BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGHT TOTAL KNEE IMPLANT

    MDR report key: 6278999 · Received January 20, 2017

    Report

    Report Number
    MW5067459
    Event Type
    Injury
    Date Received
    January 20, 2017
    Date of Event
    December 13, 2013
    Report Date
    March 3, 2017
    Manufacturer
    STRYKER CORP, INC.
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 03/03/2017 FOR REPORT # MW5067459. REPORTER STATED THAT ADDITIONAL KNEE COMPONENTS MANUFACTURED BY DEPUY ORTHOPEDICS, INC WERE ALSO USED AT THE TIME OF HIS INITIAL SURGERY.

    Description of Event or Problem · 1

    I HAD TWO TOTAL KNEES REPLACEMENT AND ONE TOTAL KNEE REPLACEMENT REVISION (RIGHT SIDE). THE FIRST ONE (LEFT) I HAD DONE BY DR. (B)(6) IN (B)(6) 2010 AND THAT SECOND ONE (RIGHT) I HAD DONE BY DR. (B)(6)) IN (B)(6) 2013. THE COMPLAINT OR REPORT OF INCIDENT REVOLVES AROUND THE EVENTS SURROUNDING THE RIGHT TOTAL KNEE REPLACEMENT AND RESULTING KNEE REPLACEMENT REVISION SURGERY ON THE SAME KNEE. AS I MENTIONED, I HAD TOTAL KNEE REPLACEMENT ON THE RIGHT KNEE IN (B)(6) 2013 AT (B)(6) MEDICAL CENTER BY DR. (B)(6). POST OP WENT VERY WELL AND BETTER THAN THE SURGERY ON MY LEFT KNEE. THE RANGE OF MOTION WAS CONSIDERABLY BETTER THAN MY LEFT KNEE POST-OP. CONSEQUENTLY, I LEFT THE POST REHAB WENT QUITE WELL, BETTER THAN THE LEFT KNEE REHAB AND RETURNED TO WORK BY (B)(6) 2013 WITHOUT MUCH CONTINUED PHYSICAL THERAPY. I WAS WALKING WITH LITTLE OR NO NOTICEABLE PAIN OR STIFFNESS AND WAS PROGRESSING WELL. ALL THAT WOULD CHANGE IN (B)(6) 2013 (THAT SAME YEAR) WHEN, WHILE WALKING ON MY AFTERNOON BREAK AROUND WHERE I WORK, MY RIGHT FOOT CAUGHT ON A PIECE OF BROKEN, UNEVEN CEMENT SIDEWALK CAUSING ME TO FALL FORWARD ON MY RIGHT KNEE AND SIDE. I KNEW ALMOST IMMEDIATELY THAT SOMETHING WAS WRONG AS I NOTICED A BULGING ON THE RIGHT KNEE I HAD NOT NOTICED BEFORE. I WAS ABLE TO WALK BACK INSIDE AND REPORT THE EMPLOYER AS REQUIRED AS IT HAPPENED ON WORK PROPERLY. THIS STARTED THE WORKER'S COMPENSATION PROCESS. I EVENTUALLY PICKED A PHYSICIAN FROM THE WC PHYSICIAN PANEL. I THOUGHT IT WAS FORTUNATE THAT DR. (B)(6) WAS LISTED ON THE PANEL SO I PICKED HIM AS MY WC PHYSICIAN. SINCE HE DID MY LEFT KNEE I WAS CERTAIN HE WOULD HAVE AN IDEAS AS TO THE CAUSE OF THE CURRENT PROBLEM. I WOULD SOON BE PROVEN WRONG. I WAS SENT TO PHYSICAL THERAPY IN (B)(6) 2014, BUT THAT ONLY MADE THE KNEE PAIN WORSE, SO IT WAS STOPPED AND JUST CONTINUED FOCUSING ON THE BACK PAIN CAUSED BY THE FALL. DR. (B)(6) COULD