Endo-Model Modular Knee Prosthesis System 15-2964/02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575205875), received between Jul 25, 2023 and Jul 27, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE MOST RECENT FOLLOW-UP VISIT NOTE DATED (B)(6) 2023 INDICATES THAT THE PATIENT HAS DISTAL FEMUR PAIN WITH RADIOGRAPHIC STUDIES SHOWING LOOSENING OF THE FEMORAL CEMENT MANTLE AND STEM. [CUSTOMER].

  Patient problems: Bone Shedding Debris; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 17403279 ↗
• InjuryJul 25, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THIS PATIENT HAD THESE DEVICES IMPLANTED DURING A REVISION SURGERY ON (B)(6) 2023. [THE PREVIOUS FEMORAL COMPONENTS WERE A COMMERCIALLY AVAILABLE POREX FEMUR AND STEM AND CUSTOM-COATED POREX FEMORAL AUGMENTS (COMP-051) IMPLANTED (B)(6) 2022 AND THE REVISION OF THESE COMPONENTS ON (B)(6) 2022 HAS BEEN PREVIOUSLY REPORTED IN LINKBIO COMPLAINT (B)(4). THE PATIENT'S FOLLOW-UP VISIT NOTES WERE SENT TO LINKBIO ON (B)(6) 2023. THE MOST RECENT FOLLOW-UP VISIT NOTE DATED (B)(6) 2023 INDICATES THAT THE PATIENT HAS DISTAL FEMUR PAIN WITH RADIOGRAPHIC STUDIES SHOWING LOOSENING OF THE FEMORAL CEMENT MANTLE AND STEM, WHICH DR. M THINKS MAY BE RESULTING FROM THE POLYETHYLENE AUGMENT THAT SHE HAS ON THE FEMORAL SIDE. DR. MAALE SEES NO PROBLEMS ON THE TIBIAL SIDE. DR. M PLANS TO REVISE THE FEMORAL SIDE WITH A CUSTOM DESIGN.

  Patient problems: Joint Laxity

  MAUDE report 17390907 ↗