Kinematic 6485-2-216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327047547), received between Feb 7, 2023 and Feb 7, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

Recent adverse event reports

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

• InjuryFeb 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT TOTAL FEMUR WAS REVISED. AS REPORTED: "PT. PRESENTED WITH LOSS OF FUNCTION OF THE LEFT LEG AFTER RADIATION THERAPY FOLLOWING A TOTAL-FEMUR REPLACEMENT WHICH WAS REVISED MOST RECENTLY ON (B)(6) 2022. THE DOCTOR OPTED TO REVISE THE PT¿S LEFT LEG USING A ¿TIBIAL TURN-UP¿ TECHNIQUE. ALL PREVIOUS COMPONENTS WERE EXPLANTED, AND A CEMENTED-HEMIARTHROPLASTY WAS IMPLANTED IN ORDER TO GIVE THE PATIENT A ¿SEMI-FUNCTIONAL HIP ALLOWING HIM TO SIT-UP IN A WHEEL-CHAIR.¿ AS PER SALES REP, ALL IMPLANTS IMPLANTED IN (B)(6) 2022 AND AN ALL POLY COMPONENT IMPLANTED (B)(6) 2022 WERE REVISED. REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

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

  MAUDE report 16309960 ↗

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