NexGen® 00-5850-075-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024196377), received between Oct 24, 2024 and Oct 24, 2024 — classified as 2 injuries.

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.

• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL ROTATING HINGE KNEE ARTHROPLASTY PERFORMED AND SUBSEQUENTLY UNDERWENT TWO REVISION SURGERIES DUE TO DISASSOCIATION OF THE HINGE POST EXTENSION AS WELL AS A QUADRICEPS TENDON REPAIR PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS CONTINUED TO EXPERIENCE SIGNIFICANT PAIN WHICH INTERFERES WITH AMBULATION AND DAILY ACTIVITIES FOR TWO (2) YEARS FOLLOWING THE MOST RECENT PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION HAS BEEN REPORTED TO DATE TO ADDRESS THE CONTINUED PAIN. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20523458 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL ROTATING HINGE KNEE ARTHROPLASTY PERFORMED AND SUBSEQUENTLY UNDERWENT TWO REVISION SURGERIES DUE TO DISASSOCIATION OF THE HINGE POST EXTENSION. APPROXIMATELY THREE (3) WEEKS FOLLOWING THE SECOND REVISION SURGERY, THE PATIENT PRESENTED WITH SIGNIFICANT PREPATELLAR SWELLING AND UNDERWENT ADDITIONAL SURGERY TO REPAIR THE QUADRICEPS TENDON. DURING THE PROCEDURE, PREPATELLAR BURSITIS WAS REMOVED, AND TWO AREAS OF PARTIAL RUPTURE OF THE VASTUS MEDIALIS OFF THE QUADRICEPS TENDON WERE NOTED. THERE WERE NO CONCERNS WITH THE IMPLANTS WHICH WERE ALL RETAINED. THE TENDON WAS REPAIRED WITHOUT COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Bursitis; Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 20523296 ↗