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Kinematic 6485-2-211Recalls & reported problems

Howmedica Osteonics Corp. · Rotating Hinge Knee · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327047530), received between Jun 9, 2021 and Jun 9, 2021 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K001548, K223069, K972863); 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Limb Fracture1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED: "LEFT KNEE REVISION DUE TO TIBIA FRACTURE. NO MORE INFORMATION IS AVAILABLE PER DOCTOR." AN ALL POLY TIBIAL COMPONENT, TIBIAL BEARING COMPONENT, BUMPER INSERT, AXLE, AND BUSHINGS WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE TIBIAL BEARING COMPONENT, INSERT, AXLE, AND BUSHINGS, AND RE-CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Limb Fracture

    MAUDE report 11963997 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001548, K223069, K972863. One submission often covers many models, so check the product and lot details in each record.

  • Z-0921-2024 · Dec 1, 2023 · Open, Classified
    DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
  • Z-0920-2024 · Dec 1, 2023 · Open, Classified
    DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
  • Z-0919-2024 · Dec 1, 2023 · Open, Classified
    DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
  • Z-0922-2024 · Dec 1, 2023 · Open, Classified
    DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page