Endo-Model Modular Knee Prosthesis System 15-8521/08Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575383214), received between Oct 25, 2024 and Oct 28, 2024 — 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.

• InjuryOct 28, 2024Fracture; Malposition of Device; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Malposition of Device; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  RECEIVED INFORMATION REGARDING LOOSENING COMPONENTS FOR A PROCEDURE COMPLETED ON (B)(6) 2023. NO EVENT DATE PROVIDED. AWAITING ADDITIONAL INFORMATION. UPDATED (B)(6) 2024: REVISION SURGERY OCCURRED ON (B)(6) 2024. IT WAS CONFIRMED TO BE A LOOSENING OF THE HINGE . THE ENTIRE FEMORAL CONSTRUCT WAS REMOVED, THE TIBIA WAS LEFT. AS NOTED IN REVISION SURGERY PER (B)(6)., MOTION WAS ASSESSED AND FOUND TO BE TOO MUCH AXIAL AND VARUS/VALGUS MOTION WITH THE HINGE. THE TIBIAL PLATEAU WAS FIRMLY SCREWED INTO THE TIBIA. THE THIMBLE WAS WORN DOWN AND THE DOCTOR WONDERED IF THE POLY LOCKING DETAIL HAD WORN DOWN ON ONE SIDE. SEE ALL IMAGES PROVIDED. IT WAS ALSO NOTED AT THE PROCEDURE THAT THE PROXIMAL TIBIA WAS FRACTURED AND HEALED.[CUSTOMER]

  Patient problems: Extraskeletal ossification; Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 20544090 ↗
• InjuryOct 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY OCCURRED ON (B)(6) 2024 FOR A FEMORAL COMPONENT THAT WAS ORIGINALLY IMPLANTED ON (B)(6) 2023. THE ENTIRE FEMORAL CONSTRUCT WAS REMOVED AND REPLACED. IT WAS NOTED THAT THE HINGE OF THE FEMORAL COMPONENT WAS LOOSE. IT WAS ALSO NOTED THAT THE PROXIMAL TIBIA WAS FRACTURED AND HAD HEALED.

  Patient problems: Joint Laxity

  MAUDE report 20537171 ↗