Endo-Model Modular Knee Prosthesis System 15-2814/02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026575316281), received between Feb 13, 2024 and Sep 13, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. May 22, 2024Class IIOpen, Classified

   Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

   Z-2410-2024 · Root cause: Process design · Recall details · FDA record ↗

2. May 24, 2022Class IIOpen, Classified

   There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.

   Z-1377-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Separation Failure; Separation Failure

  NOTIFIED BY T. A. THAT ON (B)(6) 2024, DR. (B)(6) WAS PERFORMING A REVISION USING THE ENDO W HINGE SYSTEM AND 2 LOTS OF TIBIAL AUGMENTS WERE OPENED AND EACH HAD A SCREW THAT WOULD NOT DISENGAGE. CEMENT WAS THEN USED TO SET THE AUGMENT IN PLACE. ON PART 15-2814/02 LOT 230619/2153, ONLY THE LATERAL SCREW COULD BE REMOVED. ON PART 15-2814/02 LOT 230703/1306 , ONLY THE MEDIAL SCREW COULD BE REMOVED. IT WAS ALSO NOTED THAT THE SCREWS THAT WERE REMOVED WERE VERY DIFFICULT TO GET OUT, AND A 2.5 SCREWDRIVER WAS BROKEN IN THE PROCESS. LOT 230703/1306 WAS CEMENTED INTO PLACE. WAITING INFORMATION ON RETURN OF LOT 230619/2153. CORRECTION 2024-08-21:INITIAL PN / LOT NUMBER INFORMATION RECEIVED WAS INACCURATE. I HAVE RECEIVED THE COMPLAINT SAMPLE AND IT IS LOT 230703/1306, SO LOT 230619/2153 IS THE PART THAT HAS BEEN IMPLANTED, WHICH WAS VERIFIED BY THE REPRESENTATIVE. COMPLAINT SAMPLE WILL BE SHIPPED FOR INVESTIGATION. [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211313 ↗
• MalfunctionSep 11, 2024Separation Failure; Separation Failure

  NOTIFIED BY (B)(6). THAT ON (B)(6) 2024, DR. (B)(6). WAS PERFORMING A REVISION USING THE ENDO W HINGE SYSTEM AND 2 LOTS OF TIBIAL AUGMENTS WERE OPENED AND EACH HAD A SCREW THAT WOULD NOT DISENGAGE. CEMENT WAS THEN USED TO SET THE AUGMENT IN PLACE. ON PART 15-2814/02 LOT 230619/2153, ONLY THE LATERAL SCREW COULD BE REMOVED. ON PART 15-2814/02 LOT 230703/1306, ONLY THE MEDIAL SCREW COULD BE REMOVED. IT WAS ALSO NOTED THAT THE SCREWS THAT WERE REMOVED WERE VERY DIFFICULT TO GET OUT, AND A 2.5 SCREWDRIVER WAS BROKEN IN THE PROCESS. LOT 230703/1306 WAS CEMENTED INTO PLACE. WAITING INFORMATION ON RETURN OF LOT 230619/2153. CORRECTION 2024-08-21: INITIAL PN / LOT NUMBER INFORMATION RECEIVED WAS INACCURATE. I HAVE RECEIVED THE COMPLAINT SAMPLE AND IT IS LOT 230703/1306, SO LOT 230619/2153 IS THE PART THAT HAS BEEN IMPLANTED, WHICH WAS VERIFIED BY THE REPRESENTATIVE. COMPLAINT SAMPLE WILL BE SHIPPED FOR INVESTIGATION. [CUSTOMER]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189657 ↗
• MalfunctionFeb 13, 2024Separation Failure; Difficult or Delayed Separation; Separation Failure; Difficult or Delayed Separation

  DR. (B)(6) WAS USING AN ENDO MODEL M TIBIAL COMPONENT (B)(6) AND ONE OF THE BLIND SCREWS FOR ATTACHING THE AUGMENT COULD NOT BE REMOVED AND THE HEAD GOT STRIPPED. A SECOND TIBIAL COMPONENT WAS OPENED AND A NEW SCREWDRIVER WAS USED BUT THIS ALSO HAD ONE SCREW THAT WAS LOCKED AND COULD NOT BE REMOVED, LEADING TO THIS SCREW HEAD BECOMING STRIPPED AS WELL. THE AUGMENT USED WAS THEN CEMENTED IN PLACE AND THE SECOND TIBIAL COMPONENT WAS IMPLANTED. SURGERY TIME WAS EXTENDED APPROXIMATELY 15 MINUTES. NOTE: THE SECOND TIBIAL COMPONENT IS WITHIN THE SCOPE OF RECALL R-2022-01, BUT THE FIRST TIBIAL COMPONENT WHICH WAS OPENED, AND DISPLAYED THE SAME ISSUE AS THE TIBIAL COMPONENTS WITHIN THE SCOPE OF THAT RECALL, WAS MANUFACTURED IN DEC 2022, AND THEREFORE IS OUTSIDE THE SCOPE OF THAT RECALL. [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694248 ↗