FDA Adverse Event Injury Summary report: N

PALACOS G BONE CEMENT

MDR report key: 5353561 · Received January 5, 2016

Report

Report Number
MW5059079
Event Type
Injury
Date Received
January 5, 2016
Date of Event
October 29, 2014
Report Date
January 5, 2016
Manufacturer
ZIMMER
Product Code
LOD
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ALLERGY TO COMPONENT OF CEMENT IN L KNEE REPLACEMENT. ON (B)(6) 2014, I HAD A KNEE REPLACEMENT TO MY L KNEE. MY FIRST KNEE REPLACEMENT 10 YEARS EARLIER TO MY R KNEE WAS A BREEZE AND BY 9 MONTHS, I WAS BACK TO ZUMBA. FROM THE VERY BEGINNING AFTER THE L REPLACEMENT WITH A DEPUY ROTATING PLATFORM, THE L KNEE WAS HOT, SWOLLEN, TENDER, AND AFER THE PHYSICIAN THERAPY, MY KNEE WOULD BE ON FIRE FOR 1-2 DAYS. MAKING A LONG STORY SHORT (I AM A PHYSICIAN), I BELIEVE I HAVE AN ALLERGY TO THE BENZOYL PEROXIDE IN THE CEMENT WHICH IS CAUSING CONTINUED PAIN AND DISABILITY. REASONING BEHIND THIS HYPOTHESIS: I HAD AN ALLERGY TO LOVANOX INJECTIONS WHICH WERE A CLASSIC TYPE 4 HYPERSENSITIVITY REACTION WITH LARGE PAINFUL ULCERS AT THE INJECTION SITES WHICH DEVELOPED OVER A FEW DAYS AFER THE INJECTION. THERE ARE SOME RESEARCH PAPERS THAT SHOW THE LOVANOX ALLERGY IS ACTUALLY TO THE BENZYL ALCOHOL AND NOT TO THE LOWER-MOLECULAR WEIGHT HEPARIN. THEREFORE, IT MAKES SENSE I COULD HAVE AN ALLERGY TO BENZOYL PEROXIDE. (ONE HAD ONE BENZYL GROUP AND THE OTHER HAS 2 BENZYL GROUPS). THERE IS NOT A BLOOD TEST AVAILABLE FOR TESTING ALLERGY TO BENZOYL PEROXIDE. MY HOMEMADE SKIN PATCH TEST (UNDER THE DIRECTION OF AN ALLERGIST) WAS MILDLY POSITIVE TO BENZOYL PEROXIDE ACNE CREAM, WHICH WAS OVERSHADOWED BY THE FLORID REACTION I HAD TO THE BAND AID SPORT STRIP. JOHNSON AND JOHNSON HAS BEEN STONE-WALLING ME, AND I CANNOT FIND OUT IF THERE IS BENZOYL PEROXIDE IN THEIR ADHESIVE. SEARCHING THE PTS FOR THE COMPONENTS OF THE ADHESIVE IN BAND AIDS HAS BEEN DEAD END. NOT ALL CEMENTS HAVE BENZOYL PEROXIDE BUT THERE IS DEFINITELY BENZOYL PEROXIDE IN THE CEMENT USED ON MY L KNEE, AS DOCUMENTED IN THE SAFETY DATA SHEET. I HAVE BEEN TO AN ALLERGIST (WHO WAS BEFUDDLED), AND REHAB DOC WHO THOUGHT I NEEDED INSERTS IN MY SHOES, A RHEUMATOLOGIST WHO TOLD ME IT WAS BECAUSE I HAD A LEG LENGTH DISCREPANCY, AND THREE ORTHO SURGEONS WHO STATED THAT I HAVE CONTINUED PAIN BECAUSE I NEED MORE PHYSICAL THERAPY. ULTIMATELY, AFTER DOING ALL THIS RESEARCH TO CONCLUDE THAT IT IS A TYPE 4 HYPERSENSITIVITY REACTION TO THE BENZOYL PEROXIDE, A VERY SMART YOUNG PHYSICIAN WHO WORKS FOR ME PRESCRIBED A HIGH-DOSE PREDNISONE TAPER WITH 3 OTHER MEDICATION (H-2 BLOCKER, SINGULAIR, AND HYDROXYZINE) TO TRY AND TEMPER THE HYPERSENSITIVITY. MY PAIN IS A BIT BETTER, BUT NO ACCEPTABLY BETTER. BOTTOM LINE: ORTHOPEDIC SURGEONS DO NOT BELIEVE IN ALLERGIES. THE FDA CAN DO SOMETHING ABOUT THIS EVER INCREASING PROBLEM AS MORE AND MORE OF US ARE AGING AND REQUIRING JOINT REPLACEMENTS. THE FDA CAN HOLD THE DEVICE MANUFACTURERS RESPONSIBLE FOR CONTINUED SURVEILLANCE AND DATA-COLLECTION POST-IMPLANT, AND MAE THE INFO PUBLIC. THE FDA CAN ISSUE A WARNING ABOUT POSSIBLE METAL AND CEMENT ALLERGIES TO ORTHOPEDIC SURGEONS (THEY ARE STUBBORN PEOPLE, SO THEY MIGHT NOT EVEN BELIEVE THE FDA THERE NEEDS TO BE TRANSPARENCY IN THE CHEMICAL MAKE-UP OF THE CEMENT, ADHESIVES, DEVICES, ETC. IT WAS A MIRACLE THAT I FOUND THE SAFETY DATA SHEET FOR THE CEMENT THROUGH A (B)(6) SEARCH. I AM STILL WORKING ON TRYING TO CONVINCE J&J TO TELL ME IF THERE IS BENZOYL PEROXIDE IN THEIR SPORT STRIP ADHESIVE. THE FDA NEEDS TO HAVE A REGISTRY OF ADVERSE REACTIONS AFTER A JOINT REPLACEMENT. WITH THAT SAID: ARE YOU ABLE TO FIND OUT IF THERE IS BENZOYL PEROXIDE IN BANDAID SPORT STRIPS? IS THERE ANYTHING ELSE THE FDA CAN DO TO HELP ME?

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
4852 PALACOS G BONE CEMENT BONE CEMENT LOD ZIMMER
4917 DEPUY ROTATING PLATFORM KNEE REPLACEMENT JWH DEPUY

Patients

Seq Age Sex Outcome Treatment
1 58 YR Other