FDA Adverse Event Injury Summary report: N

STRYKER TRIDENT TOTAL CERAMIC/CERAMIC HIP

MDR report key: 2093915 · Received May 11, 2011

Report

Report Number
MW5020603
Event Type
Injury
Date Received
May 11, 2011
Report Date
May 11, 2011
Manufacturer
STRYKER
Product Code
MRA
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN 2003, I HAD A SULZER RIGHT TRIDENT CERAMIC ON CERAMIC TOTAL HIP REPLACEMENT. I SOMETIMES HEAR SQUEAKS FROM THIS AREA. SOME SQUEAKS COME FROM THE KNEE AREA, MY ORTHOPAEDIC SURGEON INDICATED THAT SQUEAKS FROM THE HIP CAN TRAVEL FROM THE HIP TO THE KNEE AREA DOWN THE FEMORAL STEM. MY RIGHT FOOT TURNS OUT A LITTLE AND IT MIGHT BE DUE TO ANY DEGRADATION FROM THE FEMORAL STEM/ACETABULAR CUP COUPLING. I AM AFRAID THAT OVER TIME THIS SQUEAKING MIGHT GET WORSE AND THAT DEGRADATION MIGHT RESULT IN THE NEED FOR A REPLACEMENT SURGERY. I HAVE HAD A RECENT X RAY TAKEN THERE AND IT SHOWED THE PRESENCE OF HETEROTROPIC OSSIFICATION, WHICH OCCURS WHEN THERE ARE PARTICULATES WHICH COME FROM A TOTAL HIP REPLACEMENT AND THESE PARTICLES CAUSE BONE LOSS. I SPOKE WITH A WOMAN RECENTLY WHO HAD A TOTAL HIP REPLACEMENT WITH A STRYKER TRIDENT CERAMIC ON CERAMIC SYSTEM LIKE MINE. SHE HAD NO PAIN FOR MANY YEARS. SHE ENTERED AND WON A CLASS ACTION SUIT AGAINST STRYKER AND A FEW YEARS LATER, STARTED TO HAVE PAIN IN THE STRYKER HIP. IN (B)(6) 2011, SHE IS HAVING ANOTHER SURGERY DURING WHICH THE SURGEON WILL DETERMINE IF SHE NEEDS TO REPLACE THE HIP, IT'S CALLED EXPLORATORY SURGERY. I FEAR THAT THIS MIGHT BE MY ROUTE DOWN THE ROAD AND SINCE I'M (B)(6) NOW HAVING SURGERY LATER IN LIFE WOULD BE DIFFICULT. STRYKER MFG TRIDENT CERAMIC ON CERAMIC HIP REPLACEMENT SYSTEMS IN (B)(6) IN A FACTORY THAT HAD THE FDA ISSUE A CITATION TO STOP MFG. THEY CONTINUED TO MANUFACTURE. THE FDA ISSUED A SECOND CITATION TO STOP MFG. THEY AGAIN CONTINUED TO MANUFACTURE. IF MY HIP WAS MADE DURING THIS TIME OF FDA MANDATE TO STOP MFG IT REPRESENTS A MEDICAL DEVICE THAT WAS RECALLED AND I SHOULD BE ENTITLED TO A REWARD FROM STRYKER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 STRYKER TRIDENT TOTAL CERAMIC/CERAMIC HIP TRIDENT CERAMIC ON CERAMIC TOTAL HIP REPLACEMENT MRA STRYKER
2 TRIDENT PSL ACETABULAR SHELL TRIDENT CERAMIC ON CERAMIC TOTAL HIP REPLACEMENT MEH STRYKER
3 TRIDENT O ALUMINA INSERT TRIDENT CERAMIC ON CERAMIC TOTAL HIP REPLACEMENT MRA STRYKER
4 ACCOLADE TMZF HIP STEM TRIDENT CERAMIC ON CERAMIC TOTAL HIP REPLACEMENT MEH STRYKER
5 ALUMINA V40 TAPER HEAD TRIDENT CERAMIC ON CERAMIC TOTAL HIP REPLACEMENT MRA STRYKER

Patients

Seq Age Sex Outcome Treatment
1 61 YR Disability