Gender Solutions® Natural-Knee® 00-5418-000-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024573666), received between Apr 5, 2022 and Apr 5, 2022 — classified as 2 injuries.

7 other recalls cover devices cleared under the same FDA submission (K073286, K173057); they may or may not involve this specific model.

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 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT IS REPORTING PAIN, AMBULATION DIFFICULTIES, AND INSTABILITY OF THE KNEE. NO REVISION PROCEDURE HAS BEEN SCHEDULED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 14015240 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain

  MAUDE report 14014494 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073286, K173057. One submission often covers many models, so check the product and lot details in each record.

• Z-2092-2023 · May 19, 2023 · Terminated
  NexGen Precoat Stemmed Tibial Plate Size 5
• Z-0321-2020 · Oct 10, 2019 · Terminated
  Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800
• Z-2584-2014 · Jul 10, 2014 · Terminated
  Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing i
• Z-2585-2014 · Jul 10, 2014 · Terminated
  Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is
• Z-2582-2014 · Jul 10, 2014 · Terminated
  Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is
• Z-2583-2014 · Jul 10, 2014 · Terminated
  Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing
• Z-1248-2014 · Feb 25, 2014 · Terminated
  Gender Solutions" Natural-Knee Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT