Endo-Model Standard Knee Prosthesis System 15-0027/14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575432110), received between Jan 9, 2024 and Apr 24, 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.

• InjuryApr 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAS HAD MULTIPLE REVISIONS. . THE SUBJECT DEVICES WERE IMPLANTED DURING REVISION KNEE ARTHROPLASTY ON (B)(6) 2024. SUBSEQUENTLY, ON (B)(6) 2024 THE PATIENT PRESENTED TO THE EMERGENCY DEPT. WITH INFECTED KNEE WOUND DEHISCENCE AND WAS TAKEN TO SURGERY FOR IRRIGATION AND DEBRIDEMENT DURING WHICH THE FEMORAL COMPONENT AND TIBIAL PLATEAU WERE REPLACED AS PART OF THE WASHOUT. NO INFORMATION ALLEGES IMPLANT PERFORMANCE ISSUES OR OBSERVED IMPLANT DAMAGE.

  Patient problems: Medical device site infection

  MAUDE report 19173638 ↗
• InjuryJan 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT PRESENTED WITH DIFFICULTY WALKING, COMBINED WITH CLICKING AND LOCKING IN THE RIGHT KNEE SUBSEQUENT TO A DEC 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 01/23/2024.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 18477841 ↗