Natural-Knee® 6307-01-210Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024258730), received between Jun 20, 2024 and Jun 20, 2024 — classified as 1 injury.

8 other recalls cover devices cleared under the same FDA submission (K173057, K936159); 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 16, 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.

• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE YEAR POST-OP, THE PATIENT WAS EXPERIENCED ONGOING QUADRICEP MUSCLE WEAKNESS AND ATROPHY, PAIN, STIFFNESS, LIMITED RANGE OF MOTION, AND INSTABILITY. THE PATIENT UNDERWENT ADDITIONAL COURSES OF PHYSICAL THERAPY WITHOUT RELIEF. SUBSEQUENTLY, THE PATIENT WAS REVISED. THE INTRA-OP TISSUE SAMPLE DISPLAYED FIBROCONNECTIVE TISSUE AND REACTIVE SYNOVIUM WITH FIBROSIS. ALL COMPONENTS WERE REVISED EXCEPT THE PATELLA. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Joint Laxity; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19575474 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173057, K936159. 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 0052200
• Z-1033-2018 · Nov 29, 2017 · Terminated
  NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Struct
• Z-0839-2016 · Jan 11, 2016 · Terminated
  NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II
• Z-1262-2014 · Feb 25, 2014 · Terminated
  Natural-Knee II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1
• Z-1249-2014 · Feb 25, 2014 · Terminated
  Natural-Knee N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1
• Z-0078-2014 · Aug 30, 2013 · Terminated
  Natural-Knee II Femoral Component
• Z-0075-2014 · Aug 30, 2013 · Terminated
  Natural-Knee Flex Femoral Component. Provides increased flexion capability.