inforMED
InjuryKRO

MRH KNEE FEMORAL COMPONENT

Received Mar 2, 2026 · Event occurred Jan 6, 2026

Report MW5184568 · MDR key 24485930

Device

Generic name

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

Model number

6481-1-140

Lot number

C3X6D

Product problems

  • Crack

Patient

33 YR · Male

  • Cancer

Narrative

Description of Event or Problem

I'M WRITING WITH A CONCERN AND A COMPLAINT ABOUT STRYKER CORPORATION'S MRH KNEE REPLACEMENT PROSTHESIS AND THEIR FAILURE RATE. 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. ATTACHED PLEASE FIND THE SERIAL NUMBERS OF ALL THE STRYKER DEVICES INCLUDED IN THAT SURGERY. DESPITE CLAIMS ON THE STRYKER WEBSITE THAT THEIR 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 STRYKER'S WEBSITE CLAIMS SHOULD LAST MUCH, MUCH LONGER. NONE OF THESE SURGERIES ARE SIMPLE PROCEDURES. THEY'RE LONG AND INVOLVED AND REQUIRE A LENGTHY RECOVERY. BECAUSE OF THE CANCER TREATMENTS AND THE MORE COMPLICATED SURGERY IN 2015, I MISSED MORE THAN A YEAR OF COLLEGE. IN 2022, I WAS OFF OF WORK WITHOUT PAY FOR SIX WEEKS. WHILE I'M HOPING THE SURGERY THIS TIME MAY NOT BE AS COMPLEX OR INVOLVED AS EITHER OF THE PREVIOUS ONES, IT WILL STILL REQUIRE A MONTH OR MORE OF RECOVERY. THAT'S ON TOP OF ALL THE MEDICAL EXPENSES I'VE ALREADY INCURRED AND WILL HAVE TO INCUR AGAIN. I MIGHT UNDERSTAND THE FAILURES IF I WAS PLACING UNDUE BURDENS ON THESE DEVICES BEYOND WHAT THEY'RE DESIGNED TO WITHSTAND. BUT I'M NOT. I WORK IN AN OFFICE SETTING AND SIT AT A DESK DURING MY ENTIRE WORKDAY. THE ONLY "DEMANDS" I PLACE ON THESE DEVICES IS MINIMAL WALKING THROUGHOUT THE DAY TO GET TO AND FROM MY DESK. OUTSIDE THE OFFICE, I ALSO REFRAIN FROM PLACING ANY UNDUE STRAIN ON MY PROSTHETIC RIGHT KNEE. I ASSUME STRYKER IS AWARE OF THE FAILURE OF THEIR DEVICE IMPLANTED IN 2015 SINCE EVEN THEIR OWN SALES REP NOTED HOW UNUSUAL THAT FAILURE WAS. AND I'M ASSUMING THE COMPANY WILL BE INFORMED AGAIN THIS TIME AFTER THE FAILURE OF YET ANOTHER COMPONENT IMPLANTED IN 2022. I'M CONFIDENT THAT THESE FAILURES HAVE NOTHING TO DO WITH THE SURGERIES PERFORMED OR WITH THE MINIMAL STRESS I PUT ON THE DEVICES, BUT RATHER WITH THE DEVICES THEMSELVES. GIVEN THE COMPANY REPRESENTS ITS DEVICES AS HAVING LIFESPANS FAR LONGER THAN MY EXPERIENCE DEMONSTRATES, I THINK AN INVESTIGATION OF THE FAILURES -- AND THE UNDERLYING PRODUCT DESIGN, MATERIALS USED AND MANUFACTURING PROCESS -- IS WARRANTED. PT CODE: 3262. DEVICE CODE: 1135. REF: MW5184567.