Kinemax 6476-8-270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327045369), received between Apr 11, 2019 and Mar 6, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K223069, K896452, K904208); 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.

• InjuryMar 6, 2024Degraded; Fracture; Degraded; Fracture

  REVISION OF RIGHT MRH DUE TO IMPLANT BREAKAGE. PRIMARY PROCEDURE PERFORMED ON (B)(6) 2019. FEMORAL STEM SNAPPED FROM MRH FEMORAL COMPONENT IN SITU. DATE OF BREAKAGE UNKNOWN, REVISION WAS PERFORMED ON (B)(6) 2024. FEMORAL AND TIBIAL IMPLANTS REMOVED. REVISED TO DISTAL FEMORAL AND PROXIMAL TIBIAL GMRS.

  Patient problems: Insufficient Information

  MAUDE report 18844274 ↗
• InjuryApr 11, 2019Break; Break

  REVISION OF AN MRH FEMUR DUE TO A BROKEN 155MM CEMENTED STEM. THE MRH TIBIA DID NOT REQUIRE REVISION, BUT THE FEMUR WAS REVISED TO A GMRS FEMORAL COMPONENT.

  Patient problems: Injury

  MAUDE report 8503553 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223069, K896452, K904208. One submission often covers many models, so check the product and lot details in each record.

• Z-1614-2015 · Feb 27, 2015 · Terminated
  Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modul