MRH 6481-1-141Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327045192), received between Mar 18, 2026 and Mar 18, 2026 — classified as 1 injury.

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

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.

• InjuryMar 18, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE ALLEGATION OF IMPLANT BREAKAGE AFTER REVISION. I WAS DIAGNOSED WITH BONE CANCER IN MY RIGHT TIBIA IN 2015. IN (B)(6) OF THAT YEAR, FOLLOWING FOUR MONTHS OF CHEMOTHERAPY, THAT CANCER-AFFECTED AREA WAS SURGICALLY REMOVED AND SEVERAL STRYKER DEVICES WERE IMPLANTED. THE DEVICES CONTAINED BOTH TIBIAL AND FEMORAL COMPONENTS. ATTACHED PLEASE FIND THE SERIAL NUMBERS OF ALL THE STRYKER DEVICES INCLUDED IN THAT SURGERY. IN (B)(6) OF 2022, THE FEMORAL PORTION OF THAT DEVICE CRACKED AND HAD TO BE REPLACED. THE SURGEON, AND THE STRYKER SALES REP WHO WAS IN THE OPERATING ROOM AT THE TIME, SAID THEY HAD NEVER SEEN A FAILURE LIKE IT. DESPITE CLAIMS ON YOUR WEBSITE THAT YOUR KNEE REPLACEMENT DEVICES LAST 20 YEARS OR MORE, THE FEMORAL PORTION OF THE DEVICES IMPLANTED IN 2022 HAS NOW CRACKED AND I NEED YET ANOTHER SURGERY TO REPLACE IT. THAT WILL MAKE THREE SURGERIES IN A LITTLE OVER TEN YEARS -- THE LATEST LESS THAN FOUR YEARS AFTER THE LAST ONE -- TO IMPLANT THE SAME COMPONENTS THAT YOUR WEBSITE CLAIMS SHOULD LAST MUCH, MUCH LONGER. AS I'M SURE YOU'RE AWARE, NONE OF THESE SURGERIES ARE SIMPLE PROCEDURES. THEY'RE LONG AND INVOLVED AND REQUIR

  Patient problems: Insufficient Information

  MAUDE report 24627644 ↗