Endo-Model Modular Knee Prosthesis System 15-2814/03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575316298), received between Jan 24, 2024 and Feb 13, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Separation Failure; Separation Failure

  REPRESENTATIVE (B)(6) REPORTED THAT (B)(6) HAD A TIBIAL COMPONENT THAT WOULD NOT RELEASE ONE OF THE SCREWS - IT SEEMED STRIPPED. IT WAS THE MEDIAL SIDE SCREW. THE OTHER SCREW CAME OUT WITH NO ISSUE. SURGERY TIME WAS NOT EXTENDED AS THE AUGMENT WAS THEN JUST CEMENTED IN PLACE. [CUSTOMER]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694249 ↗
• InjuryJan 24, 2024Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  DURING THE SURGERY ONE SCREW CAME OUT, THE SECOND SCREWED. SURGERY TIME WAS PROLONGED, BECAUSE THEY USED THE SCREW EXTRACTION KIT UNNECESSARILY, IN THE END THEY ONLY PUT ONE SCREW FASTENING AND CEMENT, AS SUGGESTED IN PREVIOUS FSN AND THE IMPLANT WAS SUCCESSFULLY COMPLETED. WE ARE REPORTING THE EPISODE BECAUSE IN THE FSN REF. (B)(4), AFFECTED ITEMS SHOULD HAVE BEEN ONLY THOSE IN PRODUCTION UNTIL (B)(6) 2022, WHEREAS THIS ITEM WAS PRODUCED IN (B)(6) 2023. [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571268 ↗