Endo-Model Modular Knee Prosthesis System 15-8521/06Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575383191), received between Jan 16, 2023 and Jan 17, 2024 — classified as 2 injuries.

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. 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.

• InjuryJan 17, 2024Naturally Worn; Positioning Problem; Naturally Worn; Positioning Problem

  (B)(6). PATIENT PRESENTED WITH DIFFICULTY WALKING, COMBINED WITH CLICKING AND LOCKING IN THE RIGHT KNEE SUBSEQUENT TO A ON (B)(6) 2022 TKA (REVISION). X-RAYS SHOWS SOME OFFSET OF FEMUR WITH RESPECT TO THE TIBIAL PLATEAU. BOTH THE FEMORAL AND TIBIAL COMPONENTS APPEAR SECURELY FIXED ON X-RAY. REVISION SURGERY IS SCHEDULED FOR ON (B)(6) 2024. ADDITIONAL INFORMATION WILL BE UPDATED AFTER SURGERY. UPDATE 03/13/2024: (B)(6) CONFIRMED THAT THE REVISION PLANNED FOR ON (B)(6) 2024 TOOK PLACE. DR. (B)(6) REPLACED THE FEMORAL COMPONENT AND TIBIAL POLY. THE EXPLANTED DEVICES WERE NOT RELEASED BY THE HOSPITAL. A REQUEST HAS BEEN MADE FOR THE OPERATIVE REPORT. (B)(6) NOTED THAT THIS PATIENT HAS NO EXTENSOR MECHANISM. INTRAOPERATIVELY, HE OBSERVED THAT THE POLYETHYLENE THIMBLE IN THE POST HAD WORN THROUGH ON THE ANTERIOR SIDE SEEMINGLY FROM THE SHEAR FORCE OF THE FEMUR ON THE POST RELATED TO LACK OF EXTENSOR MECHANISM. NO PHOTOS WERE AVAILABLE. ON (B)(6) 2024, USAGE FORM PROVIDED.[CUSTOMER].

  Patient problems: Failure of Implant

  MAUDE report 18525512 ↗
• InjuryJan 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DUE TO EXCESSIVE SWELLING, DR. (B)(6) UNDERTOOK A REVISION SURGERY ON THE PATIENT ON (B)(6) 2023 TO DEBRIDE/WASH OUT THE JOINT AND REPLACE THE PLATEAU, AND DISCOVERED CONDYLE CAP FROM THE FEMORAL COMPONENT CONDYLAR REPLACEMENT LOOSE IN THE JOINT SPACE, SITTING IN FRONT OF THE KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16172828 ↗