NEXGEN® 00-5886-045-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024310087), received between Mar 12, 2020 and Apr 28, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY ON APPROXIMATELY 19 MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN AND STIFFNESS ON APPROXIMATELY 6 MONTHS POST-IMPLANTATION. THIS REVISION WAS FOR RESURFACING OF PATIENT¿S NATURAL PATELLA AND LATERAL RELEASE.

  Patient problems: Pain

  MAUDE report 10006005 ↗
• InjuryMar 12, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST IMPLANTATION, THE PATIENT DEVELOPED AN INFECTION OF THE RIGHT KNEE ARTHROPLASTY. THE PATIENT UNDERWENT A WASHOUT OF THE KNEE. SUBSEQUENTLY, THE PATIENT HAS NOW BEEN REVISED OF THE KNEE IMPLANTS APPROXIMATELY 15 MONTHS POST INITIAL IMPLANTATION DUE TO SEPTIC LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 9824245 ↗