NexGen® 5986-57-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024218888), received between Jan 7, 2020 and Oct 16, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20460165 ↗
• InjuryJun 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS A PENDING REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint effusion; Osteolysis; Pain

  MAUDE report 19548287 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 19 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN AND STIFFNESS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9557230 ↗