NexGen® 90-5970-50-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024644557), received between Oct 13, 2022 and Oct 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING KNEE ARTHROPLASTY WHILE THE SURGEON WAS INSERTING THE ARTICULAR SURFACE, THE DEVICE WOULD NOT SEAT ON THE TIBIAL TRAY. ANOTHER ARTICULAR SURFACE OF A LARGER SIZE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598761 ↗