NOT BE MORE CERTAIN AS TO THE CONTINUED PAIN AND STIFFNESS I WAS EXPERIENCING. BESIDES THERAPY, HE HAD ME USE A KNEE IMMOBILIZER WHICH AT THE VERY LEAST HELP SOMEWHAT WITH THE PAIN. I CONTINUED WITH DR. (B)(6) FOR THE MINIMUM TIME REQUIRED UNDER WORKER'S COMP BEFORE SEEING ANOTHER PHYSICIAN NOT ON THE PANEL LIST. I DECIDED TO GO WITH DR. (B)(6) WHO HAD DONE MY RIGHT KNEE. I FELT HE OF ALL PEOPLE, SHOULD BE ABLE TO TELL ME WHAT THE PROBLEM IS WITH MY KNEE SINCE HE PUT IT IN. IT STARTED OUT BETTER THAN WITH DR. (B)(6) AND DR. (B)(6) REMOVED SOME FLUID FROM THE KNEE WITH NEGATIVE RESULTS FOR ANY INFECTION. HE DID ACKNOWLEDGE A PROBLEM BUT WOULD NOT EVEN SPECULATE ABOUT THE CAUSE. IT WAS LOOKING LIKE THIS WAS GOING TO BE A SIMILAR EXPERIENCE TO THAT WITH DR. (B)(6). I ULTIMATELY SOUGHT OUT A THIRD AND FINAL DOCTOR (DR. (B)(6)) WHILE STILL UNDER THE WORKER'S COMPENSATION SYSTEM. HE WAS ABLE TO FAIRLY QUICKLY AND EASILY DETERMINE THROUGH A SIMPLE PROCEDURE THAT IN FACT THERE WAS SOMETHING WRONG WITH THE KNEE REPLACEMENT AS HE HAS SEEN THIS OFTEN BEFORE. MY EMPLOYER'S WORKER'S COMP INSURANCE CARRIER WAS NOTIFIED OF THE FINDINGS, BUT THEY REFUSED TO ACKNOWLEDGE THE CAUSE AND WOULD PROCEED BY LEGALLY OR THROUGH TWO IME EXAMS DENY THE CAUSE SAYING I AM MERELY SUFFERING FROM A KNEE SPRAIN, WHICH I VEHEMENTLY DENIED THROUGH AN ATTORNEY I OBTAINED TO PROTECT MY RIGHTS AND FIGHT THE INSURANCE CARRIER'S DENIAL. CONSEQUENTLY, FOR ALMOST TWO YEARS, I WAS WALKING AROUND WITH A DEFECTIVE KNEE REPLACEMENT. IN (B)(6) 2015, ALMOST TWO YEARS TO THE DAY OF THE INJURY, DR. (B)(6) OPERATED AND, AS BEST HE COULD REPLACED THE DEFECTIVE TIBIAL COMPONENT. DR. (B)(6) WOULD TELL MY WIFE THAT UPON INSPECTION IN THE OPERATING ROOM WITH A SURGICAL TOOL TO TAP THE COMPONENT, THAT PARTICULAR COMPONENT WENT FLYING OUT OF MY KNEE UPON BEING TAPPED. I WAS APPALLED, BUT NOT SURPRISED AS I KNEW THAT SOMETHING WAS NOT RIGHT FOR THOSE TWO YEARS. I FELT I WAS NOT TOLD THE TRUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49492 RIGHT TOTAL KNEE IMPLANT RIGHT TOTAL KNEE IMPLANT LOD STRYKER CORP, INC. RIT123
    49493 OVAL DOME PATELLA 3PEG 35MM PROSTHESIS, KNEE JWH DEPUY ORTHOPEDICS, INC. D12120203
    49494 TIBIAL TRAY ROTATING PLATFORM MB KEEL SIZE4 CEMENTED PROSTHESIS, KNEE JWH DEPUY ORTHOPEDICS, INC. 3524878
    49495 TIBIAL INSERT ROTATING PLATFORM STABILIZED (STAB) 5, 12.5MM PROSTHESIS, KNEE JWH DEPUY ORTHOPEDICS, INC. 3522109

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O| R| S