Joint Laxity

  MAUDE report 20589930 ↗
• InjuryOct 29, 2024Osseointegration Problem; Osseointegration Problem

  NOTIFIED BY J. C. THAT A PATIENT WITH A FUSION NAIL HAS LOOSENING OF THE IMPLANT. IMPLANTED ON (B)(6) 2023. CURRENTLY, NO EVENT DATE KNOWN. POSSIBLE REVISION WITH A CUSTOM DEVICE. UPDATED 2024-10-07: EVENT DATE ADDED, AS 2024-10-03, WHEN REPRESENTATIVE RECEIVED A CALL FROM DR. I.; CONFIRMATION THAT THE FEMORAL STEM IS LOOSE IN THE PROXIMAL FEMUR - PRODUCT NAME AND PRODUCT COMBINED WITH SECTIONS UPDATE; NO OTHER INFORMATION IS CURRENTLY AVAILABLE FOR THE PATIENT EXCEPT FOR THE DR. STATING THAT THE PATIENT IS OBESE. WAITING RESPONSE ON AVAILABILITY OP REPORT.[CUSTOMER].

  Patient problems: Aseptic loosening; Insufficient Information; Periprosthetic fracture

  MAUDE report 20554255 ↗